Corneal Ectasia, Progressive Keratoconus
Conditions
Keywords
keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
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.
Interventions
DRUGRiboflavin
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
DRUGPlacebo
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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Exclusion criteria
* Prior corneal surgery in keratoconus group * Corneal scarring * Pregnancy
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