Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
Primary Purpose
Brittle Cornea Syndrome, Ehlers-Danlos Syndrome Type 6
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Riboflavin
Kera-X
Sponsored by
About this trial
This is an interventional prevention trial for Brittle Cornea Syndrome
Eligibility Criteria
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
Exclusion Criteria:
- Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI
Secondary Outcome Measures
Full Information
NCT ID
NCT01307527
First Posted
March 1, 2011
Last Updated
March 2, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01307527
Brief Title
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brittle Cornea Syndrome, Ehlers-Danlos Syndrome Type 6
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Intervention Description
0.1%, applied every 5 minutes for 60 minutes
Intervention Type
Device
Intervention Name(s)
Kera-X
Intervention Description
3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes
Primary Outcome Measure Information:
Title
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
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