Corneal Crosslinking in Keratoconus and Corneal Ectasia

Phase 2

Withdrawn

• Conditions: Progressive Keratoconus; Corneal Ectasia
• Interventions: Drug: Placebo; Drug: Riboflavin

• Registration Number: NCT00679666
• Lead Sponsor: Ohio State University

Brief Summary

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

Detailed Description

After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Primary Completion: 2010-04
• Study Completion: 2010-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of keratoconus with documented progression over the previous 12 months.
• Diagnosis of corneal ectasia
• Must be able to complete all study visits.

Exclusion Criteria

• Prior corneal surgery in keratoconus group
• Corneal scarring
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham treatment	Placebo	Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.
Treatment Arm	Riboflavin	After randomization, the active arm will have the collagen crosslinking intervention.

Primary Outcome Measures

Name	Time	Method
change in keratometry	3 months

Secondary Outcome Measures

Name	Time	Method
best spectacle-corrected visual acuity	3 months

Trial Locations

Locations (2)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

OSU Havener Eye Institute; 🇺🇸 Dublin, Ohio, United States