CXL: Corneal Crosslinking in Keratoconus and Corneal Ectasia

Sponsor

Ohio State University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00679666

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Progressive Keratoconus Corneal Ectasia	Drug: Riboflavin Drug: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham treatment 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.	Drug: Placebo Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
Active Comparator: Treatment Arm After randomization, the active arm will have the collagen crosslinking intervention.	Drug: Riboflavin 01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes Other Names: Vitamin B2

Arm

Intervention/Treatment

Sham Comparator: Sham treatment

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.

Drug: Placebo

Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.

Active Comparator: Treatment Arm

After randomization, the active arm will have the collagen crosslinking intervention.

Drug: Riboflavin

01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes

Other Names:

Vitamin B2

Outcome Measures

Primary Outcome Measures

change in keratometry [3 months]

Secondary Outcome Measures

best spectacle-corrected visual acuity [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.