NCT05141370

Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Ilasis Laser · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.

Detailed description

Interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. The "first-in-man" character of this investigation relies on the ergonomics of CATSYS (handpiece), and not on the laser technique, which is similar to other FLACS. The purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining CE-mark for CATSYS.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
DEVICE	cataract surgery with CATSYS	patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS

Timeline

• Start date: 2022-02-03
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2021-12-02
• Last updated: 2023-10-02

Locations

1 site across 1 country: France