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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelix Surgical

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Sponsors and collaborators

Helix Surgical

Lead sponsor

Santé Atlantique - Saint-Herblain - France

Collaborator