Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Study Overview
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Brief Summary
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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

Official Title
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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Conditions
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Keratoconus, Ectasia, Degeneration

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


Participation Criteria
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Eligibility Criteria
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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. Terrien's Marginal Degeneration Ability to provide written informed consent Likely to complete all study visits Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment. 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
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ciprofloxicine or Vigamox or other.<br> | Drug: Ciprofloxicine or Vigamox or other.<br>* Ciprofloxicine or Vigamox or other to be used qid till epithelialized.<br>|
| Nonsteroidal (Acular, Voltaren Xibrom, etc)<br> | Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)<br>* Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for 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 for 8 weeks.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration