Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)

Sponsor
Edinburgh Biosciences Ltd
Study ID
NCT07246915
Status
Enrolling By Invitation

Conditions

  • Age-related Cataract
  • Cataract
  • Mild Cataract
  • Moderate Cataract
  • Vision Loss

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Study Details

A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.

Key Dates

First listed
Nov 24, 2025
Start date
Oct 28, 2025
Status verified
Nov 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
61 participants (estimated)

Arms

  • Arm: Study Population
    The study population will consist of adult subjects with vision loss due to mild or moderate cataract, who were previously treated with the medical device in the EB-CE-01 study (one eye only, recorded as the study eye). The exclusion criteria are intended to protect subject safety and to ensure the integrity and validity of the clinical investigation by excluding subjects for whom participation may present undue risk.

Primary Outcome Measure

A summary of adverse events [ Time Frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation), ]

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