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Clinical Trial Summary

The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation. The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision? Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following: - consent to participate in the study - allow researchers to access their personal medical records - undergo a series of tests to assess the position of their IOLs and quality of vision Researchers will compare the patients' preoperative and postoperative test results to determine whether an association exists between IOL movement and patient quality of vision.


Clinical Trial Description

This is a non-interventional, single center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are reached. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05827133
Study type Observational
Source East Coast Institute for Research
Contact Rebecca Goldfaden, PharmD
Phone (904) 854-1354
Email rg@eastcoastresearch.net
Status Recruiting
Phase
Start date July 10, 2023
Completion date April 30, 2024

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