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RECRUITING
NCT07362043

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

Sponsor: Helix Surgical

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

446

Start Date

2026-01-28

Completion Date

2028-03

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DEVICE

Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy (CE-marked device used as intended)

Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy

Locations (1)

Santé Atlantique

Saint-Herblain, France