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