Cataract SurgeryNCT05141370
Assessment of a Femtosecond Laser to Perform Capsulorhexis During Cataract Surgery
A study testing cataract surgery with CATSYS in people with Cataract Surgery, run by Ilasis Laser at 1 site in France.
Trial summary
This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- cataract surgery with CATSYS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Opthalmologique Sourdille Atlantique
Saint-Herblain, 44800
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract Surgery
- Being tested
- cataract surgery with CATSYS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgery with CATSYSDevice
patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS
| Study group | Role | What they receive |
|---|---|---|
| hand-held femtosecond laser | Experimental | Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS. Receives: Device: cataract surgery with CATSYS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (3)
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
Measured: 3 to 5 days after surgery
Adverse events
Collection by the investigator of other adverse events
Measured: 3 to 5 days post-surgery;
Ocular adverse events
Collection by the investigator of ocular adverse events
Measured: 30 ± 10 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start3 Feb 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilasis Laser
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141370
- Sponsor's protocol ID
- 2021-A02331-40
- Status last verified
- Sep 2023
- First submitted
- 19 Nov 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery
- ClinicalTrials.gov ID
- NCT05141370
- Acronym / sponsor ID
- 2021-A02331-40
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ilasis LaserIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hand-held femtosecond laser | Experimental | Device: cataract surgery with CATSYSAnterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgery with CATSYSpatient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS | Device | hand-held femtosecond laser |
Primary outcome
Continuity of the capsulorhexis (success / failure)
Time frame: 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.
3 secondary outcomes
Adverse device effects
Time frame: 3 to 5 days after surgery
Adverse events
Time frame: 3 to 5 days post-surgery;
Ocular adverse events
Time frame: 30 ± 10 days post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Cataract Surgery
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Aphakia, Postcataract
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Effects of Oxygen Cage Support During Cataract Surgery
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Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery with CATSYS in people with Cataract Surgery, run by Ilasis Laser at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuity of the capsulorhexis (success / failure) (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.