Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Sur… (NCT07362043) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
France446 participantsStarted 2026-01-28
Plain-language summary
The goal of this observationnal study is to supplement the data collected in the pre-market study and confirm the rate of capsular ruptures due to Rx (reducing its related confidence interval).
During cataract surgery, an artificial lens is placed into the capsular bag. The main question this study aims to answer is :
Is Rx use associated with a rate of caspular ruptures lower than 2% ? Medical records of participants having cataract surgery with Rx laser as part of their regular medical care will be assessed in order to answer the study objective.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (age \> 18 years);
* 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 confirmed their non-opposition to data collection
Exclusion Criteria:
* Patient already operated with Rx for the first eye.
* Any contra-indication to cataract surgery;
* Patients with an ACD (Anterior Chamber Depth) less than 1.8mm and greater than 4.2mm;
* Corneal disease or pathology that prevents corneal applanation or that may interfere with or hinder laser beam transmission;
* Presence of blood or any other element that hinders the propagation of light between the epithelium and the anterior surface of the lens where the capsulotomy will be performed;
* Weak pupil dilation or severely off-center pupil that prevents the iris from retracting adequately to the periphery (dilations \< 6.5mm in diameter are excluded);
* Abnormal tilt of the lens (\> 7 degrees) ;
* Significant preoperative ocular hypotonia or hypertonia;
* Presence of an intra-corneal implant;
* Active or unstabilized ocular surface disease including abnormal corneas (e.g., epithelial dystrophies,recurrent ulcers, infectious foci, conjunctivitis, severe dry syndromes);
* History of lens disease or zonular instability;
* Any perforating incision of the eyeball that may result in leakage during corneal applanation;
* Presence of a limbal tumor obstacle that may i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.