Clinical trial NCT05141370: Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery
Official title: Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Lead sponsor: Ilasis Laser
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Continuity of the capsulorhexis (success / failure)
timeFrame: During surgery
Secondary outcomes:
measure: Adverse device effects
timeFrame: 3 to 5 days after surgery
measure: Adverse events
timeFrame: 3 to 5 days post-surgery;
measure: Ocular adverse events
timeFrame: 30 ± 10 days post-surgery.
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut Opthalmologique Sourdille Atlantique
Study officials:
References: