Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Rate of capsule-ruptures due to Rx — During surgery
The investigator considers a rupture of the capsule will be Rx-related if: * There are peripheric tears that can generate the rupture of the capsule during or at the end of rhexis removal; * AND these tears generate the rupture of the capsule during surgery.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Santé Atlantique | Saint-Herblain | France |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07362043 on ClinicalTrials.gov ↗ ← All trials in France