Corneal Ectasia, Progressive Keratoconus
Conditions
Keywords
keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
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.
Interventions
PROCEDURECorneal collagen
Corneal collagen cross-linking with riboflavin/UVA light
PROCEDURESham comparator
Sham treatment
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in keratometry | 3 Months |
Secondary
| Measure | Time frame |
|---|---|
| Best spectacle-corrected visual acuity | 3 Months |
Countries
United States
Outcome results
None listed