Overview

Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Status:
Terminated
Trial end date:
2017-02-03
Target enrollment:
0
Participant gender:
All
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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cxlusa
Treatments:
Bromfenac
Diclofenac
Fluorometholone
Ketorolac
Ketorolac Tromethamine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- 12 years of age or older

- Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration
or forme fruste pellucid marginal degeneration (FFPMD).

- 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

- At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

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