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ID06625749

Early Study of the AccuraSee17 Lens for Improving Near and Intermediate Vision After Cataract Surgery

Led by OnPoint Vision Inc · Updated on 2024-10-03

10

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the AccuraSee2 intraocular pseudophakic capsular lens IOPCL for improving near andor intermediate vision in people who have previously undergone cataract surgery. This study focuses on individuals who have had specific types of monofocal intraocular lenses implanted and are seeking better near vision through a myopic shift in the eye treated. The study is sponsored by OnPoint Vision Inc and aims to provide preliminary evidence regarding the devices performance. Participants will receive the AccuraSee2 IOPCL as a secondary implantation in the capsular bag. Eligible subjects must have had cataract surgery with certain monofocal lenses and meet specific vision requirements. The study includes a treatment period with the IOPCL implanted in the study eye. The primary measure of effectiveness is the improvement in uncorrected near visual acuity at 40 cm 16 inches evaluated 12 months after implantation. During the study, participants will attend postoperative visits for evaluations and monitoring. Researchers will assess visual acuity changes, particularly near vision, along with safety parameters related to the lens implantation. Participants must be able to complete all required visits and agree to avoid other refractive surgeries during the trial. The total participation duration extends through at least 12 months post-implantation to observe outcomes and monitor safety.

CONDITIONS

Brief Title

Evaluate the Safety and Effectiveness of the AccuraSee™ IOPCL for Secondary Implantation in the Capsular Bag to Improve Near and/or Intermediate Vision Following Previous Cataract Surgery

Research Team

L

Lynne Archer

T

Tonya Porter

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