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Completed Observational

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

NCT07362043 · tracked via the Priya Life Science France tracker
Sponsor
Helix Surgical
Phase
Observational
Started
2026-01-28
Last updated
2026-10-29

Condition(s) studied

Cataract Surgery

Investigational drug(s) / intervention(s)

Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy (CE-marked device used as intended)

Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy (CE-marked device used as intended): Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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.

Primary outcome measure(s)

  • Rate of capsule-ruptures due to Rx — During surgery
    The investigator considers a rupture of the capsule will be Rx-related if: * There are peripheric tears that can generate the rupture of the capsule during or at the end of rhexis removal; * AND these tears generate the rupture of the capsule during surgery.

Trial sites (1)

FacilityCityRegionStatus
Santé Atlantique Saint-Herblain France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362043 on ClinicalTrials.gov ↗ ← All trials in France