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

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT00567671

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Progressive Keratoconus Corneal Ectasia	Procedure: Corneal collagen Procedure: Sham comparator	Phase 2/Phase 3

Detailed Description

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.

Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Corneal collagen cross-linking	Procedure: Corneal collagen Corneal collagen cross-linking with riboflavin/UVA light
Sham Comparator: Control Sham Treatment	Procedure: Sham comparator Sham treatment

Arm

Intervention/Treatment

Experimental: Treatment

Corneal collagen cross-linking

Procedure: Corneal collagen

Corneal collagen cross-linking with riboflavin/UVA light

Sham Comparator: Control

Sham Treatment

Procedure: Sham comparator

Sham treatment

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:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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