RecruitingNCT07362043

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

Sponsor

Helix Surgical

Enrollment

446 participants

Start Date

Jan 28, 2026

Study Type

OBSERVATIONAL

Conditions

Cataract Surgery

Summary

The goal of this observationnal study is to supplement the data collected in the pre-market study and confirm the rate of capsular ruptures due to Rx (reducing its related confidence interval). During cataract surgery, an artificial lens is placed into the capsular bag. The main question this study aims to answer is : Is Rx use associated with a rate of caspular ruptures lower than 2% ? Medical records of participants having cataract surgery with Rx laser as part of their regular medical care will be assessed in order to answer the study objective.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy (CE-marked device used as intended) for people with cataract surgery. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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