Study to Confirm Safety of a Handheld Femtosecond Laser for Cataract Surgery Using the Rx Device

What this Trial Is About

Researchers are evaluating the rate of capsular ruptures during cataract surgery using a handheld femtosecond laser called Rx. This observational study aims to confirm if the rupture rate with Rx use is lower than 2%, supplementing data collected in a previous pre-market investigation. The study is conducted at a single center and follows patients prospectively for about 30 days after surgery. The study includes one group of patients undergoing cataract surgery with the Rx laser used as intended. The device is designed to assist in performing the anterior capsulotomy during surgery. The study uses a sequential design with up to 446 patients to monitor the rate of capsule ruptures. Interim analyses determine if the rupture rate meets success or failure criteria, potentially stopping the study early if clear results are found. Participants will have their medical records reviewed and will be followed for approximately 30 days after surgery to assess outcomes. Researchers will monitor the rate of capsule ruptures during surgery, the continuity of the capsulorhexis, and any adverse device effects immediately during surgery and at about 4 days and 30 days post-surgery. This study helps evaluate the safety of using the Rx laser in routine cataract surgery.

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