Single arm proof-of-concept trial to evaluate the safety and efficacy of the REVISYON PoC Device in the treatment of cataract.
Single arm, single site proof-of-concept trial to evaluate the safety and efficacy of the REVISYON PoC Device, with 8 x 15-minute twice-weekly treatments and 3 month safety follow-up, in the treatment of cataract. Only one of the subject's eyes will be treated during the study. In addition, spectral data (fluorescent emission) will be collected using the 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
11
One of the subject's eyes will be treated with the treatment beam (20mW) up to 8 times for 15 minutes.
Dr.Solomatina Acu Centrs
Riga, Latvia
Safety: assessed by changes in the Local Ocular Tolerability (LOT) Visual Analogue Scale (VAS)
Assessment of safety defined as changes in the LOT VAS. A self-administered 7-item (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia) 100 mm VAS on which 0 means no symptoms and 100 means the worst possible discomfort. VAS Ocular Tolerability Overall score is the mean of all VAS Ocular Tolerability symptom scores per visit per eye
Time frame: 20 weeks
Efficacy: Cataract Grade
Assessment of efficacy, defined as treating cataract assessed using Lens Opacities Classification System (LOCS) III. Higher scores mean a worse outcome.
Time frame: 5 weeks
Change in cataract severity
Assessed using Objective Scatter Index (OSI) using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Time frame: 5 weeks
Change in visual acuity
Assessed using LogMAR (Logarithm of the Minimum Angle of Resolution) scale. Higher scores mean a worse outcome.
Time frame: 5 weeks
Change in light scatter
Assessed using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Time frame: 5 weeks
Change in functional impairment due to cataract
Assessed using VF-14 (Visual Function Index) questionnaire data. Higher scores mean a better outcome.
Time frame: 5 weeks
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