- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307527
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
March 2, 2011 updated by: Hadassah Medical Organization
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Hadassah Medical Organization
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI
Time Frame: 3 Months
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 1, 2011
First Submitted That Met QC Criteria
March 2, 2011
First Posted (Estimate)
March 3, 2011
Study Record Updates
Last Update Posted (Estimate)
March 3, 2011
Last Update Submitted That Met QC Criteria
March 2, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Hemostatic Disorders
- Skin Diseases, Genetic
- Collagen Diseases
- Syndrome
- Skin Abnormalities
- Joint Instability
- Corneal Diseases
- Ehlers-Danlos Syndrome
- Eye Abnormalities
- Physiological Effects of Drugs
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Vitamin B Complex
- Riboflavin
Other Study ID Numbers
- BTL-CXL-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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