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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Treated with REVISYON SDS 100 Device
Lens-L Ltd
Liepāja, Latvia
Dr.Solomatina Acu Centrs
Riga, Latvia
Zielmelkurzeme Regional Hospital
Ventspils, Latvia
Change in Visual Acuity
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.
Time frame: 4 weeks
Change in Cataract Severity
Change in Cataract Severity, assessed using LOCS III
Time frame: 4 weeks
Subjective satisfaction using Visual Function Index
Subjective satisfaction, assessed using Visual Function Index (VF-14). The total result per subject is divided by the maximum possible result, excluding questions marked as "N/A," to determine the differences between the VF-14 result at Visit 1 and the VF-14 result at Visit 10. Higher scores mean a better outcome
Time frame: 4 weeks
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