Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Study Overview
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Brief Summary
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This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

Detailed Description
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This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.

Official Title
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Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Conditions
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Keratoconus, Corneal Diseases, Eye Diseases, Photosensitizing Agents

Intervention / Treatment
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* Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of at least one of the following conditions: Keratoconus Forme fruste keratoconus Post-LASIK ectasia Pellucid marginal degeneration Forme fruste pellucid marginal degeneration Diurnal fluctuation post-radial keratotomy Terrien's marginal degeneration Exclusion Criteria: Corneal thickness < 375 microns measured by ultrasound or Pentacam. Contraindications or hypersensitivities to any study medications or their components. Pregnancy or breastfeeding. Any history of herpes simplex corneal disease in an eye to be treated. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. Inability to cooperate with diagnostic tests. Enrollment in another ophthalmic clinical trial.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes. | Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device<br>* CXLO Corneal Strengthening Solution<br>|
| Active Comparator: Group 2<br>Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes. | Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device<br>* CXLO Corneal Strengthening Solution<br>|
| Active Comparator: Group 3<br>Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes. | Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device<br>* CXLO Corneal Strengthening Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Corrected Distance Visual Acuity (CDVA) | Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline | Baseline and 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline | Baseline and 6 and 12 months | 
| Change From Baseline in Maximum Keratometry (KMax) | Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline. | Baseline and 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconus, Forme fruste keratoconus, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, Diurnal fluctuation post-radial keratotomy, Terrien's marginal degeneration