Hand-held femtosecond laser for anterior capsulotomy during cataract surgery

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

This project will test whether using a hand-held femtosecond laser (Rx) for anterior capsulotomy in adults having cataract surgery results in a capsular rupture rate below 2%.

Quick facts

• Study type: Observational
• Enrollment: 446 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Helix Surgical (Industry-sponsored)
• Locations: 1 site (Saint-Herblain)
• Trial ID: NCT07362043 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional, post‑market clinical follow‑up performed at a single center to supplement pre‑market data on a CE‑marked hand‑held femtosecond laser used for anterior capsulotomy. The design is single‑arm and sequential: medical records of patients treated as part of routine care will be followed for 30 ± 15 days and interim analyses will be performed after prespecified sequences. The analysis combines 78 pre‑market patients with up to 368 additional participants (maximum total 446) to test whether the rupture rate remains below pre-specified limits with stopping rules for success or failure. The device is used as intended during standard phacoemulsification with lens implantation and outcomes focus on capsular rupture rates.

Who should consider this trial

Good fit: Adults over 18 with cataract scheduled for phacoemulsification under local anesthesia who meet anatomical criteria (anterior chamber depth 1.8–4.2 mm), achieve adequate pupil dilation, and consent to routine data collection are ideal candidates.

Not a fit: Patients with contraindications such as prior Rx use in the first eye, ACD outside 1.8–4.2 mm, corneal disease preventing applanation or laser transmission, inadequate pupil dilation (<6.5 mm), significant ocular media opacities, or other surgical contraindications are unlikely to be eligible or benefit from inclusion.

Why it matters

Potential benefit: If successful, the data could confirm a low capsular rupture rate with this handheld laser and support safer, more predictable anterior capsulotomies and broader clinical confidence in the device.

How similar studies have performed: Other femtosecond laser platforms have demonstrated improved capsulotomy precision and acceptable complication rates in prior work, and a pre‑market investigation of this specific Rx device already included 78 patients.

Eligibility criteria

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.

Where this trial is running

Saint-Herblain

• Santé Atlantique — Saint-Herblain, France (Recruiting)

Conditions Cataract Surgery