Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
NCT01307527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2011-03-03
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.
Conditions
- Brittle Cornea Syndrome
- Ehlers-Danlos Syndrome Type 6
Interventions
- DRUG
-
Riboflavin
0.1%, applied every 5 minutes for 60 minutes
- DEVICE
-
Kera-X
3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes
Sponsors & Collaborators
-
Hadassah Medical Organization
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Israel
Study Locations
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