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

Not Applicable

• Conditions: Brittle Cornea Syndrome; Ehlers-Danlos Syndrome Type 6

• Registration Number: NCT01307527
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-02
• Last Update Submitted: 2011-03-02
• Study First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

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Exclusion Criteria

• Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI	3 Months

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel