NCT01893359

Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperopia
• Hyperopic Astigmatism

Interventions

Type	Name	Description
DRUG	riboflavin ophthalmic solution, 0% dextran
DEVICE	UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
DEVICE	UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
PROCEDURE	Laser-assisted in situ keratomileusis

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-02-01
• Completion: 2016-04-01
• First posted: 2013-07-09
• Last updated: 2021-04-26
• Results posted: 2016-10-24

Locations

5 sites across 1 country: United States