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

NCT07246915 | Enrolling By Invitation

• 2 other identifiers: EB-CE-02QM75-OSP-001
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Keywords

REVISYON SDS 100; Visual acuity; EB-CE-02; EB-CE-01; Long-term safety; Non-interventional; Extension study; Cataract; Vision loss; LEDINBIO CE Device; Age-related Cataract

Outcome Measures

Primary Outcomes (1)

• A summary of adverse events

  A summary of adverse events collected over an average of 20 months following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation. The types of adverse events to be collected (AEs, SADEs, USADEs, AESIs, and SAEs) will be classified by type, severity, outcome, seriousness and causality).

  An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),

Secondary Outcomes (3)

• The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale

  An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),

• Preservation of the cataract severity grade, assessed using LOCS III grading scale for nuclear domain beyond 3 months

  An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),

• Subjective assessment of Visual function and Quality-of-life will be defined by the Visual Function Index-14 (VF-14) questionnaire data collected an average 20 months following the end of treatment with the medical device initiated in the EB-CE-01 study

  An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult subjects, affected by vision loss due to early-stage cataract who had been assessed for BCVA and LOCS III nuclear grade and underwent treatment during the EB-CE-01 clinical investigation

You may qualify if:

• Subjects who have initiated the EB-CE-01 study treatment phase in Romania
• Availability of complete retrospective data from the EB-CE-01 study- specifically from visit 12 assessment- including binocular BCVA, binocular LOCS III assessments, binocular slit-lamp assessment, and baseline assignment of the study eye.
• Be able and willing to follow instructions
• Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study. Note: Subjects who underwent cataract surgery in either eye will be allowed to participate

You may not qualify if:

• Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalised by court or official order, or in a dependency relationship with sponsor, testing centre or investigator.
• Subject involved in other clinical investigation that may compromise the results of the study.
• Subjects developing mental illnesses that can influence their participation in the study (cognitive impairment, psychiatric condition, or neurological disorder).
• Any health condition which could interfere with the subject's ability to comply with the study.

Sponsors & Collaborators

• Edinburgh Biosciences Ltd: lead
• MDX Research: collaborator

Study Sites (6)

Institutul Clinic de Urgențe Oftalmologice Prof. Dr. Mircea Olteanu

Bucharest, Romania

Location

Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila

Cluj-Napoca, Romania

Location

Dr. Berghian Ophthalmology Clinic

Timișoara, Romania

Location

Opticlass Clinic

Timișoara, Romania

Location

Romania Clinica Vista, Ophtalmology Department

Timișoara, Romania

Location

Spitalul Clinic CF Timisoara, Ophthalmology Department

Timișoara, Romania

Location

Related Links

• This is the website of Edinburgh Biosciences, the company sponsoring the clinical studies of the Revisyon medical device.

MeSH Terms

Conditions

Vision Disorders; Cataract

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases

Study Officials

• Trevor Shields

  Edinburgh Biosciences

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: October 28, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RO (6)