Keratoconus
Conditions
Keywords
keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration
Brief summary
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.
Detailed description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
Interventions
OTHERTheralight crosslinking and Riboflavin
Corneal Collagen cross linking with UV light and riboflavin
Sponsors
Cxlusa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 8 years of age or older 2. Having at least one of the following conditions: * Keratoconus * Post-LASIK ectasia * Pellucid marginal degeneration * Forme fruste pellucid marginal degeneration * FFKC * History of Radial Keratotomy with fluctuating vision. * Terrien's Marginal Degeneration 3. Signed written informed consent and/or assent 4. Likely to complete all study visits 5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
Exclusion criteria
1. Severe corneal scarring that markedly affects vision 2. Contraindications to any study medications or their components 3. Pregnancy or breast feeding 4. Active Herpes Corneal Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best Spectacle Corrected Visual Acuity (BSCVA) | 6-9 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Uncorrected Visual Acuity (UCVA) | 6-9 months |
| Change in Corneal topography | 6-9 months |
| Change in Manifest Refraction | 6-9 months |
| Change in Keratometry on topography and Pentacam | 6-9 months |
| Change in Wavefront Refraction and aberrations | 6-9 months |
Countries
United States
Outcome results
None listed