Safety Study of the VEGA UV-A System to Treat Keratoconus

Study Overview
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Brief Summary
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The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.

Official Title
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Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus

Conditions
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Keratoconus

Intervention / Treatment
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* Device: The VEGA UV-A Illumination System
* Drug: Riboflavin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 years of age or older Having a diagnosis of keratoconus Presence of central or inferior steepening Topography consistent with keratoconus Presence of one or more slit lamp or retinoscopy findings associated with keratoconus Contact lens wearers only:Removal of contact lenses for the required period of time Signed written informed consent Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated Corneal pachymetry ≤ 400 microns Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision A history of chemical injury or delayed epithelial healing in the eye(s) to be treated. Pregnancy (including plan to become pregnant) or lactation during the course of the study A known sensitivity to study medications Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing. Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| Experimental: CXL Treatment<br>Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light. | Device: The VEGA UV-A Illumination System<br>* This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area<br>Drug: Riboflavin<br>* Riboflavin is a solution that will be delivered to the treatment area<br>|
| Active Comparator: Sham Control<br>Eyes in the control group will be treated with riboflavin only. | Drug: Riboflavin<br>* Riboflavin is a solution that will be delivered to the treatment area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corneal Curvature. |  | 6 Months |