Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 9:37 PM
Study NCT ID:
NCT01893359
Status:
TERMINATED
Last Update Posted:
2021-04-26
First Post:
2013-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
Sponsor:
Glaukos Corporation
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of LASIK With Cross-linking Performed With the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution) Compared to LASIK Alone for Hyperopia and Hyperopic Astigmatism
Status:
TERMINATED
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:
None
Brief Summary:
The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.
Detailed Description:
None
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?: