Degeneration, Ectasia, Keratoconus
Conditions
Keywords
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
Brief summary
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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication
Interventions
None listed
Sponsors
Cxlusa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 8 years of age or older * Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration. * Diagnosis of FFKC * History of Radial Keratotomy with fluctuating vision. * Ability to provide written informed consent * Likely to complete all study visits * Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam
Exclusion criteria
* Severe corneal scarring that markedly affects vision * Contraindications to any study medications or their components * Pregnancy or breast feeding * Active Herpes Corneal Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin | 1 year |
Countries
United States
Outcome results
None listed