CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-02-03

Brief Summary

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The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.

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Detailed Description

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This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.

Conditions

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Theralight crosslinking and Riboflavin

ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin

Group Type OTHER

Theralight crosslinking and Riboflavin

Intervention Type OTHER

Corneal Collagen cross linking with UV light and riboflavin

Interventions

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Theralight crosslinking and Riboflavin

Corneal Collagen cross linking with UV light and riboflavin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 8 years of age or older
2. Having at least one of the following conditions:

* Keratoconus
* Post-LASIK ectasia
* Pellucid marginal degeneration
* Forme fruste pellucid marginal degeneration
* FFKC
* History of Radial Keratotomy with fluctuating vision.
* Terrien's Marginal Degeneration
3. Signed written informed consent and/or assent
4. Likely to complete all study visits
5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria

1. Severe corneal scarring that markedly affects vision
2. Contraindications to any study medications or their components
3. Pregnancy or breast feeding
4. Active Herpes Corneal Disease

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No