NCT02921009

McNeel Eye Center Corneal Crosslinking Study

Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: McNeel Eye Center · Industry
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Detailed description

Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DEVICE	Crosslinking using UV light of two different fluence rates	The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-12-01
• Completion: 2025-12-31
• First posted: 2016-09-30
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States