Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569318
Status:
TERMINATED
Last Update Posted:
2021-10-04
First Post:
2020-09-17
Brief Title:
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Sponsor:
Edinburgh Biosciences Ltd
Organization:
Edinburgh Biosciences Ltd
Study Overview
Official Title:
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study objectives met
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 LEDINBIO 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 LEDINBIO 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 subjects 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 subjects 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:
None
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?:
None