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

Study Overview
=================
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. 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.

Official Title
-----------------
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Conditions
-----------------
Keratoconus, Ectasia, Degeneration

Intervention / Treatment
-----------------
* Drug: Ciprofloxicin or Vigamox or other.
* Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
* Drug: Steroid (FML, Pred Forte, Flarex, etc.)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ciprofloxicin or Vigamox or other.<br> | Drug: Ciprofloxicin or Vigamox or other.<br>* Ciprofloxicin or Vigamox or other to be used qid till epithelialized.<br>|
| Nonsteroidal (Acular, Voltaren Xibrom, etc)<br> | Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)<br>* Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op<br>|
| Steroid (FML, Pred Forte, Flarex, etc.)<br> | Drug: Steroid (FML, Pred Forte, Flarex, etc.)<br>* Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin |  | 1 year |