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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CXL Treatment

Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.

Group Type EXPERIMENTAL

The VEGA UV-A Illumination System

Intervention Type DEVICE

This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

Riboflavin

Intervention Type DRUG

Riboflavin is a solution that will be delivered to the treatment area

Sham Control

Eyes in the control group will be treated with riboflavin only.

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

Riboflavin is a solution that will be delivered to the treatment area

Interventions

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The VEGA UV-A Illumination System

This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

Intervention Type DEVICE

Riboflavin

Riboflavin is a solution that will be delivered to the treatment area

Intervention Type DRUG

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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No