Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

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Detailed Description

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Conditions

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Keratoconus and Ectasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CXL Treatment

All eyes to be treated with riboflavin and UV light

Group Type EXPERIMENTAL

Riboflavin

Intervention Type DRUG

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

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

Interventions

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Riboflavin

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

Intervention Type DRUG

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

Eligibility Criteria

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Inclusion Criteria

* 12 years of age or older
* Diagnosis of Keratoconus or Ectasia
* Central or Inferior steepening on the Pentacam map
* Topography consistent with Keratoconus or Ectasia
* BSCVA 20/20 or worse
* Removal of contact lenses for 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
* Corneal pachymentry equal to or greater and 400
* Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
* A history of chemical injury or delayed healing
* Pregnancy
* A known sensitivity to the study medications
* Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
* Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No