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

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

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: cataract surgery with 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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DELOISON Florent; Phone Number: +33 601 911 003; Email: florent.deloison@ilasis.com

Study Locations

• France
  • Saint-Herblain, France, 44800
    • Institut Opthalmologique Sourdille Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hand-held femtosecond laser; Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS.	Device: cataract surgery with CATSYS; patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuity of the capsulorhexis (success / failure)	Success achieved if: the anterior capsule is completely cut (rhexis is free floating or easy to remove); AND there are no peripheric tears that can generate the rupture of the capsule at the end of rhexis removal.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse device effects	Collection of adverse device effects by the investigator on the retina, on the cornea, on the posterior capsula and other adverse device events	3 to 5 days after surgery
Adverse events	Collection by the investigator of other adverse events	3 to 5 days post-surgery;
Ocular adverse events	Collection by the investigator of ocular adverse events	30 ± 10 days post-surgery.

Collaborators and Investigators

• Sponsor: Ilasis Laser

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2021-A02331-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No