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Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

Cataract Surgery Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05141370
Study type Interventional
Source Ilasis Laser
Contact
Status Completed
Phase N/A
Start date February 3, 2022
Completion date April 3, 2023
View Details
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