Surgical interventions for presbyopia.

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Learn more: PMC Disclaimer | PMC Copyright Notice Cochrane Database Syst Rev . 2025 Apr 14;2025(4):CD015711. doi: 10.1002/14651858.CD015711.pub2 Search in PMC Search in PubMed View in NLM Catalog Add to search Surgical interventions for presbyopia Rosa Alvarado-Villacorta Rosa Alvarado-Villacorta 1 Cornea and Refractive Surgery Department, Asociación para Evitar la Ceguera en México I.A.P, Mexico City, Mexico 2 Master in Clinical Epidemiology Program, Universidad Peruana Cayetano Heredia, Lima, Peru Find articles by Rosa Alvarado-Villacorta 1, 2, ✉ , Tsz Wing Yim Tsz Wing Yim 3 Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA Find articles by Tsz Wing Yim 3 , Everardo Hernandez-Quintela Everardo Hernandez-Quintela 4 Division of Comprehensive Ophthalmology, Wilmer Eye Institute, Johns Hopkins Medicine, Baltimore, USA Find articles by Everardo Hernandez-Quintela 4 , Enrique De La Torre-Gonzalez Enrique De La Torre-Gonzalez 1 Cornea and Refractive Surgery Department, Asociación para Evitar la Ceguera en México I.A.P, Mexico City, Mexico Find articles by Enrique De La Torre-Gonzalez 1 , Cesar Antonio Loza Munarriz Cesar Antonio Loza Munarriz 5 Clinical Epidemiology Unit, Universidad Peruana Cayetano Heredia, Lima, Peru Find articles by Cesar Antonio Loza Munarriz 5 , Maria José Martinez-Zapata Maria José Martinez-Zapata 6 Iberoamerican Cochrane Centre, Institut de Recerca Sant Pau (IR Sant Pau), CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain Find articles by Maria José Martinez-Zapata 6 Editor: Cochrane Central Editorial Service Author information Article notes Copyright and License information 1 Cornea and Refractive Surgery Department, Asociación para Evitar la Ceguera en México I.A.P, Mexico City, Mexico 2 Master in Clinical Epidemiology Program, Universidad Peruana Cayetano Heredia, Lima, Peru 3 Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA 4 Division of Comprehensive Ophthalmology, Wilmer Eye Institute, Johns Hopkins Medicine, Baltimore, USA 5 Clinical Epidemiology Unit, Universidad Peruana Cayetano Heredia, Lima, Peru 6 Iberoamerican Cochrane Centre, Institut de Recerca Sant Pau (IR Sant Pau), CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain ✉ Rosa Alvarado-Villacorta, Cornea and Refractive Surgery Department, Asociación para Evitar la Ceguera en México I.A.P, Mexico City, Mexico. [email protected] . ✉ Corresponding author. Collection date 2025. Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The content of this article (as distinct from the content of the ‘Supplementary materials’, ‘Related’ and ‘About this Review’ sections) has been peer reviewed and prepared for publication in accordance with Cochrane’s editorial policies . Though the aim of these processes is, among other things, to check the accuracy of such content, responsibility for the content remains that of the author(s) and Cochrane gives no representations or warranties of any kind in relation to, and accepts no liability for any reliance on or use of, the content of the article. PMC Copyright notice PMCID: PMC11995687  PMID: 40226888 This article is an update of " Surgical interventions for presbyopia " in volume 2023, CD015711. Abstract Rationale Presbyopia is a progressive condition that everyone who lives long enough will experience, irrespective of gender, ethnicity, or economic status. A wide range of surgical options has emerged for overcoming near and intermediate visual impairment; however, questions about the effectiveness and safety of these interventions remain unanswered. Given the global burden of presbyopia and the need to improve decision‐making practices in tailoring management and allocating scarce resources, it is essential to review the available evidence on this issue systematically. Objectives The primary objective was to compare the effectiveness and safety of surgical interventions for people with presbyopia; the secondary objective was to produce a brief economic commentary summarizing relevant economic evaluations that have compared different surgical interventions. Search methods We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, two other databases, and trial registries on 29 February 2024. Eligibility criteria We included randomized controlled trials in participants with presbyopia, including those who had pseudophakic presbyopia with or without previous corneal refractive surgery, in which one surgical intervention was compared with another or a modified version of the same intervention. We excluded trials that had enrolled participants mainly for cataract surgery or who had other ocular comorbidities such as glaucoma, diabetes mellitus, age‐related macular degeneration, or myopic retinopathy. Outcomes Outcomes of interest were spectacle independence for near and intermediate vision, change in quality of life (QoL), improvement in or maintenance of binocular uncorrected distance visual acuity (VA), participant satisfaction, change in binocular contrast sensitivity (CS), and frequency of adverse events (AE). Risk of bias We used the Cochrane RoB 2 tool to assess bias for each outcome in each included trial. Synthesis methods We planned to synthesize results for each outcome using meta‐analysis (random‐effect models) where possible, or else use synthesis without meta‐analysis methods. However, due to insufficient data for each pairwise comparison (i.e. only one study reported data per analysis), we employed narrative synthesis. We used GRADE to assess the certainty of evidence for each outcome. Included studies We included four studies that enrolled 300 participants (600 eyes); most participants were women; mean ages ranged between 46 and 58 years. Two trials were conducted in Croatia, one in Egypt, and one in Turkey. Three studies compared a surgical intervention for presbyopia with another, and one study compared a surgical intervention with a modified version of the same intervention. All enrolled participants had presbyopia without cataracts, other comorbidities, or previous ocular surgery. No trials were registered before initiation. One trial reported no funding and no financial conflicts of interest; the others provided no information. Synthesis of results Only one study provided data per pairwise comparison of interventions. No study reported outcomes at 12 months or provided economic data. Diffractive bifocal intraocular lens (IOL) versus refractive bifocal IOL after refractive lens exchange (RLE) At six months, the diffractive bifocal IOL group showed no evidence of a difference in spectacle independence for near vision (risk ratio [RR] 1.06, 95% confidence interval [CI] 0.82 to 1.37; 100 participants; low‐certainty evidence), intermediate vision (RR 0.93, 95% CI 0.81 to 1.07; 100 participants; low‐certainty evidence), or participant satisfaction (RR 1.09, 95% CI 0.99 to 1.19; 100 participants; very low‐certainty evidence) compared with refractive bifocal IOL implantation after RLE. Ocular AEs may be less frequent in the diffractive bifocal IOL group (RR [non‐event] 1.38, 95% CI 1.05 to 1.81; 100 participants; very low‐certainty evidence). Changes in QoL, binocular CS, or binocular uncorrected distance VA were not reported. Diffractive bifocal IOL after RLE versus laser‐assisted in situ keratomileusis (LASIK) monovision At six months, diffractive bifocal IOL implantation showed no evidence of a difference compared with LASIK monovision in spectacle independence for near vision (RR 1.07, 95% CI 0.92 to 1.25; 100 participants; low‐certainty evidence), the proportion of participants achieving 0.0 LogMAR or better distance vision (RR 0.87, 95% CI 0.69 to 1.11; 100 participants; low‐certainty evidence), or improvement in participant satisfaction (RR 0.98, 95% CI 0.89 to 1.07; 100 participants; low‐certainty evidence). However, LASIK monovision may improve spectacle independence for intermediate vision at six months (RR 0.82, 95% CI 0.72 to 0.94; 100 participants; low‐certainty evidence) and may reduce ocular AE (RR [non‐event] 0.58, 95% CI 0.46 to 0.74; 100 participants; very low‐certainty evidence). Changes in QoL or binocular CS were not reported. Diffractive trifocal IOL versus extended depth of focus IOL after RLE No data on spectacle independence, participant satisfaction, binocular CS, or ocular AE were reported. At three months after surgery, neither of the two interventions may offer a clinically significant advantage over the other, either for QoL scores (mean difference [MD] ‐0.08, 95% CI‐0.15 to ‐0.01; 74 participants; very low‐certainty evidence) or binocular uncorrected near VA (MD 0.01, 95% CI ‐0.02 to 0.04; 74 participants), intermediate VA (MD 0.01, 95% CI ‐0.01 to 0.03; 74 participants) or distance VA (MD 0.01, 95% CI ‐0.01 to 0.03; 74 participants; low‐certainty evidence). Modified wavefront‐guided (WG) LASIK versus conventional WG LASIK We found no data for spectacle independence, QoL, participant satisfaction, or ocular AE. Data from one study suggested no evidence of a difference between the interventions in improvement in uncorrected distance VA or change in binocular CS at three months. However, we had concerns about potential bias, and the data were insufficient for quantitative analysis. Authors' conclusions The available data were limited to short‐term (three months) and mid‐term (six months) outcomes and provided low‐ or very low‐certainty evidence. Little information was reported regarding QoL, binocular CS, or ocular AEs; no study addressed economic aspects of interventions. Funding This Cochrane review had no internal source of support. External sources: National Eye Institute, National Institutes of Health, USA; Public Health Agency, UK; Queen's University Belfast, UK. Registration Protocol (2023): doi.org/10.1002/14651858.CD015711 Plain language summary What are the benefits and risks of different types of surgery for people with presbyopia? Key Messages Based on current evidence, the relative benefits and risks of different types of surgery for treating people with presbyopia (difficulties in reading or seeing close up) are unclear at three to six months after treatment. There was no information about the effects beyond six months after treatment. No study looked at the balance of costs and how well the different treatments worked. Future well‐designed studies should measure the longer‐term benefits and risks of different types of surgery for improving vision in people with presbyopia. They should also assess the impact on well‐being, the ability to distinguish between small differences in light and dark (contrast sensitivity), and visual disturbances. What is presbyopia? Presbyopia refers to the inability of the eye to focus at different distances, which occurs with aging. People with presbyopia gradually lose the ability to see clearly at near distances (close up, e.g. reading) or at intermediate distances (e.g. using a computer). This condition eventually affects everyone and may significantly impact their well‐being, regardless of their literacy or profession. How is presbyopia treated? Optical correction for presbyopia includes using glasses or contact lenses to improve vision at near and intermediate distances. However, these approaches have limitations and may not be appropriate for everyone. These shortcomings, added to increasingly demanding visual requirements for tasks at near and intermediate distances, have led to the development of several surgical options for presbyopia correction. Most available types of surgery change the shape of the cornea (the clear outer layer that covers the front of the eye) or replace the natural intraocular lens with an artificial one, known as an intraocular lens (IOL). What did we want to find out? We wanted to see whether there is any difference in effectiveness and safety between the available surgical options for correcting vision at near distance (i.e. at 40 cm from the eye) and intermediate distance (i.e. at 63 to 80 cm from the eye), and whether one or other treatment leads to better well‐being for people with presbyopia. We also wanted to summarize relevant cost comparisons of the different surgical options for treating presbyopia. What did we do? We searched for studies that compared surgical options for people with presbyopia. We summarized the results reported by the studies and rated our confidence in the evidence, based on factors such as study methods and numbers of people treated. What did we find? We found four relevant studies. They were conducted in Croatia, Egypt, and Turkey, and treated 300 people (600 eyes) with presbyopia without cataracts or other problems. None of the studies included people with previous corneal or intraocular surgery. Two studies lasted for three months and two lasted for six months. One study reported that it received no funding and had no financial conflict of interest; the others did not provide this information. No study assessed the cost aspects of surgical treatments for presbyopia. Two studies compared the implantation of two different IOLs; one compared the implantation of an IOL versus corneal refractive surgery (i.e. a surgical technique that uses a laser to modify the cornea); and another compared a modified versus conventional corneal refractive surgery. Main results We could not combine the results of the four studies because each study used different treatments and reported effects at different times after surgery. In one study, people treated with corneal refractive surgery were slightly less likely to still need glasses for intermediate distances six months after surgery than those who underwent an IOL implantation. However, the people who had corneal refractive surgery were also younger, so would be expected to have less severe presbyopia, and therefore better intermediate vision. As most studies did not report the impact on well‐being, contrast sensitivity, or visual disturbances, we are uncertain about how different types of surgery affect these. There was no information about people with pseudophakic presbyopia (people whose natural lens has been replaced by an artificial lens that corrects distance vision but not close‐up vision, which is why it is known as monofocal IOL) or those with previous corneal refractive surgery. The review findings highlight the need for more research in this area regarding current surgical options and comparisons of results over longer follow‐up periods. What are the limitations of the evidence? We have little confidence in the evidence because it was unclear how studies were conducted and because we found only one relevant study for each pairwise comparison of surgical options. How up‐to‐date is this evidence? The evidence is up‐to‐date as of 29 February 2024. Summary of findings Summary of findings 1. Summary of findings table ‐ 1 ‐ Diffractive bifocal intraocular lens compared to refractive bifocal intraocular lens after refractive lens exchange for people with presbyopia. 1 ‐ Diffractive bifocal intraocular lens compared to refractive bifocal intraocular lens after refractive lens exchange for people with presbyopia Patient or population: people with presbyopia Setting: eye clinic Intervention: diffractive bifocal intraocular lens after refractive lens exchange Comparison: refractive bifocal intraocular lens after refractive lens exchange Outcomes Anticipated absolute effects * (95% CI) Relative effect
(95% CI) № of participants
(studies) Certainty of the evidence
(GRADE) Comments Risk with refractive bifocal intraocular lens after refractive lens exchange Risk with diffractive bifocal intraocular lens after refractive lens exchange Spectacle independence for near vision
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 680 per 1000 721 per 1000 (558 to 932) RR 1.06 (0.82 to 1.37) 100
(1 RCT) ⊕⊕⊝⊝
Low a, b Spectacle independence for intermediate vision
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 920 per 1000 856 per 1000 (745 to 984) RR 0.93 (0.81 to 1.07) 100
(1 RCT) ⊕⊕⊝⊝
Low a, b Change in quality of life ‐ not reported ‐ ‐ ‐ ‐ ‐ Improvement in or maintenance of binocular uncorrected distance visual acuity ‐ not reported ‐ ‐ ‐ ‐ ‐ Participant satisfaction
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 920 per 1000 1000 per 1000 (911 to 1000) RR 1.09 (0.99 to 1.19) 100
(1 RCT) ⊕⊝⊝⊝
Very low b, c Change in contrast sensitivity ‐ not reported ‐ ‐ ‐ ‐ ‐ Frequency of any ocular adverse event
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 420 per 1000 580 per 1000 (441 to 760) RR 1.38 (1.05 to 1.81) 100
(1 RCT) ⊕⊝⊝⊝
Very low b, c * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_445660938564218207 . Open in a new tab a Downgraded for risk of bias by one level because of unclear randomization process. b Downgraded for imprecision by one level because only one study was included, with a small sample size. c Downgraded for high risk of bias by two levels because of unclear randomization and unmasked outcome assessment. Summary of findings 2. Summary of findings table ‐ 2 ‐ Diffractive bifocal intraocular lens after refractive lens exchange compared to laser‐assisted in situ keratomileusis (LASIK) monovision for people with presbyopia. 2 ‐ Diffractive bifocal intraocular lens after refractive lens exchange compared to laser‐assisted in situ keratomileusis (LASIK) monovision for people with presbyopia Patient or population: people with presbyopia Setting: eye clinic Intervention: diffractive bifocal intraocular lens after refractive lens exchange Comparison: laser‐assisted in situ keratomileusis (LASIK) monovision Outcomes Anticipated absolute effects * (95% CI) Relative effect
(95% CI) № of participants
(studies) Certainty of the evidence
(GRADE) Comments Risk with laser‐assisted in situ keratomileusis (LASIK) monovision Risk with diffractive bifocal intraocular lens after refractive lens exchange Spectacle independence for near vision
assessed with: proportion (higher is favoured)
follow‐up: mean 6 months 840 per 1000 899 per 1000 (773 to 1000) RR 1.07 (0.92 to 1.25) 100
(1 RCT) ⊕⊕⊝⊝
Low a, b Spectacle independence for intermediate vision
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 1000 per 1000 820 per 1000 (720 to 940) RR 0.82 (0.72 to 0.94) 100
(1 RCT) ⊕⊕⊝⊝
Low a, b Change in quality of life ‐ not reported ‐ ‐ ‐ ‐ ‐ Improvement in or maintenance of binocular uncorrected distance visual acuity of 0.0 LogMAR units or better
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 780 per 1000 679 per 1000 (538 to 866) RR 0.87 (0.69 to 1.11) 100
(1 RCT) ⊕⊕⊝⊝
Low a, b Participant satisfaction
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 960 per 1000 941 per 1000 (854 to 1000) RR 0.98 (0.89 to 1.07) 100
(1 RCT) ⊕⊝⊝⊝
Very low b, c Change in binocular contrast sensitivity ‐ not reported ‐ ‐ ‐ ‐ ‐ Frequency of any ocular adverse event
assessed with: proportion (higher is favored)
follow‐up: mean 6 months 0 out of 50 participants presented any ocular adverse event in LASIK monovision group compared to 21 out of 50 participants in diffractive bifocal intraocular lens after refractive lens exchange group (RR 0.58 (0.46 to 0.74)) 100
(1 RCT) ⊕⊝⊝⊝
Very low b, c * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_445661404409312206 . Open in a new tab a Downgraded for risk of bias by one level because of unclear randomization. b Downgraded for imprecision by one level because only one study was included, with a small sample size. c Downgraded for high risk of bias by two levels because of unclear randomization and unmasked outcome assessment. Summary of findings 3. Summary of findings table ‐ 3 ‐ Diffractive trifocal intraocular lens compared to extended depth of focus (EDOF) intraocular lens after refractive lens exchange for people with presbyopia. 3 ‐ Diffractive trifocal intraocular lens compared to extended depth of focus (EDOF) intraocular lens after refractive lens exchange for people with presbyopia Patient or population: people with presbyopia Setting: eye clinic Intervention: diffractive trifocal intraocular lens after refractive lens exchange Comparison: extended depth of focus (EDOF) intraocular lens after refractive lens exchange Outcomes Anticipated absolute effects * (95% CI) Relative effect
(95% CI) № of participants
(studies) Certainty of the evidence
(GRADE) Comments Risk with extended depth of focus (EDOF) intraocular lens after refractive lens exchange Risk with diffractive trifocal intraocular lens after refractive lens exchange Spectacle independence for near vision ‐ not reported ‐ ‐ ‐ ‐ ‐ Spectacle independence for intermediate vision ‐ not reported ‐ ‐ ‐ ‐ ‐ Change in quality of life
assessed with: change from baseline score (higher is favored)
follow‐up: mean 3 months The mean change in quality of life was 3.69 points MD 0.08 points lower (0.15 lower to 0.01 lower) ‐ 74
(1 RCT) ⊕⊝⊝⊝
Very low a, b Improvement in or maintenance of binocular uncorrected distance in visual acuity 
assessed with: mean LogMAR (lower is favored) The mean improvement in or maintenance of binocular uncorrected distance in visual acuity was 0.05 logMAR MD 0.01 logMAR higher (0.01 lower to 0.03 higher) ‐ 74
(1 RCT) ⊕⊕⊝⊝
Low b, c Participant satisfaction ‐ not reported ‐ ‐ ‐ ‐ ‐ Change in binocular contrast sensitivity ‐ not reported ‐ ‐ ‐ ‐ ‐ Frequency of any ocular adverse event ‐ not reported ‐ ‐ ‐ ‐ ‐ * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_445939664253009002 . Open in a new tab a Downgraded for high risk of bias by two levels because of unclear randomization and unmasked outcome assessment. b Downgraded for imprecision by one level because only one study was included, with a small sample size. c Downgraded for risk of bias by one level because of unclear randomization process. Background Description of the condition We live in a three‐dimensional world; thus, the human eye must focus images on the retina from a wide range of distances [ 1 ]. The eye's ability to focus sharp retinal images at different distances by modifying its refractive power is known as accommodation. Although there are ongoing controversies about the exact mechanism of accommodation, the broadly accepted hypothesis is Helmholtz’s theory – where, as a response to the ciliary muscle contraction, the zonular tension is relieved, the lens thickness increases, and the lens diameter decreases, thus increasing its power [ 2 ]. This mechanism, in combination with a reduction in pupil diameter (miosis) and a convergent movement of both eyes in an angle of view (convergence), is known as the accommodative triad. In the young human eye, this mechanism enables individuals to have good intermediate vision (i.e. at 63 to 80 cm from the eye) and near vision (i.e. at 40 cm from the eye) [ 3 ]. Presbyopia is an age‐related refractive condition where the physiological reduction in amplitude of accommodation reaches a point in which the clarity of vision at near working distances cannot be sustained for long enough to satisfy the requirements of an individual [ 4 ]. There is no widely accepted classification of presbyopia; a recent publication suggests a severity classification based on three factors: clinical symptoms, near visual acuity (VA), and the required additional power for near correction. This additional power is expressed in diopters (D) and is considered the most direct and accurate measure of accommodative loss. Thus, mild, moderate, and advanced presbyopes require additional power of less than 1.25 D, from 1.25 to 2.0 D, and more than 2.0 D, respectively [ 3 ]. Presbyopia usually becomes noteworthy in the early to mid‐40s in emmetropes (i.e. individuals with 'normal' vision and no need for corrective lenses) and hyperopes (i.e. individuals with 'far‐sightedness' who need corrective lenses for near distances). Even though myopes (i.e. individuals with 'near‐sightedness' who need corrective lenses for far distances) may not manifest this visual impairment for near distances at similar ages due to their nearsightedness, their amplitude of accommodation also decreases with age [ 4 ]. Mild presbyopes will still retain their intermediate vision, but advanced presbyopes likely will not [ 3 ]. During recent decades, the use of digital devices has steadily increased for professional and non‐professional purposes. In the USA and Europe, an increased rate of smartphone ownership among those aged 50 or older has been reported since 2015 [ 5 ]. Moreover, quarantine due to the coronavirus disease 2019 (COVID‐19) pandemic increased screen time; thus, excellent visual acuity at intermediate and near distances has become more important in daily activities and has led to an increase in reported disorders related to eye strain, along with earlier development of presbyopia during the COVID‐19 pandemic [ 6 ]. Nearly two billion people worldwide are estimated to be affected by presbyopia [ 7 ]. With an aging population, in which the projected global median age will reach 40 years by 2050, presbyopia will be highly prevalent, irrespective of gender, ethnicity, or economic status [ 8 ]. While presbyopia manifests as difficulty reading small texts, a shortcoming in seeing near targets clearly can significantly reduce the quality of life, regardless of literacy or profession. Therefore, uncorrected presbyopia is one of the leading causes of disability, with the most significant burden in rural areas of low‐income countries [ 7 ]. Presbyopic individuals have reported a two‐fold increased difficulty in performing intermediate‐vision‐related tasks (e.g. dressing children, cooking food, lighting and adjusting a lamp, etc.) and a more than eight‐fold increased difficulty in very demanding near‐vision‐related tasks (e.g. threading a needle, sorting rice or grain, cutting fingernails, etc.), leading to a decrement in their vision‐related quality of life and productivity [ 9 ]. In 2015, the economic burden was estimated at USD 25.37 billion or 0.037% of the global gross domestic product among people under 65 years of age [ 10 ]. In 2022, an additional loss of 155 million productivity‐adjusted life years, equivalent to a total loss of USD 315 billion (a mean loss of USD 1453 per person), was predicted [ 11 ]. Presbyopia, even when corrected with spectacles for near vision, is associated with a reduced quality of life, “similar to that of treated hypertension, for the average person with the condition” [ 12 ]. Phakic presbyopes refer to “those individuals who still have a natural lens as opposed to pseudophakic presbyopia where the individual no longer has a natural lens (such as following surgery)” [ 13 ]. In this Cochrane review, we will present all references to the former situation directly as 'presbyopia', while for the latter, we will use the term 'pseudophakic presbyopia'. In a pseudophakic presbyope whose lens has been removed and a synthetic intraocular lens (IOL) has been implanted, there is a total loss of natural accommodation; therefore, the use of a monofocal IOL (i.e. that focuses at a singular point, giving a fixed refractive power with a fixed focal length) as a standard in many low‐income countries corrects distance vision but not near or intermediate vision. The per‐patient cost for spectacle use due to this postoperative refractive error in pseudophakic presbyopes was calculated for four European countries. The mean costs (2006 values) were EUR 578.90 in France, EUR 387.60 in Germany, EUR 310.50 in Italy, and EUR 230.20 in Spain [ 14 ]. Surgical approaches to correct presbyopia in individuals with monofocal IOLs have been published [ 15 , 16 , 17 , 18 ]. Clinicians should be aware of the set of differential characteristics of those individuals compared to the phakic population. Some issues stem from prior intraocular surgery itself (e.g. the presence of corneal scars and irregularities or IOL‐induced ocular aberrations) and may alter corneal refractive surgery outcomes. Furthermore, pseudophakic presbyopes are usually older, with higher rates of dry eye disease and slower healing rates; therefore, uncorrected pseudophakic presbyopia remains a challenge for ophthalmologists and patients [ 19 ]. Description of the intervention and how it might work As highlighted previously, depending on the stage, presbyopia not only affects vision at near distances but also intermediate vision [ 20 ]. A definitive correction of presbyopia should restore the true dynamic accommodation to the eye so that an accurate focus at different distances can be easily and rapidly achieved [ 4 ], with low or no latency [ 21 ]. Optical correction may be achieved through spectacles or contact lenses, with monofocal (i.e. with a single focal point) or multifocal (i.e. allowing two or more foci of vision) designs. Nevertheless, image jumping (e.g. when fixation axes cross the top edge of the bifocal area) has been associated with an increased risk of falls in elderly individuals with bifocal spectacle lenses, and proper care and hygiene are mandatory for contact lens users to avoid severe ocular surface infections [ 21 , 22 ]. These limitations and increasingly demanding visual requirements for near‐and intermediate‐vision‐related tasks have led to the development of surgical options for presbyopia correction [ 23 ]. Surgical corneal‐based procedures include refractive laser correction such as photorefractive keratectomy (PRK), laser‐assisted in situ keratomileusis (LASIK), femtosecond LASIK (FS‐LASIK), and small incision lenticule extraction (SMILE) [ 23 , 24 , 25 ]; implantation of corneal inlays [ 26 ]; and conductive keratoplasty (CK) [ 4 , 27 ]. Intraocular surgeries comprise interventions with or without lens removal [ 28 ]. Lens‐based interventions refer to clear lens removal followed by the implantation of an IOL and are known as refractive lens exchange (RLE) [ 29 , 30 ]. In terms of surgical technique, RLE and cataract surgery may be very similar, but the two procedures are performed in different patient populations. Individuals who undergo RLE are younger, have no lens opacity, and seek spectacle independence [ 31 ]. Different types of IOLs can be used: monofocal or multifocal IOLs, such as bifocal or trifocal; extended depth of focus (EDOF); small aperture; and accommodating IOLs [ 21 , 22 , 32 ]. The most vision‐threatening concern in RLE is the risk of retinal detachment, which has been reported in up to 8.1% of myopic patients [ 31 ]. On the other hand, two types of posterior chamber phakic IOLs (i.e. those designed to be implanted inside the eye between the iris and the lens) for presbyopia correction have been developed [ 33 ]: the EDOF implantable collamer lens (ICL) [ 34 ], and the presbyopic implantable phakic contact lenses (IPCL) [ 35 ]. In addition, scleral approaches have been reported. These include scleral micro‐inserts, called scleral expansion bands, and laser scleral micro‐excisions or radial sclerotomies. Despite the development of several approaches to overcome near and intermediate visual impairment, no single widely accepted classification system exists for these interventions [ 21 ]. Variation exists in both the surgically modified ocular structure and the underlying optical mechanism. Another aspect that should be considered is the progressive nature of presbyopia. Therefore, in earlier stages, the residual accommodative amplitude may be enhanced by some interventions, but in later stages, a complete restoration is needed [ 3 ]. In monovision strategies, each eye is corrected for a different distance, causing the image to be blurrier in the contralateral eye; therefore, the visual system suppresses the lower‐quality image and prefers the higher quality of two images at different distances, providing a fuller range of vision [ 36 ]. In conventional monovision, the dominant eye is fitted for distance and the non‐dominant eye for near vision, based on the hypothesis that it is easier to suppress the blur in the non‐dominant eye [ 37 ]. A monovision state can be achieved by inducing anisometropia (i.e. an imbalance in refractive power between the two eyes), leaving one eye intentionally myopic (usually to −0.50 to −2.00 D) to aid near vision and the other fully corrected for distance vision [ 24 ]. Small aperture strategies are additional approaches that aim to expand the depth of focus (i.e. the distance over which an object can be displaced and still maintained under sharp focus) in the non‐dominant eye by blocking peripheral unfocused light rays while allowing focused central light rays to reach the retina [ 38 ]. These optical modifications can be achieved following corneal or intraocular surgery [ 22 ]. Corneal procedures include laser refractive surgery to remove corneal tissue and reshape the cornea using different target refractions between the eyes; corneal inlays (i.e. small thin devices placed under lamellar flaps or into stromal pockets) implanted in the non‐dominant eye to reshape the anterior curvature, modify the refractive index or improve the depth of focus through a pin‐hole design; and CK to induce shrinkage within mid‐peripheral stroma to achieve a consequent central corneal steepening by using precise amounts of radiofrequency energy in the non‐dominant eye [ 26 , 27 ]. Unlike laser refractive surgery, implantation of corneal inlays does not remove any tissue, and is a reversible procedure. However, corneal inlays have been associated with a certain degree of haze (cloudy or opaque appearance of the cornea) and may compromise vision at night [ 32 ]. High refractive regression rates have been reported among individuals who underwent CK [ 39 ]. Overall, patient satisfaction with corneal monovision strategies has been reported to be 86% to 92.5%; they are usually implemented in mild and moderate presbyopes [ 24 ]. Intraocular surgeries for monovision include bilateral procedures with conventional monofocal IOL implantation where one eye is targeted for emmetropia and the other for a certain degree of myopia [ 22 ], and unilateral implantation of small‐apertures IOLs in the bag of phakic patients or the ciliary sulcus of pseudophakic patients [ 40 , 41 ]. The success or failure of monovision largely relies on intraocular blur suppression; if the brain cannot suppress the blurred image, a permanent and disturbing ghost image develops. Some associated disadvantages include vision impairment at intermediate distances and reduced scotopic and mesopic VA, stereopsis, and contrast sensitivity [ 4 ]. Multifocality has emerged to overcome the drawbacks of monovision. Multifocality can be achieved by performing multifocal ablation in the corneal stroma [ 23 ], or by implanting a multifocal IOL in both eyes. Multifocal corneal ablations produce multiaspheric corneal profiles (i.e. by inducing a change in the corneal asphericity from the center to the periphery) to provide an acceptable focus for distance, intermediate, and near viewing against a trade‐off of increased corneal aberrations and reduced distance vision [ 22 ]. Different algorithms have been reported that rely on whether the central or the peripheral corneal power is optimized for near vision [ 23 ]. One main concern of corneal‐based procedures is the lack of long‐term results and that further multifocal IOL implantation will be limited by having an already optically modified cornea. [ 32 ]. Bifocal or trifocal IOLs improve vision at two or more specific ranges by incorporating optics with concentric zones of different power (i.e. refractive IOL) or dividing the light into two or more focal points (i.e. diffractive IOL). EDOF IOLs have aspheric designs that include a low amount of near addition with positive spherical aberration in the central zone and negative spherical aberration in the pericentral zone to create a continuous range of focus in contrast to the biphasic or triphasic peaks of VA in bifocal or trifocal IOLs. The most frequent visual symptoms with multifocal IOLs are glare (scattered light) or halos (i.e. subjective perception of bright circles of light that surround headlights and other light sources) and reductions in contrast sensitivity. These symptoms have been reported by approximately 30% and 36% of multifocal IOL patients, respectively [ 32 ]. The ciliary muscle retains some contractility even in aged individuals [ 2 ]; thus, flexible IOLs can move forward in response to ciliary body contraction, mimicking physiologic accommodation. The optic of these accommodating IOLs is monofocal to avoid the unwanted visual side effects related to bifocal or trifocal IOLs; however, there is a limited accommodative amplitude and a high rate of posterior capsular opacification [ 30 , 31 , 42 ]. Newer phakic IOLs have been developed: the EDOF ICL, which incorporates the ICL platform with an increased optic diameter, a central port, and an aspheric design, theoretically to provide an EDOF of up to 2 D [ 34 ], and presbyopic IPCL, which incorporates a diffractive optic (i.e. using the diffraction principle) and a central opening [ 35 ]. Scleral approaches, also known as scleral expansion techniques, attempt to re‐establish the dynamic accommodation by increasing the distance between the lens equator and the ciliary body to restore the zonular tension by using scleral micro‐inserts or by scleral micro‐excisions. Scleral micro‐inserts are implants the size of a grain of rice inserted about 3000 to 4000 μm from the limbus and to a depth of 400 μm within the sclera; scleral micro‐excisions of up to 90% scleral thickness aim to create differential stiffness, increasing the compliance of scleral tissue during ciliary contraction [ 43 ]. Some risks, such as anterior segment ischemia, implant infection, endophthalmitis, and accidental scleral micro‐perforations, may be observed during the follow‐up of people who have undergone such procedures [ 22 , 32 ]. Why it is important to do this review Presbyopia is inevitable if one lives long enough, and it negatively impacts the quality of life of those affected. Despite a wide range of surgical options aimed at overcoming the effects of presbyopia, questions about the set of options with low risk and high effectiveness in different situations remain unanswered. Systematically assessing the comparative effectiveness and safety of the available surgical interventions for presbyopia would aid clinicians to individualize management recommendations while improving patients' quality of life. Furthermore, to make informed decisions about the allocation of healthcare resources, policymakers must consider the global economic impact of treating presbyopia. Therefore, evaluating the relative effectiveness and cost of different surgical options that the patient or healthcare systems may cover is crucial. Three main clinical scenarios must be considered when treating presbyopia: 1) a patient who has a clear, though dysfunctional lens and is having trouble with up‐close tasks; 2) a patient whose lens has lost transparency (to cataract development), and is suffering from a gradual loss in the quantity and quality of vision; and 3) a pseudophakic patient with monofocal IOLs who is seeking further improvement in near and intermediate vision [ 16 , 19 ]. In patients with cataracts (second scenario) for whom conservative measures (change in spectacle lens prescription) are inadequate, the only available treatment option is surgical removal of the cloudy lens material, followed by IOL implantation to replace the power of the lens. The availability of several IOL designs allows for the extra benefit of providing near or intermediate vision, or both, to correct postoperative presbyopia in patients undergoing cataract surgery; these IOLs are commonly referred to as presbyopia‐correcting IOLs [ 44 ]. The second scenario has been addressed in four Cochrane reviews [ 45 , 46 , 47 , 48 ]. Benefits and risks of interventions aimed at treating people with cataracts cannot be extrapolated to phakic patients with presbyopia and without cataracts (first scenario) or to people who have undergone surgery and had monofocal IOLs implanted to correct only distance vision (third scenario). Cataract patients undergo surgery primarily for medical reasons to restore visual acuity, whereas presbyopic individuals who choose surgery seek spectacle independence and often have higher expectations of visual quality. These differences may influence the assessment of clinical outcomes in this younger population. To the best of our knowledge, no high‐quality systematic review has been published regarding the treatment of presbyopia in phakic patients without cataracts or in pseudophakic patients with monofocal IOLs. This group of patients and their ophthalmologists are expected to benefit from our review of the comparative effectiveness and risks of different surgical strategies for correcting presbyopia. Objectives The primary objective was to evaluate the comparative effectiveness and safety of surgical interventions for people with presbyopia. The secondary objective was to produce a brief economic commentary, summarizing relevant economic evaluations that have compared different surgical interventions. Methods We followed the Methodological Expectations for Cochrane Intervention Reviews (MECIR) when conducting the review [ 49 ], and PRISMA 2020 for reporting [ 50 ]. There were no deviations from the information provided in the protocol [ 51 ]. Criteria for considering studies for this review Types of studies We included randomized controlled trials (RCTs) with at least three months of follow‐up of participants. We had planned to include quasi‐RCTs and cluster‐RCTs [ 51 ], but none of the eligible studies utilized these designs. We excluded cross‐over trials as the design does not apply to surgical interventions. We included studies regardless of their publication status or the publication language. Types of participants We included trials that enrolled participants with a diagnosis of presbyopia, including pseudophakic presbyopia (i.e. pseudophakic participant with monofocal IOL), with or without previous corneal refractive surgery. We excluded trials that had enrolled participants with other ocular comorbidities (e.g. glaucoma, diabetes mellitus, age‐related macular degeneration, or myopic retinopathy). Types of interventions We included trials in which one surgical intervention for treating presbyopia was compared to a different surgical approach or a modified version of the same intervention. We planned to include the following interventions. Laser refractive surgery (PRK, LASIK, FS‐LASIK, SMILE) Conductive keratoplasty (CK) Corneal inlays (corneal reshaping inlays, refractive inlays, and small aperture inlays) Posterior chamber phakic IOLs (such as EDOF ICL and presbyopic IPCL) RLE (with small‐aperture, EDOF, monofocal, multifocal, or accommodative IOL implantation) Scleral expansion techniques (such as scleral implants and scleral laser micro‐excision) We included trials in which interventions were performed in one or both eyes. We excluded trials that had enrolled participants mainly for cataract surgery. If any eligible trial had multiple intervention arms, we planned to list all arms of each trial in the characteristics of included studies table and only extract data from the intervention arms relevant to the current review. However, we only found two‐arm trials. Outcome measures For all the outcomes, we planned to consider 12 months after intervention as the primary time point. We categorized the follow‐up time period as short‐ (up to three months), mid‐ (between three and six months), or long‐term (more than six months) whenever outcomes at any other follow‐up time points were reported. None of the included studies reported 12‐month outcomes. Outcome data were collected at the longest time postoperatively within the same time period that was available from each study. Critical outcomes Spectacle independence for near vision (as reported by the participants). We assessed the proportion of participants who no longer needed spectacles for near‐distance activities. Spectacle independence for intermediate vision (as reported by the participants). We assessed the proportion of participants who no longer needed spectacles for intermediate‐distance activities. Change in quality of life, whether health‐related quality of life (HRQOL) or vision‐related quality of life (VRQOL), as measured with a validated questionnaire (e.g. 25‐item National Eye Institute Visual Function Questionnaire (NEI‐VFQ‐25)) and reported in numeric scores. We assessed the change in scores from baseline. Important outcomes Improvement in or maintenance of binocular uncorrected VA, including: proportion of participants who had achieved or maintained 0.2 Logarithm of the Minimum Angle of Resolution (LogMAR) units or better for near vision [ 45 ]; proportion of participants who had achieved or maintained 0.2 LogMAR units or better for intermediate vision [ 45 ]; proportion of participants who had achieved or maintained 0.0 LogMAR units or better for distance vision [ 46 ]. We also considered improvement in VA as reported by mean LogMAR value. However, when both proportions and means were available for a given trial, we prioritized proportions over means. Participant satisfaction, as determined by questionnaire, interview, visual analog scale, or any quantifiable means. We assessed the proportion of overall participant satisfaction with the surgical procedure and its results. Change in binocular contrast sensitivity (CS) [ 52 ], as measured with any validated test. We assessed the change in values from baseline. Frequency of ocular adverse events (AE), including but not limited to visual disturbance such as glare (i.e. reduced sharpness of vision under bright light, experienced when a source of light other than the main target image illuminates the retina), halos (i.e. subjective perception of bright circles of light that surround headlights and other light sources), dysphotopsias (i.e. unwanted patterns of light or shadowing on the retina), and dry eye symptoms. We compared the proportion of participants who did not experience an ocular AE. Frequency of any intervention‐related AE, including but not limited to acute intraocular pressure elevation, corneal edema, flap‐related complications, and posterior capsule rupture; as reported in the included studies. We compared the proportion of participants in each group who did not experience an intervention‐related AE. Re‐interventions/enhancements based on the proportion of participants who had required further procedures. We compared the proportion of participants in each group who had not required further procedures. Search methods for identification of studies Electronic searches To identify studies potentially eligible for inclusion in this review, the Cochrane Eyes and Vision Information Specialist searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2024, Issue 2), Ovid MEDLINE, Ovid MEDLINE E‐pub Ahead of Print, Ovid MEDLINE In‐Process and Other Non‐Indexed Citations, Ovid MEDLINE Daily (January 1946 to February 2024), Embase (January 1947 to February 2024), PubMed (1946 to February 2024), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to February 2024), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not impose any date or language restrictions on the electronic search for trials. All details of search strategies for CENTRAL, MEDLINE, Embase, PubMed, LILACS, ClinicalTrials.gov, and the WHO ICTRP are available in Supplementary material 1 . Searching other resources We checked the reference lists of studies identified as candidates for this review and any eligible systematic review to identify additional potentially relevant studies. We did not search conference proceedings for this review. We contacted the trial investigators of records to obtain information about ongoing trials. We emailed three trial investigators with our request for additional information; however, no response was received. We searched MEDLINE, Embase and Retraction Watch (retractiondatabase.org/RetractionSearch.aspx?) to ensure that none of the included studies had been withdrawn owing to errors or fraud. Data collection and analysis Selection of studies After duplicate citations were removed from the results of the searches of the electronic databases, two review authors (MJMZ, TWY) independently screened the titles and abstracts retrieved using web‐based software [ 53 ]. The review authors were not masked to the names of the authors, institutions, or journals of publication of the articles resulting from the electronic and manual searches. Each review author assessed and labeled each record as 'no (definitely exclude)', 'maybe (uncertain)', or 'yes (definitely include)'; discrepancies were resolved by a third review author (RAV). For articles not published in English, Spanish, Italian, Portuguese, or French languages, we obtained English translations of relevant abstracts and, where necessary, full‐text articles before making the final decision. Two review authors (EHQ, EDG) independently assessed the full‐text copies of all potentially eligible studies (those classified as 'include' and 'uncertain' in the first step) against the eligibility criteria. We resolved discrepancies through discussion or by consulting a third review author (CLM). We excluded all irrelevant citations from the review but report the number of excluded studies in a flow chart diagram with reasons for exclusion [ 50 ]. When we required clarification to determine trial eligibility, we contacted the authors of the trial. All excluded studies, together with a brief justification for exclusion, are listed in Supplementary material 3 . For potentially eligible studies identified from trial registers, we planned to act as follows. For any trial that had a completion date of more than two years before our search date, we searched for publications from the trial and contacted the trial investigators to obtain published or unpublished data from the trial. Whenever the trial investigators did not respond, we documented the trial in the 'Awaiting classification' section. For any trial that had a completion date within two years of our search date or in the future, we documented the trial in the 'Ongoing studies' section. Data extraction and management Two review authors (RAV, MJMZ) independently extracted data from reports from the included studies using an online data extraction form developed in Covidence by the CEV US Project (CEV@US) [ 53 ]. Whenever multiple reports from the same trial were identified, we merged these reports in order to extract and analyze data at the trial level. This form was piloted in advance. Discrepancies were resolved by discussion. We contacted trial investigators for missing data or information clarification. One review author imported all data directly to RevMan [ 54 ]; a second author verified the accuracy of the imported data. We extracted the following data from each included trial. Trial characteristics: title, author name, funding, and support. Methods: trial design, total duration of trial, number of trial centers and location, trial setting, and date of trial; how eyes were handled in the design and analysis. When a trial had included one eye per participant as the trial eye, how that eye had been selected (e.g. better/ worse, randomly, right/left). Whenever a trial had included both eyes as study eyes, how data from both eyes had been analyzed (e.g. average, accounting for correlation between eyes, parallel group). Participants: number (participants/eyes), intervention allocation method (randomized or quasi‐randomized), number lost to follow‐up/withdrawn, number analyzed, mean age, age range, gender, refractive error, near additional power, diagnostic criteria, manifest refractive error spherical equivalent, inclusion criteria, and exclusion criteria. Interventions: test intervention and comparator. Outcomes: outcomes specified and measured, and time points at which they were reported. We extracted the outcome data separately for the test intervention and comparator groups. Notable potential conflicts of interest of report authors, trial registration number, any notable features of the trial. Economic data such as the analytic framework (trial‐ or model‐based) and type (cost analysis, cost‐effectiveness analysis, cost‐utility analysis, cost‐benefit analysis) of economic evaluation; the analytic perspective (costs and benefits a decision maker views as important); time horizon (the duration over which costs and effects were assessed) adopted; the main cost items included in each analysis (e.g. by category such as health sector costs, other sector costs, patient and family costs and productivity impacts, hospital care costs, direct health care costs; indirect non‐healthcare costs); and the setting (i.e. country in which the trial was performed), currency and price year used in each analysis, when available. We did not exclude any trials solely based on reporting of the desired outcome. Where a published report did not include the outcomes targeted for this review, we accessed the trial protocol when available, and contacted the authors of trial reports to ascertain whether the desired outcomes had been measured but not reported. We included in the narrative of the review findings any otherwise eligible trials in which outcomes had been measured but not reported, or which had not reported the data in the desired format. Risk of bias assessment in included studies For each outcome presented in the summary of findings tables, two review authors (RAV, MJMZ) independently assessed the risk of bias for each included trial that had reported the outcome using the Cochrane Risk of Bias 2 (RoB 2) tool, detailed in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions [ 55 ]. We resolved any disagreements for which consensus could not be reached by consulting a third review author (TWY). We assessed the risk of bias in each of the following five domains: 1. bias arising from the randomization process; 2. bias due to deviations from intended interventions; 3. bias due to missing outcome data; 4. bias in the measurement of the outcome; and 5. bias in the selection of the reported result [ 56 ]. We judged each domain to be at ‘low risk of bias’, ‘some concerns’, or ‘high risk of bias’. Whenever the risk of bias was unclear due to lack of information or uncertainty of the potential for bias, we contacted trial investigators for clarification. We used the available data in the published report when we did not receive a response within four weeks. We assigned an overall risk of bias judgment for each trial by assessing the risk of bias across all five domains for each outcome of interest, answering signaling questions (with ‘yes’, ‘probably yes’, ‘probably no’, ‘no’, or ‘no information’) using the Excel tool available on www.riskofbias.info. We considered the risk of bias for each trial as follows. Low risk of bias – when we deemed all domains for the outcome to be at low risk of bias. Some concerns – when we had some concerns about at least one domain for this outcome, and we judged none of the domains to be at high risk of bias. High risk of bias – when we judged at least one domain to be at high risk of bias, or we had some concerns about multiple domains in a way that substantially lowered confidence in the outcome data. We summarized the overall risk of bias for each outcome as the least favorable assessment across the bias domain. Measures of treatment effect We were interested in quantifying the effect of assignment to the interventions at baseline, regardless of whether the interventions were received as intended (the 'intention‐to‐treat effect') [ 57 ]. We expressed dichotomous outcomes (e.g. spectacle independence, AE) in terms of risk ratios (RRs) with 95% confidence intervals (CIs) [ 58 ]. We presented continuous outcomes (e.g. quality of life), where possible, on the original scale as reported in each trial by mean change from baseline with its associated standard deviation (SD), ensuring that all scales measured the effect in the same direction. When data were not reported in a format that we could enter directly into a meta‐analysis, we converted them to the required format using the information in Chapter 6 of the Cochrane Handbook for Systematic Reviews of Interventions [ 59 ]. When data from outcomes measured using questionnaires, such as quality of life, were reported item by item instead of a total score, we pooled item scores to obtain an overall score. As part of our plan to report VA in LogMAR units, we converted data from various scales, including decimal or Snellen fractions, as needed [ 60 ]. We planned to present data as mean difference (MD) or standardized mean difference (SMD) with 95% CIs in anticipation of using different measuring instruments; however, we did not use SMD because only one study presented data per analysis. Unit of analysis issues The participant was the primary unit of analysis for critical outcomes (spectacle independence and quality of life) and some important outcomes (binocular uncorrected VA and participant satisfaction) [ 61 ]. Therefore, for trials with parallel designs (participants randomly allocated to interventions) and only two arms (intervention 1 versus control or intervention 1 versus intervention 2), and where the outcome was measured at the person‐level (e.g. quality of life), no unit of analysis issue existed. Within‐person trials in which the two eyes had been allocated to different interventions could not provide these outcomes. For the remaining important outcomes, such as change in contrast sensitivity, ocular AE, and re‐intervention/enhancement, which are usually measured at the level of the eye, whenever both eyes had been allocated to the same treatment group (two‐eye design) or different treatment groups (paired‐eye design), we extracted the results that had accounted for correlation of outcomes between eyes. For visual acuity and contrast sensitivity measurements, we prioritized binocular over monocular data. We followed the recommendations from Chapter 23 of the Cochrane Handbook for Systematic Reviews of Interventions [ 62 ]. Each of the included studies reported a single pair‐wise comparison of interventions. If we had found trials with repeated measurements, we would have analyzed and reported outcomes based on different follow‐up periods. [ 59 ]. Dealing with missing data We analyzed outcomes on an intention‐to‐treat basis. We contacted the investigators to verify key trial characteristics or to obtain missing outcome data or additional information that we desired; whenever no response was received within four weeks, we used the published data and imputed missing SDs or other necessary data by borrowing information from the trial, such as CIs, based on methods outlined in Chapter 6 of the Cochrane Handbook for Systematic Reviews of Interventions [ 59 ]. Because of the small number of included studies, we did not perform any sensitivity analyses. Reporting bias assessment We assessed selective or incomplete reporting for each trial by comparing the outcomes specified in a protocol or clinical trial registry with those reported from the trial. When protocols or clinical trial registry records were unavailable, we assessed selective outcome reporting based on comparison of the outcomes specified in the methods section of each trial report and outcomes reported from the trial. We did not construct funnel plots because of the small number of included studies [ 63 ]. Synthesis methods Two review authors analyzed data in RevMan [ 54 ], following Chapter 10 of the Cochrane Handbook for Systematic Reviews of Interventions [ 58 ]. Meta‐analysis of numerical data We were unable to perform meta‐analysis of any outcome due to an insufficient number of studies that had compared similar interventions. Synthesis using other methods In the event of inconsistency between individual trial methodologies or trial results such that a combined result may not be a good summary of the individual trial results – for example, the effects were in different directions or I² was more than 75% and the P value less than 0.1 – we had planned to not combine the data. Instead, we had planned to describe the pattern of the individual trial results, following the recommended methods from Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions to synthesize results without meta‐analysis (SWiM) [ 64 ]. We were unable to perform a quantitative synthesis due to substantial clinical heterogeneity and the small number of studies included. Thus, we provide a narrative synthesis. Brief economic commentary We had planned to develop a brief economic commentary to summarize the available data of full economic evaluations (i.e. cost‐effectiveness analysis, cost‐utility analysis, and cost‐benefit analysis) that had compared the costs and effects of two or more surgical approaches to correct presbyopia [ 65 ]. However, no included study reported analysis of the economic aspects of surgical interventions. Heterogeneity We had planned to evaluate clinical, methodological, and statistical heterogeneity across the studies to determine whether they were similar enough to allow for the pooling of trial results [ 58 ]. We did not pool the outcome data from included studies because each included study had compared a different pair of interventions; therefore, statistical heterogeneity was not relevant. Investigation of heterogeneity and subgroup analysis If there had been a sufficient number of included studies (n ≥ 3) per available group, we would have performed subgroup analysis to investigate the reasons for any clinical or statistical heterogeneity. We would have compared the effect of the intervention on critical outcomes by the following subgroups. Type of ametropia (emmetropia, hyperopia, and myopia) Lens status ('phakic' presbyopia and pseudophakic presbyopia) Length of follow‐up after surgery (short‐term: up to three months, mid‐term: between three and six months, and long‐term: more than six months). We did not perform subgroup analysis because there was only one study in each pairwise comparison of intervention. Equity‐related assessment In this review, we did not investigate health inequity. Sensitivity analysis If sufficient data had been available (n ≥ 3 studies per analysis), we planned to perform a sensitivity analysis to explore the robustness of comparative effect estimates and the influence of exclusion of studies at an overall high risk of bias on the estimated effect sizes for the critical outcomes [ 66 ]. However, we did not perform a sensitivity analysis due to the insufficient number of included studies. Certainty of the evidence assessment We prepared summary of findings tables presenting absolute risk and RRs, with an assessment of the overall certainty of the evidence [ 67 ]. Two review authors (RAV, MJMZ) independently assessed the certainty of the body of evidence for each outcome as one of four levels (high, moderate, low, or very low) using GRADEpro software [ 68 , 69 ]. We resolved disagreements by discussion to obtain consensus within the review team. We downgraded the certainty of the body of evidence available for an outcome whenever we identified any of the following issues. Overall high risk of bias among included studies Indirectness of evidence Unexplained heterogeneity or inconsistency of results Imprecision of results (i.e. wide CIs) High likelihood of publication bias We included the following outcomes in the summary of findings tables for the primary time point of three to six months' follow‐up. Spectacle independence for near vision. We report the proportion of participants who no longer needed spectacles for near‐distance activities. Spectacle independence for intermediate vision. We report the proportion of participants who no longer needed spectacles for intermediate‐distance activities. Change in quality of life (such as HRQOL or VRQOL), measured with any validated questionnaires and reported in numeric scores. We report the change in the scores from the baseline. Improvement in or maintenance of binocular uncorrected distance VA of 0.0 LogMAR units or better. Participant satisfaction, as determined by questionnaire, interview, visual analog scale, or any quantifiable means. We report the proportion of overall participant satisfaction with the assigned procedure and its results. Change in binocular contrast sensitivity, as measured with any validated test. Frequency of any ocular AE, including but not limited to visual disturbances such as glare and halos, dysphotopsias, and dry eye symptoms. We compared the proportion of participants in each group who did not experience ocular AEs. We prioritized the surgical techniques most performed in clinical practice as the most important comparisons to be included in the summary of findings tables, as follows. The implantation of different types of IOLs after RLE IOL implantation versus corneal refractive surgery Different corneal refractive surgical techniques Consumer involvement No consumers were involved in this review. Results Description of studies Results of the search Our searches of the electronic databases in February 2024 yielded 13064 records. After duplicates had been removed, we screened 7496 titles and abstracts ( Figure ). We retrieved 33 full‐text reports for further screening and excluded 23 studies (25 records), for reasons reported in Supplementary material 3 . We included four completed studies (Barišić 2008 [ 70 ]; Barišić 2010 [ 71 ]; Khalifa 2011 [ 72 ]; Ozulken 2021 [ 73 ]), identified one ongoing study ( NCT04617080 [ 74 ]), and listed three studies as awaiting classification (Belmont 2007 [ 75 ]; Bohorquez 2008 [ 76 ]; NCT04156737 [ 77 ]) in this review. 1. Open in a new tab Study flow diagram Included studies Table summarizes salient features of the four included studies. We provide comprehensive descriptions of the studies included in this review in Supplementary material 2 . 1. Overview of included studies and syntheses. Study ID Study design (follow‐up) Setting Intervention Comparison Number randomized Population (mean age (SD)/ % male) Outcomes with available data Barišić 2008 Parallel‐group RCT (6 months) Svjetlost Eye Clinic in Croatia Diffractive bifocal IOL Refractive bifocal IOL 100 54 (3.3) / 42 1. Spectacle independence for near vision 2. Spectacle independence for intermediate vision 3. Patient satisfaction 4. Frequency of any ocular AE 5. Frequency of any intervention‐related AE 6. Proportion of participants who required further procedures Barišić 2010 Parallel‐group RCT (6 months) Svjetlost Eye Clinic in Croatia Diffractive bifocal IOL LASIK monovision 100 50 (3.8) / 34 1. Spectacle independence for near vision 2. Spectacle independence for intermediate vision 3. Proportion of participants with 0.2 LogMAR or better for near vision 4. Proportion of participants with 0.0 LogMAR or better for distance vision 5. Proportion of overall patient satisfaction with the procedure and its results 6. Frequency of any intervention‐related AE Khalifa 2011 Parallel‐group RCT (3 months) Horus Vision Correction Center in Egypt Conventional wavefront‐guided LASIK Modified wavefront‐guided LASIK 26 46.5 / 34.6 No outcomes related to the review Ozulken 2021 Parallel‐group RCT (3 months) Ophthalmology Department in Turkey Diffractive trifocal IOL EDOF IOL 74 57.6 (5.5) / 58.1 1. Change in quality of life 2. Mean binocular uncorrected near visual acuity (LogMAR) 3. Mean binocular uncorrected intermediate visual acuity (LogMAR) 4. Mean binocular uncorrected distance visual acuity (LogMAR) 5. Frequency of any intervention‐related AE 6. Proportion of participants that required further procedures AE : Adverse Event; EDOF : extended depth of focus; IOL : intraocular lens; LASIK : Laser‐Assisted In Situ Keratomileusis; RCT : randomized controlled trial; SD : standard deviation Open in a new tab Types of studies All four included studies were single‐center parallel‐group randomized controlled trials (RCTs). Three studies compared a surgical intervention for presbyopia with a different surgical intervention (Barišić 2008; Barišić 2010; Ozulken 2021), and one study compared a surgical intervention with a modified version of the same intervention (Khalifa 2011). Two trials were conducted in Croatia (Barišić 2008; Barišić 2010), one in Egypt (Khalifa 2011), and one in Turkey (Ozulken 2021). Three trials were published between 2008 and 2011, and one was published in 2021. None of the trials were registered with ICTRP or ClinicalTrials.gov or reported registration elsewhere. No study specified the period during which the trial was conducted. One trial stated that no funding had been received and no financial conflict of interest existed (Ozulken 2021); none of the other three trials reported any funding source or declaration of interest. Follow‐up duration ranged from three months (Khalifa 2011; Ozulken 2021) to six months (Barišić 2008; Barišić 2010) after surgery. None of the trials reported outcomes at 12 months postoperatively. All the included studies randomized participants and assigned both eyes of each participant to the same intervention. Types of participants The four included studies enrolled a total of 300 participants (600 eyes), with mean ages ranging from 46 to 58 years. In total, 57% of the enrolled participants were women (range: 42% to 66%). All enrolled participants had presbyopia and no other comorbidities such as cataracts, glaucoma, diabetes mellitus, age‐related macular degeneration, or myopic retinopathy. All the studies included participants who were highly motivated for spectacle independence. Three studies included participants with up to 1.0 D of astigmatism (Barišić 2008; Barišić 2010; Ozulken 2021), while one study specified having a total coma aberration of > 0.2 µm at 6.00 mm pupil diameter as one of the inclusion criteria (Khalifa 2011). None of the included studies reported the near addition on refraction (i.e. the additional optical correction needed to focus at a close distance, which is related to the degree of presbyopia), but one study reported the manifest refractive spherical equivalent (Khalifa 2011). None of the studies included participants who had pseudophakic presbyopia or had undergone previous refractive corneal surgery. Types of interventions Two studies aimed to compare the implantation of two different intraocular lenses (IOLs) after refractive lens exchange (RLE); of these, one study compared the implantation of diffractive bifocal IOL versus refractive bifocal IOL (Barišić 2008), and the other compared the implantation of diffractive trifocal IOL against extended depth of focus (EDOF) IOL (Ozulken 2021). Another study compared implantation of diffractive bifocal IOL after RLE with laser‐assisted in situ keratomileusis (LASIK) using a monovision approach (Barišić 2010); the fourth study compared modified wavefront‐guided (WG) LASIK with conventional WG LASIK (Khalifa 2011). Types of outcomes Critical outcomes Two studies reported spectacle independence as the proportion of participants who no longer needed spectacles for near‐distance and intermediate‐distance activities at six months after surgery (Barišić 2008; Barišić 2010). Only one study reported a change in quality of life (QoL) from baseline to three months (Ozulken 2021). Important outcomes Three studies reported improvements in binocular visual acuity (VA) (Barišić 2010; Khalifa 2011; Ozulken 2021). In one study, the improvement was reported as the proportion of participants who had achieved 0.2 LogMAR or better for near and distance vision at six months (Barišić 2010). The other two studies evaluated vision improvement as the mean binocular uncorrected near and distance VA (Khalifa 2011; Ozulken 2021); Ozulken 2021 additionally reported intermediate VA. Two studies reported the proportion of participants who reported overall satisfaction with the surgical procedure and its results (Barišić 2008; Barišić 2010). A single study provided the change from baseline in binocular contrast sensitivity (CS) (Khalifa 2011). Two studies each reported the frequency of any ocular adverse event (AE) (Barišić 2008; Barišić 2010), the frequency of any intervention‐related AE (Barišić 2008; Ozulken 2021), and the proportion of participants who required re‐intervention/ enhancement (Barišić 2008; Ozulken 2021). Excluded studies After evaluating the full‐text reports or trial registry records, we excluded 21 studies. Twelve studies did not enroll the population of interest; seven had an ineligible study design, and two did not compare two different surgical approaches or a surgical approach with a modified version of the same intervention. Detailed reasons for exclusion are shown in Supplementary material 3 . Ongoing studies and studies awaiting classification We have identified one registered ongoing study; detailed information is provided in Supplementary material 5 . We assigned two studies and two trials as awaiting classification because they did not clearly mention the patient population or because no published results were available two years or more since the completion of the trial. Detailed information is available in Supplementary material 4 . Risk of bias in included studies We applied the risk of bias 2 tool (RoB 2) to assess the included studies for potential bias in measuring and reporting the seven prespecified outcomes. Our judgments regarding RoB are summarized in Figure . The complete risk of bias assessments and support for judgments are provided in Supplementary material 6 and Supplementary material 9 . Full consensus decisions for the signaling questions of each domain across all studies are available via the Open Science Framework (OSF) [ 78 ]. 2. Open in a new tab RoB 2 summary: all outcomes presented in summary of findings table We judged two studies to be subject to some concerns regarding the overall risk of bias in ‘spectacle independence for near vision’ and ‘spectacle independence for intermediate vision’ (Barišić 2008; Barišić 2010). With respect to ‘change in quality of life’, we judged one study to have a high risk of bias (Ozulken 2021). We also deemed one study to have a high risk of bias regarding the outcome 'improvement in binocular uncorrected distance VA' (Ozulken 2021), while two studies raised some concerns of bias for the same outcome (Barišić 2010; Khalifa 2011). We considered ‘participant satisfaction’ to have a high risk of bias in two studies (Barišić 2008; Barišić 2010). We also had some concerns about potential bias for the outcome ‘change from baseline in contrast sensitivity’ in one study (Khalifa 2011). Regarding the ‘frequency of any ocular AE’, we assessed two studies to have a high risk of bias (Barišić 2008; Barišić 2010). Bias arising from the randomization process We judged all included studies to raise some concerns of bias for all outcomes in this domain. All included studies stated that the study was randomized, but none provided details of the randomization process. In one study, participants in one intervention group were older than those in the other (Barišić 2010); given that presbyopia is a progressive age‐related disorder, the severity of the disorder is expected to vary among age groups. Bias due to deviations from intended interventions We judged all studies to be at low risk of bias in this domain for all outcomes reported. None of the studies specified the analysis method, but all randomized participants were included in analyses. Khalifa 2011 was reported to be a double‐masked study with both outcome observers and participants masked to the intervention; the other studies did not report whether any masking procedure had been implemented. However, in our opinion, unmasking is unlikely to have led to deviations from the intended surgical interventions by either the surgeons or the participants. Bias due to missing outcome data We judged all studies to be at low risk of bias for all outcomes in this domain. Outcome data were available for all randomized participants for all outcomes reported by each included study. Bias in the measurement of the outcome Spectacle independence for near vision and spectacle independence for intermediate vision Two studies reported these participant‐assessed outcomes (Barišić 2008; Barišić 2010); we judged them both to have a low risk of bias within this domain for these two outcomes. Although the studies did not provide information on the implementation of masking, it was unlikely that the assessment of these outcomes was influenced by knowledge of the intervention received. Change in quality of life We considered the assessment of change in quality of life in Ozulken 2021 to have a high risk of bias. Although the outcome was measured using a validated tool, the National Eye Institute Visual Function Questionnaire‐14 (VF‐14 QOL), and the study report stated that “special care was taken not to influence the patients”, the surgeon administered the questionnaire through face‐to‐face interviews; therefore, the responses could have been influenced by the participant's and surgeon's knowledge of the assigned intervention. Improvement in or maintenance of binocular uncorrected distance VA We judged Ozulken 2021 to have a high risk of bias because appointments were scheduled at the surgeon's discretion, and visual acuity was measured based on clinical indications. We judged Barišić 2010 to have some concerns of bias due to the subjective nature of visual acuity measurement and to the different postoperative clinical appearances of the two interventions in the setting of an unmasked study. We considered Khalifa 2011 to be at low risk of bias in this domain. Participant satisfaction We judged two studies to have a high risk of bias because the results of self‐reported participant satisfaction could have been influenced by knowledge of the intervention assigned (Barišić 2008; Barišić 2010). Change in binocular contrast sensitivity We judged Khalifa 2011 to have a low risk of bias because the postoperative follow‐up appointments were double‐masked for both outcome assessors and participants. Frequency of any ocular AE We judged two studies to have a high risk of bias because there was no information on the use of structured questionnaires or validated tools to capture AEs. The results could also have been influenced by unmasked participants or trial personnel (Barišić 2008; Barišić 2010). Bias in selective results reporting We judged all studies to have a low risk of bias in this domain because all outcomes measured were reported except for 'change in quality of life'. We judged Ozulken 2021 as having a high risk of bias for change in quality of life because no protocol was available, and the study did not follow the conventional scoring of VF‐14 QOL responses. Synthesis of results A comprehensive set of comparisons and analyses is available in Supplementary material 7 , while the complete data package is accessible in Supplementary material 8 . Table ; Table ; and Table present summaries of both absolute and relative effects for prespecified outcomes, along with their GRADE ratings to indicate the certainty of evidence available for effect estimates. We included four studies, each of which compared a different pair of surgical interventions. No study was found that had reported any desired outcome at 12 months. Three of the four included studies contributed data for estimation of effects and confidence intervals at three months or six months after surgical intervention (Barišić 2008; Barišić 2010; Ozulken 2021). Comparison 1: Diffractive bifocal IOL versus refractive bifocal IOL after RLE Only Barišić 2008 compared the implantation of these two different multifocal IOLs after RLE in participants with presbyopia. Critical outcomes Spectacle independence for near vision Barišić 2008 reported this outcome at six months. In the diffractive bifocal IOL group, 72% of participants achieved spectacle independence for near vision, compared to 68% in the refractive bifocal IOL group. The single‐trial estimate indicated that diffractive bifocal IOL implantation after RLE showed no evidence of a benefit in the proportion of participants who no longer needed spectacles for near‐distance activities compared with the implantation of refractive bifocal IOL (risk ratio [RR] 1.06, 95% confidence interval [CI] 0.82 to 1.37; 100 participants; Analysis 1.1) We downgraded the certainty of the evidence to low because of the risk of bias (‐1) due to an unclear randomization process, and imprecision (‐1) due to only including one study, with a small sample size. Spectacle independence for intermediate vision Barišić 2008 also reported the proportion of participants who no longer needed spectacles for intermediate‐distance activities at six months. In the diffractive bifocal IOL group, seven participants experienced difficulties with computer work and required spectacles, whereas in the refractive bifocal IOL group, four participants needed spectacles for computer use. The single‐trial estimate indicated no evidence of a difference in spectacle independence for intermediate vision when comparing refractive bifocal IOL implantation with the diffractive one after RLE (RR 0.93, 95% CI 0.81 to 1.07; 100 participants; Analysis 1.2). We downgraded the certainty of evidence to low because of the risk of bias (‐1) due to an unclear randomization process, and imprecision (‐1) due to only one study being included, with a small sample size. Change in quality of life The only trial included in this comparison of interventions did not report this outcome. Important outcomes The only trial included in this comparison did not report improvement in binocular uncorrected VA or change from baseline in contrast sensitivity. Participant satisfaction Barišić 2008 reported that all participants in the diffractive bifocal IOL group would choose to implant the same lens again, whereas four participants randomized to the refractive bifocal IOL group stated they would not opt for the same lens again. Based on data provided by Barišić 2008, participants who underwent diffractive bifocal IOL implantations had no higher satisfaction rates than those treated with refractive bifocal IOL after RLE (RR 1.09, 95% CI 0.99 to 1.19; 100 participants; Analysis 1.3). We rated the certainty of the evidence as very low due to a high risk of bias (‐2), stemming from an unclear randomization process and a lack of blinding in outcome assessment, as well as imprecision (‐1), as only one study with a small sample size was included. Frequency of any ocular AE Barišić 2008 reported a lower proportion of participants who had complained of mild to moderate visual disturbances when driving at night in the diffractive bifocal IOL arm at six months (RR [non‐event] 1.38, 95% CI 1.05 to 1.81; 100 participants; Analysis 1.4). However, the certainty of evidence was very low due to high risk of bias (‐2) and imprecision (‐1). Therefore, we cannot conclude that diffractive bifocal IOL implantation reduced the frequency of ocular AE compared to refractive bifocal IOL implantation after RLE. Frequency of any intervention‐related AE No intraoperative or postoperative intervention‐related AE was reported by six months of follow‐up in Barišić 2008 for participants in either intervention arm. Proportion of participants who required further procedures At six months postoperative, Barišić 2008 reported that two participants in the refractive bifocal IOL implantation arm but none in the diffractive IOL arm required secondary surgery to explant the multifocal IOL and replace it with a monofocal one. The point estimate indicated that the diffractive bifocal IOL implantation had resulted in little to no difference in the proportion of participants that required further procedures compared with refractive bifocal IOL(RR [non‐event] 1.04, 95% CI 0.97 to 1.11; 100 participants; Analysis 1.5). Comparison 2: Diffractive bifocal IOL after RLE versus LASIK monovision Only Barišić 2010 randomized participants with presbyopia to be treated with intraocular surgery (diffractive bifocal IOL implantation after RLE) or with refractive corneal surgery (LASIK with monovision approach). Critical outcomes Spectacle independence for near vision Barišić 2010 reported this outcome at six months postoperatively. In the diffractive bifocal IOL group, 90% of participants achieved spectacle independence for near vision, compared to 84% in the LASIK monovision group. The single‐trial estimate showed no evidence of a difference in the proportion of participants who no longer needed spectacles for near‐distance activities between the implantation of diffractive bifocal IOL after RLE and LASIK monovision (RR 1.07, 95% CI 0.92 to 1.25; 100 participants; Analysis 2.1). We judged the certainty of evidence as low due to the risk of bias (‐1) arising from an unclear randomization process, and imprecision (‐1) due to only one study being included, with a small sample size. Spectacle independence for intermediate vision Barišić 2010 reported data on the proportion of participants who no longer needed spectacles for intermediate‐distance activities at six months. None of the participants in the LASIK monovision group reported complaints regarding intermediate vision, whereas 18% of participants in the diffractive bifocal IOL group reported difficulties with computer work. LASIK monovision led to a larger proportion of participants with spectacle independence for intermediate vision compared with diffractive bifocal IOL implantation (RR 0.82, 95% CI 0.72 to 0.94; 100 participants; Analysis 2.2). We judged the certainty of evidence as low because of the risk of bias (‐1) due to an unclear randomization process, and imprecision (‐1) due to only one study being included, with a small sample size. Change in quality of life The only trial included in this comparison of surgical interventions did not report this outcome. Important outcomes The only trial included in this comparison of interventions did not report the important outcomes of improvement from baseline in contrast sensitivity, frequency of any intervention‐related AE, or proportion of participants who required further procedures. Improvement in or maintenance of binocular uncorrected VA An improvement in binocular uncorrected VA was reported for both near and distance vision in the two groups. LASIK monovision was not inferior to implantation of diffractive IOL after RLE in the proportion of participants achieving or maintaining 0.0 LogMAR or better for distance vision (RR 0.87, 95% CI 0.69 to 1.11; 100 participants; Analysis 2.3). On the other hand, when comparing the proportion of participants who achieved 0.2 LogMAR or better for uncorrected near vision at six months, Barišić 2010 reported slightly higher rates in the diffractive bifocal IOL compared with LASIK monovision (RR 1.21, 95% CI 1.02 to 1.42; 100 participants; Analysis 2.4). We downgraded the certainty of evidence to low because of the risk of bias (‐1) due to an unclear randomization process, and imprecision (‐1) due to only one study being included, with a small sample size. Participant satisfaction Barišić 2010 reported high participant satisfaction with surgical intervention and outcomes in both groups at six months postoperative. The single estimate indicated no evidence of a difference in improving participant satisfaction when comparing diffractive bifocal IOL implantation with LASIK monovision (RR 0.98, 95% CI 0.89 to 1.07; 100 participants; Analysis 2.5). We downgraded the certainty of evidence to very low because of the high risk of bias (‐2) due to an unclear randomization process and lack of blinding in outcome assessment, and imprecision (‐1) due to only one study being included, with a small sample size. Frequency of any ocular AE Barišić 2010 reported that 21 participants randomized to diffractive bifocal IOL implantation, but none assigned to LASIK monovision, complained about mild to severe problems with halos and glare. We compared the proportions of participants who were free of any AE (RR [non‐event] 0.58, 95% CI 0.46 to 0.74; 100 participants; Analysis 2.6) at six months of follow‐up. However, the certainty of the evidence was very low because of the high risk of bias (‐2) due to an unclear randomization process and lack of blinding in outcome assessment, and imprecision (‐1) due to only one study being included, with a small sample size. Comparison 3: Diffractive trifocal IOL versus extended depth of focus (EDOF) IOL after RLE Only one study compared implantation of diffractive trifocal IOL versus EDOF IOL implantation after RLE in participants with presbyopia (Ozulken 2021). Critical outcomes The only trial included in this comparison did not report the critical outcomes of spectacle independence for near or intermediate vision. Change in quality of life Ozulken 2021 reported data on vision‐related quality of life at three months as measured by the VF‐14 QOL; however, no baseline data were reported. This single effect estimate for quality of life indicated no clinically meaningful difference at three months between EDOF IOL and diffractive trifocal IOL (mean difference [MD] ‐0.08, 95% CI ‐0.15 to ‐0.01; 74 participants; Analysis 3.1). We downgraded the certainty of evidence to very low because of a high risk of bias (‐2) due to an unclear randomization process and lack of blinding in outcome assessment, and imprecision (‐1) due to only one study being included, with a small sample size. Important outcomes The only trial included in this comparison did not report the important outcomes of participant satisfaction, change from baseline in contrast sensitivity, or frequency of ocular AEs. Improvement in or maintenance of binocular uncorrected VA Ozulken 2021 reported an improvement in uncorrected binocular VA for near, intermediate, and far distances at three months compared to baseline in both groups. The single‐trial estimate indicated no evidence of a difference between intervention arms in improvement in binocular uncorrected near VA (MD 0.01, 95% CI ‐0.02 to 0.04; 74 participants), intermediate VA (MD 0.01, 95% CI ‐0.01 to 0.03; 74 participants) or distance VA (MD 0.01, 95% CI ‐0.01 to 0.03; 74 participants) when diffractive trifocal IOL was compared with EDOF IOL implantation after RLE (Analysis 3.2). We downgraded the certainty of the evidence for all three outcomes to low due to a high risk of bias (‐1) arising from an unclear randomization process and imprecision (‐1), as only one study with a small sample size was included. Frequency of intervention‐related AE and proportion of participants that required further procedures. No AE related to the procedure or need for further surgery was reported in either intervention arm up to three months of participant follow‐up (Ozulken 2021). Comparison 4: Modified wavefront‐guided (WG) LASIK versus conventional WG LASIK Only one study reported outcomes that compared WG LASIK with a modified version of the same intervention in participants with presbyopia (Khalifa 2011). Critical outcomes The only trial included in this comparison did not report any critical outcomes. Important outcomes The only trial included in this comparison did not report the important outcomes of participant satisfaction, frequency of any AE, and the proportion of participants who required further procedures. Improvement in or maintenance of binocular uncorrected VA Khalifa 2011 provided data for this comparison at three months; however, it could not be included in the quantitative analysis of uncorrected binocular VA due to the reporting format. The unit of analysis used in Khalifa 2011 was the eye, but inter‐eye correlation was not considered; additionally, there was insufficient reporting of descriptive statistics (means and standard deviations) necessary for computing treatment effect estimates. Khalifa 2011 reported that uncorrected distance VA “significantly improved” in all cases with no difference between groups and that uncorrected near vision in the modified WG LASIK arm was significantly better than in the conventional WG LASIK arm. Change from baseline in binocular contrast sensitivity Khalifa 2011 measured change in CS and compared modified with conventional WG LASIK but did not present data in a way that could be analyzed quantitatively. At three months, Khalifa 2011 reported that “contrast sensitivity significantly improved in both groups after the procedure, and no significant intergroup differences were detected”. Equity assessment We did not investigate health inequity in this review. Reporting biases Although none of the trials were registered on the trial registries we searched, or reported any publicly available protocols or registration records, the outcomes reported corresponded to all intended outcome measurements described in the methods sections in reports from all studies. We judged three studies to have a low risk of reporting bias in all outcomes; Ozulken 2021 reported data regarding change in QoL but did not follow the conventional scoring of the VF‐QOL questionnaire used. Discussion Summary of main results We identified four eligible randomized controlled trials (RCTs) (Barišić 2008; Barišić 2010; Khalifa 2011; Ozulken 2021), which enrolled a total of 300 participants with presbyopia, as defined by the study authors, and without cataract, other ocular comorbidities, or previous ocular surgery. The study follow‐up periods were three months (Khalifa 2011; Ozulken 2021) and six months (Barišić 2008; Barišić 2010). No study reported outcomes at 12 months or longer or provided information about economic evaluations. Each of the included studies compared a different pair of surgical interventions. Only three studies contributed useful outcome data (Barišić 2008; Barišić 2010; Ozulken 2021). The main results and judgments regarding the certainty of evidence are summarized in Table ; Table ; and Table . Two studies compared diffractive bifocal intraocular lens (IOL) implantation after refractive lens exchange (RLE) with another intervention. Barišić 2008 selected the implantation of refractive bifocal IOL after RLE as the comparator, while Barišić 2010 chose laser‐assisted in situ keratomileusis (LASIK) monovision as the comparator. Participants randomized to diffractive bifocal IOL showed no evidence of a difference in spectacle independence for near vision or participant satisfaction rate when compared either with refractive bifocal IOL implantation or with LASIK monovision. Regarding spectacle independence for intermediate vision, the diffractive bifocal IOL group showed no difference compared with the refractive bifocal IOL group; however, when compared with LASIK monovision, the intraocular surgery group showed slightly less spectacle independence for intermediate vision. Ocular adverse events (AEs) were slightly less frequent in the diffractive bifocal IOL group than in the refractive bifocal IOL group. The LASIK monovision group experienced fewer AEs than the diffractive bifocal IOL group. No data on bilateral contrast sensitivity (CS) or change in quality of life (QoL) was reported from these two RCTs. Ozulken 2021 compared diffractive trifocal IOL versus extended depth of focus (EDOF) IOL after RLE. The publication of study findings was the only one that stated that there was no financial conflict of interest or external funding, and it was the only one that reported a QoL outcome. The very small differences between the two interventions regarding improvement in QoL scores and binocular uncorrected distance visual acuity after three months were too small to be interpreted as clinically meaningful. In addition, we assessed the evidence as very low and low certainty, respectively. No data regarding spectacle independence for near or intermediate distances, participant satisfaction, CS, or ocular AE were available for comparison of the two surgical interventions. Khalifa 2011 reported data that suggested that uncorrected near vision in the modified wavefront‐guide (WG) LASIK arm was better than after the conventional technique at three months; however, data, as reported, could not be analyzed quantitatively. In addition, no evidence of a difference in uncorrected distance vision or change in CS was reported. No data for spectacle independence, QoL, participant satisfaction, or ocular AE were provided for this comparison of two LASIK procedures. Limitations of the evidence included in the review With an aging population, the field of presbyopia research continues to evolve rapidly. However, contrary to what we expected, we identified a paucity of evidence relating to the comparative effectiveness and safety of surgical interventions for presbyopia focusing on phakic patients without cataracts or in pseudophakic patients with monofocal IOLs. The included trials varied in methodologic quality; sample sizes were small, and follow‐up of participants for outcomes was short, no longer than six months. Most of the evidence was of low or very low certainty. Only one study reported outcome data for all critical outcomes specified for our review, and only two trials reported ocular AEs or intervention‐related AEs, respectively. Additionally, none of the included studies provided information regarding the economic aspects of the different surgical options. Of the four studies identified and included, each evaluated a different pair of comparisons; only three reported data for the outcomes we had targeted. No summary meta‐analysis could be conducted. Therefore, the available evidence was insufficient to address the review objectives and limited our ability to draw conclusions. Study characteristics The four included studies were single‐center RCTs conducted in Croatia, Egypt, and Turkey. Most (3/4, 75%) were published almost 15 years ago, and only one in 2021. The specific IOLs evaluated in Barišić 2008 and Barišić 2010 are no longer commercially available. None of the trials reported the review outcomes at 12 months. Reporting of trial methods was often insufficient. The relatively short follow‐up, with only three or six months of available data, did not allow for the analysis of potential long‐term events that may impact on the effectiveness and safety of the different surgical options. For instance, additional regression may occur, particularly after hyperopic LASIK, leading to decreased visual acuity and an increased rate of enhancements at later follow‐up visits [ 79 ]. Some visual disturbances related to the laser ablation profile may improve over time. Even though full correction can be achieved with LASIK monovision – which may be challenging in cases of anisometropia – presbyopia will continue progressing with age, requiring further optical correction for optimal near vision [ 25 ]. On the other hand, neuroadaptation to multifocal IOLs typically occurs within six to 12 months; however, some patients may fail to adapt and require surgical management later on [ 80 ]. Retinal detachment is among the serious adverse events after RLE, particularly in patients with axial lengths greater than 23 mm, with an increased risk that persists for several years [ 81 ]. Additionally, posterior capsule opacification occurs in about 50% of patients in the five years postoperatively, which can further impact visual outcomes [ 82 ]. Participant characteristics The included studies likely enrolled different participant populations in the three countries, although they did not provide specific data about ancestry or ethnicity. Additionally, while all studies enrolled participants with a diagnosis of presbyopia, none reported a clear description of the diagnostic criteria used or a method of assessment of severity. As a progressive condition that gradually increases in severity with age, different grades of presbyopia severity are expected in populations at different ages. The mean ages of the participants ranged from 46 to 58 years, with the youngest participants being those reported in Khalifa 2011 and the oldest in Ozulken 2021. Most studies reported no important differences in age and gender between each pair of interventions. However, in the study reported by Barišić 2010, participants treated with LASIK monovision were younger than those allocated to RLE with diffractive bifocal IOL implantation. Young (mild) presbyopes typically retain their intermediate vision for several years, but older (advanced) ones likely do not [ 3 ]; therefore, age is a critical factor to consider when assessing the results, particularly regarding intermediate distances. On the other hand, all enrolled participants had presbyopia and no other comorbidities such as cataracts, glaucoma, diabetes mellitus, age‐related macular degeneration, or myopic retinopathy. To date, no RCT has been identified that compares the effectiveness and safety of surgical interventions for presbyopia in people with pseudophakic presbyopia (whose lens has been removed and replaced by a monofocal IOL) or those with previous corneal refractive surgery. Thus, the benefits and potential risks of surgical interventions for these populations are unknown. Interventions and comparisons We identified one study per comparison pair. Outcome data could not be combined in a meta‐analysis because the intervention pair differed in each trial and follow‐up periods varied. Two studies compared two intraocular surgeries. Barišić 2008 compared the implantation of diffractive bifocal IOL with refractive bifocal IOL at six months, while Ozulken 2021 compared diffractive trifocal IOL with EDOF IOL at three months. Two studies considered corneal refractive surgery; Barišić 2010 compared intraocular surgery with corneal refractive surgery at six months, while Khalifa 2011 compared modified with conventional corneal refractive surgery at three months. Therefore, it is currently unknown whether the different interventions may yield different benefits or harms, although the available evidence considered in this review is consistent with little or no superiority regarding the benefit or harm of any of the surgical interventions for presbyopia. Certainty of the evidence The certainty of the evidence was mainly low to very low across the outcomes evaluated in this review. We downgraded all the outcomes for risk of bias arising from an inadequate description of the randomization process in each trial. Investigators from none of the four studies reported how the random sequence was generated or the method of concealing treatment allocation before assignment. We also downgraded the certainty of evidence for most outcomes for risk of bias arising from their measurement, particularly for subjective outcomes in the setting of an unmasked trial. On the other hand, we assessed all the outcomes across all the studies to be at low risk of bias for deviations from the intended interventions and missing outcome data because all the randomized participants were included in the analyses, and all the outcome data were available from each study for all the outcomes they had measured. We rated three of the four studies to be at low risk of bias for selective outcome reporting. We judged Ozulken 2021 to be at high risk of bias for change in quality of life because there was no publicly available protocol, and the study did not follow the conventional scoring method to calculate scores. Financial support as a potential source of bias could not be adequately assessed in all studies as only one provided pertinent information (Ozulken 2021). Limitations of the review processes We followed standard methodological procedures for systematic reviews of interventions. The review protocol was prospectively registered [ 51 ], and all the outcome measures of interest were specified in advance. A comprehensive literature search of multiple electronic databases, trials registers, and other resources was performed by a specialist; we were able to capture one ongoing study ( NCT04617080 ) and three completed studies that await classification (Belmont 2007; Bohorquez 2008; NCT04156737 ) for this review. Publication of findings from those studies may provide more robust estimates of absolute and relative effects. Moreover, in order to reduce potential bias during selection, data extraction, and risk of bias assessment of the studies, two review authors independently completed all the steps in the review process, and resolved any discrepancies between them by discussion or with the involvement of a third review author. Although we contacted investigators to seek unpublished data regarding methods or outcomes, we failed to obtain additional data beyond those provided in the published reports. Due to an insufficient number of eligible studies, we could not conduct any quantitative synthesis or evaluate potential publication bias through the construction of funnel plots. Agreements and disagreements with other studies or reviews This systematic review is the first to evaluate evidence provided by RCTs related to the comparative effectiveness and safety of surgical interventions for presbyopia, which is caused by a reduction in the lens’ ability to change its shape when focusing at near and intermediate distances. Most of the available evidence is centered on patients whose lenses have already lost transparency (i.e. those in whom cataract has developed), which leads to a gradual loss of the quality and quantity of distance and near vision. In a patient with cataracts, for whom conservative measures are not enough, the surgical removal of the cloudy lens material followed by the implantation of a synthetic IOL (i.e. cataract surgery) is the only available option proven to be effective and safe for visual rehabilitation in affected individuals [ 83 ]. According to the optical design of the IOL used in cataract surgery, it is possible to improve not only distance vision but also near vision; this type of IOL has been called 'presbyopia‐correcting IOL' [ 44 ]. This clinical scenario has been extensively addressed in four previous Cochrane reviews [ 45 , 46 , 47 , 48 ]. Moreover, recommendations on using presbyopia‐correcting IOLs have been published [ 84 ]. Recently, a functional classification of IOLs has been proposed [ 85 ]. This classification was based on defocus curves, recognized as a complementary tool for assessing visual performance and guiding clinical decisions among different types of IOLs [ 86 ]. Presbyopia is a condition that requires progressively increasing the optical power of reading glasses or contact lenses (known as 'near addition') as a person ages, even though the lens remains clear. A cataract is considered a more advanced stage of aging than presbyopia [ 87 ]; therefore, results from previous systematic reviews on people with cataracts cannot be directly extrapolated to phakic patients with presbyopia but without cataracts. On the other hand, in people with presbyopia, different surgical options, such as corneal‐based procedures or scleral approaches, have been reported [ 22 , 32 ]. Two systematic reviews that assessed the clinical outcomes of LASIK for presbyopia have been published [ 23 , 88 ]. They reported satisfactory efficacy, predictability, and stability of near vision with decreased vision at far distances; however, they involved only non‐randomized controlled trials and non‐comparative studies. Although we found no evidence suggesting that one surgical approach is superior to another, participants enrolled in each treatment group showed reasonable rates of spectacle independence and a low incidence of visual disturbances. This was in agreement with several single‐arm studies. For instance, studies on bilateral bifocal IOL implantation after RLE, including refractive [ 89 ], diffractive [ 90 , 91 , 92 ], and refractive‐diffractive IOLs [ 93 ], claimed satisfactory clinical results in presbyopic individuals. Similar findings were reported in non‐comparative studies on bilateral trifocal IOL implantation after RLE [ 94 , 95 , 96 , 97 , 98 ]. Moreover, it was reported that binocular near visual acuity (VA) was better for participants who underwent bilateral surgery than unilateral surgery [ 99 ]. Unlike Ozulken 2021, a non‐interventional comparative study found better near VA in participants who underwent trifocal IOL implantation than those scheduled for EDOF IOL implantation [ 100 ]. On the other hand, one study compared EDOF IOL implantation after RLE and LASIK monovision [ 101 ]. In this retrospective study, Schallhorn and colleagues found that participants with presbyopia and hyperopia (sphere between +0.25 and +3.00 D) who underwent RLE achieved better binocular uncorrected distance VA [ 101 ]. In contrast, those with moderate to high myopia (i.e. sphere of ‐3.25 D or less) scheduled for LASIK monovision had better binocular near VA. Additionally, participants with moderate to high myopia who underwent LASIK monovision reported higher satisfaction rates, while all myopic individuals in the RLE group experienced more visual disturbances than those in the LASIK monovision group. The economic impact of vision correction for presbyopia extends beyond individual patient costs to broader societal expenses, which are disproportionately higher in low‐income countries. Costs and clinical effectiveness vary significantly across studies [ 102 ]. In the USA, over‐the‐counter near‐vision spectacles cost about USD 20 per pair, while multifocal or ‘progressive’ spectacles range from USD 70 to USD 500 annually, depending on additional features. Contact lenses cost approximately USD 600 per year for monofocal and USD 900 for multifocal options. LASIK for monovision correction ranges from USD 2500 to USD 3500 per eye, with the eventual need for spectacle correction for near vision once again as the patient ages and, ultimately, cataract surgery [ 103 ]. The cost of IOL implantation varies widely depending on the type of IOL selected. A recent survey among delegates of the European Society of Cataract and Refractive Surgeons identified 'cost to the patient' as the most significant barrier to the broader adoption of presbyopia‐correcting IOLs [ 104 ]. Economic analyses comparing multifocal and monofocal IOLs indicate that multifocal IOLs provide superior cost‐effectiveness for those who are seeking spectacle independence and are willing to pay at their own cost [ 105 , 106 , 107 , 108 , 109 ]. Among different bilateral IOL implantation strategies, the trifocal approach has been identified as the most effective but also the most expensive, while the refractive bifocal strategy was the most cost‐effective, offering relatively low costs. The EDOF approach outperformed the diffractive bifocal strategy but remained slightly less effective than the refractive bifocal option; however, its relatively high cost limited its overall cost‐effectiveness. Monovision was the least expensive but also the least cost‐effective option [ 110 ]. Since these studies focus on cataract patients, their findings cannot be directly extrapolated to younger presbyopic individuals without cataracts, who have higher visual demands and are at greater risk of dissatisfaction and visual disturbances from multifocal IOLs after RLE surgery [ 103 ]. Moreover, depending on their country's healthcare system, RLE patients typically incur higher costs than cataract patients [ 111 ]. Likewise, comparisons of corneal‐based procedures suggest that laser cornea refractive surgery is cost‐effective for refractive correction [ 112 , 113 , 114 ]. However, no economic evaluation has been performed on presbyopic patients. Therefore, this apparent shortage of relevant economic evaluations suggests a lack of economic evidence comparing different surgical interventions for presbyopia in phakic patients without cataracts or pseudophakic patients with monofocal IOLs. Authors' conclusions Implications for practice According to the current, best‐available clinical evidence, there may be no evidence of a difference in the comparative effectiveness and safety of surgical interventions for presbyopia. The available data were limited to short‐term (three months) and mid‐term (six months) outcomes and are of low or very low certainty. There is little or no information assessing the quality of life, contrast sensitivity, or ocular adverse events; no study to date has evaluated economic aspects of surgical interventions for presbyopia. We found no information for people with pseudophakic presbyopia (those previously treated with a monofocal intraocular lens) or with a history of corneal refractive surgery. Caution is therefore advised when using current evidence to make clinical practice decisions due to the limitations of the evidence already described. Equity‐related implications for practice We did not assess health inequity. Implications for research Well‐planned, adequately powered, high‐quality randomized controlled trials of different surgical interventions to overcome the near and intermediate visual impairment of presbyopia should be designed to stratify participants by age, severity, ocular history, and type of presbyopia presentation, including pseudophakic presbyopia. They should also enroll participants who have a history of corneal refractive surgery. Future studies should use validated tools to measure and score outcomes, particularly participant‐reported outcomes. Additionally, they should include defocus curves in assessing the visual performance of intraocular lenses. Completed trials should be reported following the recommended guidelines, such as CONSORT. The ongoing study ( NCT04617080 ), and those classified as awaiting classification (Belmont 2007; Bohorquez 2008; NCT04156737 ), should add more evidence when reported and be reassessed when supplementary information becomes available. This, along with the emergence of new technologies, may suggest that an update to this review may be appropriate in the near future. Equity‐related implications for research We did not assess health inequity. Supporting Information Supplementary materials are available with the online version of this article: 10.1002/14651858.CD015711. Supplementary materials are published alongside the article and contain additional data and information that support or enhance the article. Supplementary materials may not be subject to the same editorial scrutiny as the content of the article and Cochrane has not copyedited, typeset or proofread these materials. The material in these sections has been supplied by the author(s) for publication under a Licence for Publication and the author(s) are solely responsible for the material. Cochrane accordingly gives no representations or warranties of any kind in relation to, and accepts no liability for any reliance on or use of, such material. Supplementary material 1 Search strategies CD015711-SUP-01-searchStrategy.html (35.8KB, html) Supplementary material 2 Characteristics of included studies CD015711-SUP-02-characteristicsOfIncludedStudies.html (56.5KB, html) Supplementary material 3 Characteristics of excluded studies CD015711-SUP-03-characteristicsOfExcludedStudies.html (46.7KB, html) Supplementary material 4 Characteristics of studies awaiting classification CD015711-SUP-04-characteristicsOfAwaitingStudies.html (37.9KB, html) Supplementary material 5 Characteristics of ongoing studies CD015711-SUP-05-characteristicsOfOngoingStudies.html (31.5KB, html) Supplementary material 6 Risk of bias CD015711-SUP-06-riskOfBias2.html (55.2KB, html) Supplementary material 7 Analyses CD015711-SUP-07-analyses.html (178.5KB, html) Supplementary material 8 Data package CD015711-SUP-08-dataPackage.zip (38.7KB, zip) Supplementary material 9 Risk of bias of Khalifa 2011 reported outcomes CD015711-SUP-09-other.html (36.2KB, html) New Additional information Acknowledgements Acknowledgments from the authors We thank Lori Rosman, Information Specialist for Cochrane Eyes and Vision (CEV), who created and executed the electronic search strategies, and Barbara Hawkins, Pre‐Sign‐off Editor for CEV (Johns Hopkins University). We would also like to thank Sumayya Ahmad, Icahn School of Medicine of Mount Sinai (clinical/content review); Laura K Green, Sinai Hospital of Baltimore (clinical/content review); Yuan Chi, Cochrane Campbell Global Ageing Partnership (search review) for their comments on the review protocol. Editorial and peer‐reviewer contributions Cochrane Eyes and Vision (CEV) supported the authors in the development of this review. The following people conducted the editorial process for this article. Sign‐off Editors (final editorial decision): Tianjing Li (University of Colorado Anschutz Medical Campus) Managing Editor (selected peer reviewers, provided editorial guidance to authors, edited the article): Anupa Shah, Central Editorial Service Editorial Assistant (conducted editorial policy checks, collated peer‐reviewer comments and supported editorial team): Jacob Hester, Central Editorial Service Copy Editor (copy editing and production): Andrea Takeda, Cochrane Central Production Service. Peer‐reviewers (provided comments and recommended an editorial decision): Sumayya Ahmad, Icahn School of Medicine of Mount Sinai (clinical/content review); Dr Denny Mathew John, Assistant Professor, Department of Community Medicine, Saveetha Medical College and Hospital Chennai, India (consumer review); Nuala Livingstone, Cochrane Evidence Production and Methods Directorate (methods review); Jo Platt, Central Editorial Information Specialist (search review); Carlos Rocha‐de‐Lossada 1‐Qvision, Vithas Almeria, Department of Ophthalmology 2‐Vithas Malaga, Department of Ophthalmology 3‐Regional University Hospital of Malaga, Department of Ophthalmology 4‐University of Seville (clinical/content review). Contributions of authors Screening search results: RAV, MJMZ, TWY, EHQ, EDG, CLM. Data extraction: RAV, MJMZ. Risk of bias assessment: RAV, MJMZ. Data verification: TWY. Data interpretation: RAV, MJMZ, TWY. Writing of the manuscript: RAV, MJMZ, TWY. Final approval of the manuscript: RAV, MJMZ, TWY, EHQ, EDG, CLM. Declarations of interest RAV: none known. TWY: reports a grant UG1 EY020522 from the National Eye Institute, National Institutes of Health, USA; payment to institution; Cochrane methodologist but was not involved in the editorial process for this review. EHQ: has received honoraria for speaking at educational events organized by Allergan and sitting on an advisory board organized by Twenty Twenty therapeutics LLC, Thea Laboratories, Centro de Investigacion Sophia, and Allergan; and has received grant support from Alcon, Inc. EDG: none known. CLM: none known. MJMZ: none known. Sources of support Internal sources None, Other No internal source of support External sources Public Health Agency, UK The HSC Research and Development (R&D) Division of the Public Health Agency funds the Cochrane Eyes and Vision editorial base at Queen's University Belfast up to 31 st March 2023. Queen's University Belfast, UK Gianni Virgili, Co‐ordinating Editor for Cochrane Eyes and Vision’s work, is funded by the Centre for Public Health, Queen’s University of Belfast, Northern Ireland up to 31 st March 2023. National Eye Institute, National Institutes of Health, USA Cochrane Eyes and Vision US Project, supported by grant UG1EY020522 (PI: Tianjing Li, MD, MHS, PhD). Registration and protocol Protocol (2023) doi.org/10.1002/14651858.CD015711 [ 51 ]. Data, code and other materials As part of the published Cochrane review, the following are made available for download for users of the Cochrane Library: full search strategies for each database ( Supplementary material 1 ); full citations of each unique report for all studies included ( Supplementary material 2 ), ongoing ( Supplementary material 5 ) or awaiting classification ( Supplementary material 4 ), or excluded at the full‐text screen ( Supplementary material 3 ); study data, including study information, study arms, and study results ( Supplementary material 8 ); consensus risk of bias assessments ( Supplementary material 6 ; Supplementary material 9 ); and analysis data, including overall estimates and settings, subgroup estimates, and individual data rows ( Supplementary material 7 ). Appropriate permissions have been obtained for such use. Analyses and data management were conducted within Cochrane’s authoring tool, RevMan, using the inbuilt computation methods. 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Supplementary Materials Supplementary material 1 Search strategies CD015711-SUP-01-searchStrategy.html (35.8KB, html) Supplementary material 2 Characteristics of included studies CD015711-SUP-02-characteristicsOfIncludedStudies.html (56.5KB, html) Supplementary material 3 Characteristics of excluded studies CD015711-SUP-03-characteristicsOfExcludedStudies.html (46.7KB, html) Supplementary material 4 Characteristics of studies awaiting classification CD015711-SUP-04-characteristicsOfAwaitingStudies.html (37.9KB, html) Supplementary material 5 Characteristics of ongoing studies CD015711-SUP-05-characteristicsOfOngoingStudies.html (31.5KB, html) Supplementary material 6 Risk of bias CD015711-SUP-06-riskOfBias2.html (55.2KB, html) Supplementary material 7 Analyses CD015711-SUP-07-analyses.html (178.5KB, html) Supplementary material 8 Data package CD015711-SUP-08-dataPackage.zip (38.7KB, zip) Supplementary material 9 Risk of bias of Khalifa 2011 reported outcomes CD015711-SUP-09-other.html (36.2KB, html) Data Availability Statement As part of the published Cochrane review, the following are made available for download for users of the Cochrane Library: full search strategies for each database ( Supplementary material 1 ); full citations of each unique report for all studies included ( Supplementary material 2 ), ongoing ( Supplementary material 5 ) or awaiting classification ( Supplementary material 4 ), or excluded at the full‐text screen ( Supplementary material 3 ); study data, including study information, study arms, and study results ( Supplementary material 8 ); consensus risk of bias assessments ( Supplementary material 6 ; Supplementary material 9 ); and analysis data, including overall estimates and settings, subgroup estimates, and individual data rows ( Supplementary material 7 ). Appropriate permissions have been obtained for such use. Analyses and data management were conducted within Cochrane’s authoring tool, RevMan, using the inbuilt computation methods. Template data extraction forms from Covidence are available from the authors on reasonable request. 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