NCT07362043

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

January 5, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 5, 2026

Last Update Submit

January 28, 2026

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of capsule-ruptures due to Rx

    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.

    During surgery

Secondary Outcomes (2)

  • Continuity of the capsulorhexis (success / failure)

    During surgery

  • Adverse device effects

    During surgery, 4 days after surgery (4 ± 2 days), 30 days after surgery (30 ± 15 days)

Other Outcomes (9)

  • Patient's perception about Rx use (exploratory endpoint)

    During surgery

  • Rx usability (exploratory endpoint)

    During surgery

  • Circularity of the capsulorhexis (exploratory endpoint)

    During surgery

  • +6 more other outcomes

Interventions

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

Cataract surgery with Rx, a handheld femtosecond laser for anterior capsulotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients eligible for cataract surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santé Atlantique

Saint-Herblain, France

RECRUITING

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 23, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

FR(1)