Ectasia Corneal, Keratoconus
Conditions
Brief summary
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
Interventions
COMBINATION_PRODUCTriboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
COMBINATION_PRODUCTRiboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
Sponsors
Price Vision Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented keratoconus or ectasia after refractive surgery
Exclusion criteria
* Insufficient corneal thickness * Ocular condition that may predispose the eye to complications * History of chemical injury or delayed epithelial healing * Condition that would interfere with or prolong epithelial healing * Known sensitivity to treatment medications * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maximum keratometry | 6 months | assessed by corneal tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in corrected distance visual acuity | 6 months | assessed with Snellen chart |
| Change in uncorrected distance visual acuity | 6 months | assessed with Snellen chart |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrancis W Price, Jr., MD
Price Vision Group
Outcome results
None listed