Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

NCT05141370 | Completed DMC

• 1 other identifier: 2021-A02331-40
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse device effects

  3 to 5 days after surgery

• Adverse events

  3 to 5 days post-surgery;

• Ocular adverse events

  30 ± 10 days post-surgery.

Study Arms (1)

hand-held femtosecond laser

EXPERIMENTAL

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

Device: cataract surgery with CATSYS

Interventions

cataract surgery with CATSYS DEVICE

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

hand-held femtosecond laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship, trusteeship or deprived of liberty;
• Patient not affiliated to the French social security system;

Sponsors & Collaborators

• Ilasis Laser: lead

Study Sites (1)

Institut Opthalmologique Sourdille Atlantique

Saint-Herblain, 44800, France

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: February 3, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)