Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

Study Overview
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Brief Summary
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The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.

Official Title
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Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia

Conditions
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Keratoconus, Corneal Ectasia

Intervention / Treatment
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* Drug: Riboflavin 0.1% ophthalmic solution
* Device: CCL-VARIO UV lamp
* Device: CCL-VARIO at 18 mW/cm2


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria Prospective subjects must meet all of the following criteria to be eligible for participation: 18 years of age or older Signed written informed consent Willingness and ability to comply with schedule for follow-up visits Contact lens removal prior to evaluation and treatment Inclusion criteria for progressive keratoconus Prospective subjects must meet two of the following criteria: Having a diagnosis of progressive keratoconus: An increase of ≥ 1.00 D in the steepest keratometry value An increase of ≥ 1.00 D in astigmatism manifest refraction A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction Presence of central or inferior steepening on the Pentacam map. Axial topography consistent with keratoconus Steepest keratometry (Kmax) value ≥ 47.00 D Inclusion criteria for ectasia Prospective subjects must meet the following criteria: History of having undergone a keratorefractive procedure Meeting two of the following criteria Steepening by topography, either Pentacam or Humphrey Thinning of cornea Shift in the position of thinnest portion of cornea Change in refraction with increasing myopia Development of myopic astigmatism Development of irregular astigmatism Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria Subjects meeting any of the following criteria will be excluded from this protocol: Eyes classified as either normal, atypical normal, Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye to be treated A history of chemical injury or delayed epithelial healing in the eye to be treated. Pregnancy (including plan to become pregnant) or lactation during the course of the study A known sensitivity to study medications Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment Inability to cooperate with diagnostic tests. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 9 mW/cm2<br>CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution | Drug: Riboflavin 0.1% ophthalmic solution<br>* Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.<br>* Other names: crosslinking;Device: CCL-VARIO UV lamp<br>* Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes<br>* Other names: crosslinking;|
| Active Comparator: 18 mW/cm2<br>CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution | Drug: Riboflavin 0.1% ophthalmic solution<br>* Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.<br>* Other names: crosslinking;Device: CCL-VARIO at 18 mW/cm2<br>* Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.<br>* Other names: crosslinking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in maximum corneal curvature |  | 3 and 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratoconus, collagen crosslinking, crosslinking, ectasia