Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
Recruiting
Observational Study
Cataract Surgery
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 446 (estimated)
- Sponsor
- Helix Surgical · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patients (age \> 18 years);
* Diagnosed with cataract requiring surgery according to current guidelines;
* Eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia;
* Who confirmed their non-opposition to data collection…
Contacts
No contact information available.