McNeel Eye Center Corneal Crosslinking Study

Not Applicable

Active, not recruiting

• Conditions: Keratoconus
• Interventions: Device: Crosslinking using UV light of two different fluence rates

• Registration Number: NCT02921009
• Lead Sponsor: McNeel Eye Center

Brief 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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2022-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion Criteria

• Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Crosslinking at different fluence rates	Crosslinking using UV light of two different fluence rates	The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.

Primary Outcome Measures

Name	Time	Method
Post treatment topographic analysis of Crosslinked patients	One Year	Pre-treatment videokeratography will be compared to post treatment keratography at certain intervals up to one year. Overall flattening of corneal curvature will be a primary study item.

Secondary Outcome Measures

Name	Time	Method
Post Treatment Best Corrected Visual Acuity	One Year	Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.

Trial Locations

Locations (1)

McNeel Eye Center; 🇺🇸 Boise, Idaho, United States