Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897503
Status:
RECRUITING
Last Update Posted:
2023-01-04
First Post:
2021-05-18
Brief Title:
Corneal Collagen Crosslinking for Keratoconus and Ectasia Using RiboflavinDextran or RiboflavinMethylcellulose
Sponsor:
Cornea and Laser Eye Institute
Organization:
Cornea and Laser Eye Institute
Study Overview
Official Title:
Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using RiboflavinDextran or RiboflavinMethylcellulose
Status:
RECRUITING
Status Verified Date:
2022-12
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:
CXL
Brief Summary:
This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia will determine the safety and efficacy of corneal collagen crosslinking CXL performed with two different riboflavin formulations for reducing corneal curvature
Detailed Description:
This study will determine the safety and efficacy of corneal collagen crosslinking CXL performed with two different riboflavin formulations for reducing corneal curvature Subjects will be randomized to one of 2 groups One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution Both groups will be exposed to 3mWcm2 of continuous UVA light for a total of 30 minutes each group will continue to be administered the designated riboflavin drops during UV exposure
The primary efficacy parameter that will be evaluated over time is maximum keratometry Kmax in the randomized eyes for each treatment group
The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline
The primary efficacy parameter that will be evaluated over time is maximum keratometry Kmax in the randomized eyes for each treatment group
The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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