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

Status:	Terminated
Conditions:	Ocular, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Ophthalmology
Healthy:	No
Age Range:	12 - Any
Updated:	10/14/2018
Start Date:	February 1, 2010
End Date:	February 3, 2017

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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.

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

We found this trial at

sites

TLC Laser Eye Center

Rockville, Maryland 20852

Principal Investigator: Marc Levy, OD

320

from 43215

Rockville, MD