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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT01307527

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brittle Cornea Syndrome Ehlers-Danlos Syndrome Type 6	Drug: Riboflavin Device: Kera-X	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Outcome Measures

Primary Outcome Measures

Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI [3 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult Patient with:

Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and
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