CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.

Official Title
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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Conditions
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Keratoconus

Intervention / Treatment
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* Other: Theralight crosslinking and Riboflavin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8 years of age or older Having at least one of the following conditions: Keratoconus Post-LASIK ectasia Pellucid marginal degeneration Forme fruste pellucid marginal degeneration FFKC History of Radial Keratotomy with fluctuating vision. Terrien's Marginal Degeneration Signed written informed consent and/or assent Likely to complete all study visits Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Theralight crosslinking and Riboflavin<br>ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin | Other: Theralight crosslinking and Riboflavin<br>* Corneal Collagen cross linking with UV light and riboflavin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Spectacle Corrected Visual Acuity (BSCVA) |  | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Uncorrected Visual Acuity (UCVA) |  | 6-9 months | 
| Change in Corneal topography |  | 6-9 months | 
| Change in Manifest Refraction |  | 6-9 months | 
| Change in Keratometry on topography and Pentacam |  | 6-9 months | 
| Change in Wavefront Refraction and aberrations |  | 6-9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration