RecruitingNCT07362043

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

Sponsor

Helix Surgical

Enrollment

446 participants

Start Date

Jan 28, 2026

Study Type

OBSERVATIONAL

Conditions

Cataract Surgery

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria15

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 interfere with stabilization of the device on the limbus: pterygium, limbal tumor, filter bubble, etc.
Patients under guardianship, trusteeship or deprived of liberty;
Patients unable to give their non-opposition for data collection for psychiatric, cognitive or linguistic reasons.