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

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.

NCT Number	NCT07362043
Lead Sponsor	Helix Surgical Collaborators: Santé Atlantique - Saint-Herblain - France
Conditions	Cataract Surgery
Enrollment	446 participants
Start Date	2026-01-28
Primary Completion	2028-01 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-01-30