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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract; Age-related Cataract; Vision Loss; Mild Cataract; Moderate Cataract

Detailed Description

This study is an ancillary study to the EB-CE-01 clinical investigation. No treatment or any study-specific intervention is foreseen for the study subcohort. This study is designed to evaluate the maintenance of safety and efficacy an average 20 months following the end of treatment of mild-to-moderate senile cataract with the medical device in the EB-CE-01 clinical investigation in the Romanian subcohort of subjects. Due to the long enrolment gap and different treatment intervals, the tracking of subjects provided a significant difference in the intervals since treatment completion among subjects.

Therefore, the study approach involves a single additional visit for subjects who initiated treatment, during which supplementary data will be collected from standard-of-care ophthalmological assessments.

In the initial EB-CE-01 study, treatment with the non-invasive medical device REVISYON SDS 100 was administered between April 2023 and December 2024 to 92 patients, all of whom were included in both the Full Analysis Set and the Safety Set. Best corrected visual acuity (BCVA) was assessed at 7 (±1) days, 28 (±4) days, and 84 (±10) days following the final treatment session (known as Visit 9). Treatment efficacy was evaluated at 7 (±1) days only, corresponding to one-week post-treatment.

In this extension study, prospective data will be collected to assess the incidence of any safety events and to evaluate the maintenance of best-corrected visual acuity (BCVA), cataract severity grade, and visual functioning at an additional follow-up visit. The following timepoints from the parent study will be used as reference: EB-CE-01 V0 (pre-treatment), EB-CE-01 V1-V9 (treatment visits), and EB-CE-01 V12 (last efficacy visit), which will serve as the baseline for the current extension study.

The main objective of the study is capturing any new clinically significant findings that meet the definition of an AE in accordance with EU MDR 2017/745 and ISO 14155:2020, as to generate robust safety findings in the pre-market stage.

As secondary objectives, the study will assess the mean change in best-corrected visual acuity (BCVA), the preservation of cataract severity grade, and the subjective evaluation of visual function using The Visual Function Index-14 (VF-14) relative to the last post-treatment assessment, defined at Visit 12 of the EB-CE-01 clinical investigation.

Study participants will be required to provide additional answers related to the visual functioning (VF-14 questionnaire), which will be administered in Romanian using linguistically validated versions. VF-14 questionnaire is a validated, brief questionnaire, including self-reported measures, designed to be completed within a few minutes, and is therefore not expected to constitute a burden or interfere with routine clinical care.

• Study Type: Observational
• Enrollment (Estimated): 61

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Institutul Clinic de Urgențe Oftalmologice Prof. Dr. Mircea Olteanu
  • Cluj-Napoca, Romania
    • Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila
  • Timișoara, Romania
    • Dr. Berghian Ophthalmology Clinic
  • Timișoara, Romania
    • Opticlass Clinic
  • Timișoara, Romania
    • Romania Clinica Vista, Ophtalmology Department
  • Timișoara, Romania
    • Spitalul Clinic CF Timisoara, Ophthalmology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale	Change in LogMAR = LogMAR (extended visit) - LogMAR (Visit 12, 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),
Preservation of the cataract severity grade, assessed using LOCS III grading scale for nuclear domain beyond 3 months	Change in LOCS III = LOCS III (extended visit) - LOCS III (Visit 12, 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),
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	Change in Visual Function Index-14 (VF-14) Total Score (range 0-100, with higher scores representing better visual function) and changes in each of the 14 item-level scores (each item scored 0-4, with higher scores indicating less difficulty) from Visit 12 (EB-CE-01 study) to the extended follow-up visit	An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),

Collaborators and Investigators

• Sponsor: Edinburgh Biosciences Ltd
• Collaborators: MDX Research
• Investigators: Study Director: Trevor Shields, Edinburgh Biosciences

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Long-term safety; Non-interventional; Visual acuity; Vision loss; Extension study; Age-related Cataract; REVISYON SDS 100; EB-CE-02; EB-CE-01; LEDINBIO CE Device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Sensation Disorders; Lens Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cataract; Vision Disorders
• Other Study ID Numbers: EB-CE-02; QM75-OSP-001 (Other Identifier: Edinburgh Biosciences Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No