Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

NCT ID: NCT05141370

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2023-04-03

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

hand-held femtosecond laser

Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS.

Group Type: EXPERIMENTAL

cataract surgery with CATSYS

Intervention Type: DEVICE

patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS

Interventions

cataract surgery with CATSYS

patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 have been informed and gave informed consent to participate in the study.

Exclusion Criteria

• Eye with an anterior chamber depth < 2.5 mm or > 3.8 mm;
• Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light;
• Eye with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally;
• Patient with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye;
• History of steroid-responsive rise in IOP, glaucoma, or preoperative IOP>21 mm Hg in either eye;
• Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, pseudoexfoliation syndrome, etc;
• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye;
• Any recent penetrating incision of the eyeball;
• Tilt of lens > 7;
• Presence of any obstacle that may interfere with the stabilization of the device on the limbus: pterygium, limbic tumor, etc;
• Pregnant or lactating woman;
• Patient with any contra-indication to neosynephrine, tropicamide and oxybuprocaïne;
• Patient presenting any contraindications to cataract surgery under local anesthesia (ex: allergy to anesthetic drops; neurodegenerative disease; schizophrenia; severe anxiety; etc.);
• Patient who participates to another clinical trial (except observational studies), or in the exclusion period of another clinical trial;
• Patient under guardianship, trusteeship or deprived of liberty;
• Patient not affiliated to the French social security system;
• Patient unable to participate in the study for psychiatric, cognitive or linguistic reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilasis Laser

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Opthalmologique Sourdille Atlantique

Saint-Herblain, , France

Countries

France

Other Identifiers

2021-A02331-40

Identifier Type: -

Identifier Source: org_study_id