NCT05396547

Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Edinburgh Biosciences Ltd · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.

Detailed description

This single arm, unmasked study will evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract. Only one of the subject's eyes will be treated with the REVISYON SDS 100 Device during the study (blue light treatment beam: Visit 1: 15 minutes, Visits 2 - 9: 20 minutes). The Treatment period will last 19 days (+ 1 day), starting with the day of first treatment (Visit 1, day 1). During this period, subjects will be treated with the REVISYON SDS 100 investigational device three-times a week for 3 weeks (Visit 1 to Visit 9) up to a maximum of 20 days (or 2.9 weeks). The Treatment period will be followed by 84 days (± 10 days) of follow up, up to a maximum of 94 days (or 13.4 weeks). The subject's eyes will be examined throughout the study to allow safety and performance to be monitored. The safety examinations includes standard ophthalmological tests. Clinical assessments in the study will use traditional ophthalmic methods including LogMAR best corrected visual acuity (BCVA) for distance, and grading of cataracts using LOCS III. In addition, spectral data (fluorescent emission) will be collected using the REVISYON SDS 100 Device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses.

Conditions

• Age-related Cataract

Interventions

Type	Name	Description
DEVICE	Treated with REVISYON SDS 100 Device	Treated with REVISYON SDS 100 Device

Timeline

• Start date: 2022-06-28
• Primary completion: 2025-01-04
• Completion: 2025-02-02
• First posted: 2022-05-31
• Last updated: 2025-11-24

Locations

11 sites across 3 countries: Latvia, Lithuania, Romania