Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT00674661
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2008-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corneal Collagen Cross-Linking for Ectasia (CXL)
Sponsor:
Glaukos Corporation
Organization:
Study Overview
Official Title:
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
Detailed Description:
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: