Back to resultsAssessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cataract surgery with CATSYS
Sponsored by
About this trial
This is an interventional other trial for Cataract Surgery
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.
Sites / Locations
- Institut Opthalmologique Sourdille Atlantique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hand-held femtosecond laser
Arm Description
Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Adverse events
Collection by the investigator of other adverse events
Ocular adverse events
Collection by the investigator of ocular adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141370
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ilasis Laser
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hand-held femtosecond laser
Arm Type
Experimental
Arm Description
Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS.
Intervention Type
Device
Intervention Name(s)
cataract surgery with CATSYS
Intervention Description
patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS
Primary Outcome Measure Information:
Title
Continuity of the capsulorhexis (success / failure)
Description
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.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Adverse device effects
Description
Collection of adverse device effects by the investigator on the retina, on the cornea, on the posterior capsula and other adverse device events
Time Frame
3 to 5 days after surgery
Title
Adverse events
Description
Collection by the investigator of other adverse events
Time Frame
3 to 5 days post-surgery;
Title
Ocular adverse events
Description
Collection by the investigator of ocular adverse events
Time Frame
30 ± 10 days post-surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institut Opthalmologique Sourdille Atlantique
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery
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