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Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
Sponsor: Helix Surgical
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
Conditions
Interventions
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