Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Phase 2
Completed
- Conditions
- Progressive KeratoconusCorneal Ectasia
- Interventions
- Procedure: Corneal collagenProcedure: Sham comparator
- Registration Number
- NCT00567671
- Lead Sponsor
- Emory University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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 the keratoconus group
- Corneal scarring
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Corneal collagen Corneal collagen cross-linking Control Sham comparator Sham Treatment
- 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 (1)
Woolfson Eye Institute
🇺🇸Atlanta, Georgia, United States