Clincosm LogoSign in Get a demo

Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery

Sponsor
Ilasis Laser (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05141370
Collaborator
(none)
78
Enrollment
1
Location
1
Arm
6.9
Anticipated Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: cataract surgery with CATSYS
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery
Actual Study Start Date :
Feb 3, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Continuity of the capsulorhexis (success / failure) [During surgery]

    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.

Secondary Outcome Measures

  1. Adverse device effects [3 to 5 days after surgery]

    Collection of adverse device effects by the investigator on the retina, on the cornea, on the posterior capsula and other adverse device events

  2. Adverse events [3 to 5 days post-surgery;]

    Collection by the investigator of other adverse events

  3. Ocular adverse events [30 ± 10 days post-surgery.]

    Collection by the investigator of ocular adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Opthalmologique Sourdille Atlantique Saint-Herblain France 44800

Sponsors and Collaborators

  • Ilasis Laser

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ilasis Laser
ClinicalTrials.gov Identifier:
NCT05141370
Other Study ID Numbers:
  • 2021-A02331-40
First Posted:
Dec 2, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Mar 29, 2022