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Virtual Eye Model System for Personalised Refractive Surgery Treatment

Vissum, Instituto Oftalmológico de Alicante · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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Justification: Although great strides have been made in the past to develop VEMoS software, it has not yet been validated with actual clinical data from patients who have undergone cataract or refractive surgery. There are some fundamental questions that must be addressed to validate and update the software, such as the objective visual quality metrics that best predict the patient's post-surgical subjective vision from the predictions of the optical properties of the eye. The VEMoS software must be adjusted for different types of inputs and eye parameters: Corneal tomography of MS39-AXL MS39-AXL corneal tomography + biometric data from the IOL Master MS39-AXL corneal tomography + IOL Master biometric data + total aberrometry Combinations of any of the above with the optical properties of a specific IOL, etc. Objective The main objective is to standardize the selection of parameters to personalize refractive surgery, based on the biometric data of each patient. The objectives necessary to achieve such an ambitious goal are: 1. Redesign VEMoS software 2. Determine which biometric data, diagnostic tools, and objective and subjective metrics of visual quality are best for the selection of optimal refractive parameters for surgery 3. Optimize the combined use of biometric data, VEMoS software, and visual quality metrics Study design The proposed multicenter clinical trial is observational and prospective. There will be three arms within the clinical trial, a no-treatment arm, a refractive surgery arm, and a cataract surgery arm. Participants in the untreated arm will undergo an ophthalmic exam only once. Participants in the other two arms will undergo two ophthalmic exams, one before and one after surgery. For all participants, cataract or refractive surgery will be performed as part of routine clinical practice. Other additional tests performed are all non-invasive. Study population Untreated eye arm patients 18 to 40 years of age. Refractive surgery arm patient
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