Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT04569318
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2020-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device
Sponsor:
Edinburgh Biosciences Ltd
Organization:
Study Overview
Official Title:
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: