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

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.

• The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),]