Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.

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Detailed Description

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Conditions

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Brittle Cornea Syndrome Ehlers-Danlos Syndrome Type 6

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Riboflavin

0.1%, applied every 5 minutes for 60 minutes

Intervention Type DRUG

Kera-X

3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Adult Patient with:

1. Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and
2. Either:

* Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or
* Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma