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

NCT07362043 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 446

Last updated 2026-01-30

No results posted yet for this 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.

Conditions

  • Cataract Surgery

Interventions

DEVICE

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

Sponsors & Collaborators

  • Santé Atlantique - Saint-Herblain - France

    collaborator UNKNOWN

  • Helix Surgical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2028-01-31
Completion
2028-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362043 on ClinicalTrials.gov