Trials / Completed
CompletedNCT04569318
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Edinburgh Biosciences Ltd · Industry
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Single arm proof-of-concept trial to evaluate the safety and efficacy of the REVISYON PoC Device in the treatment of cataract.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Treatment Beam | One of the subject's eyes will be treated with the treatment beam (20mW) up to 8 times for 15 minutes. |
Timeline
- Start date
- 2020-10-19
- Primary completion
- 2021-08-19
- Completion
- 2021-09-09
- First posted
- 2020-09-29
- Last updated
- 2025-11-24
Locations
1 site across 1 country: Latvia
Source: ClinicalTrials.gov record NCT04569318. Inclusion in this directory is not an endorsement.