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

Helix Surgical

Status: Enrolling

Conditions: Cataract Surgery

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07362043

CER-BDX 2025-157

Details and patient eligibility

About

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.

Full description

This study is a PMCF, sequential, non-interventional, prospective (follow-up: 30 ± 15 days), single-arm, single center, open trial.

Note: The design of this study is identical to the one of the Rx pre-market investigation (same design, same endpoints, same investigation site, same follow-up).

78 patients have been included in the pre-market investigation and will be used as part of dataset of the current PMCF study.

Sample size calculation (Wilson Method):

Considering the design of this study is identical to the one of the Rx pre-market investigation and that 78 patients have already been included in that pre-market clinical investigation (NCT05141370);

Assuming a rate of capsule-ruptures due to Rx < 2%;

And an upper limit ≤ 3.5%;

The maximum number of patients to be included will be 446 patients (considering 78 patients have already been included, 368 remain to be included), corresponding to 8 capsular ruptures and a rate of 1.79% with an interval of [0.91% ;3.5%].

The investigator proposes to conduct a sequential study in which the number of patients depends on a success criterion and a failure criterion as detailed below.

As the study is sequential, interim analyses at the end of each sequence are planned to examine whether the objective of an upper limit of rupture rate ≤3.5% (success) is achieved, or whether the rupture rate equals or exceeds 2% (failure).

The study stops as soon as a success or failure criterion is verified.

Sequence 1:

- 106 patients to reach:

• Success: 0 capsular rupture -> superior limit ≤ 3.5%
• Failure: ≥ 3 capsular ruptures -> a rupture rate ≥ 2%

If 1 ≤ number of capsular ruptures ≤2 the trial continues

Sequence 2:

- 158 patients to reach:

• Success: 1 capsular rupture -> superior limit ≤ 3.5%
• Failure: ≥ 4 capsular ruptures -> a rupture rate ≥ 2%

If 2 ≤ number of capsular ruptures ≤3 the trial continues

Sequence 3:

- 205 patients to reach:

• Success: 2 capsular ruptures -> superior limit ≤ 3.5%
• Failure: ≥ 5 capsular ruptures -> a rupture rate ≥ 2%

If 3 ≤ number of capsular ruptures ≤4 the trial continues

Sequence 4:

• 248 patients to reach:

  • Success: 3 capsular ruptures -> superior limit ≤ 3.5%
  • Failure: ≥ 5 capsular ruptures -> a rupture rate ≥ 2%

If 4 capsular ruptures the trial continues

Sequence 5:

- 290 patients to reach:

• Success: 4 capsular ruptures -> superior limit ≤ 3.5%
• Failure: ≥ 6 capsular ruptures -> a rupture rate ≥ 2%

If 5 capsular ruptures the trial continues

Sequence 6:

- 330 patients to reach:

• Success: 5 capsular ruptures -> superior limit ≤ 3.5%
• Failure: ≥ 7 capsular ruptures -> a rupture rate ≥ 2%

If 6 capsular ruptures the trial continues

Sequence 7:

- 370 patients to reach:

• Success: 6 capsular ruptures -> superior limit ≤ 3.5%
• Failure: ≥ 8 capsular ruptures -> a rupture rate ≥ 2%

If 7 capsular ruptures the trial continues

Sequence 8:

- 408 patients to reach:

• Success: 7 capsular ruptures -> superior limit ≤ 3.5%
• Failure: ≥ 9 capsular ruptures -> a rupture rate ≥ 2%

If 8 capsular ruptures the trial continues

Sequence 9:

• 446 patients to reach:

  • Success: 8 capsular ruptures -> superior limit ≤ 3.5%

  • Failure: ≥ 9 capsular ruptures -> a rupture rate ≥ 2%

    446 patients is the maximum number of patients to be included in the study, as no condition other than success or failure can be verified.

Enrollment: 446 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.