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

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ClinicalTrials.gov Identifier: NCT01307527
Recruitment Status : Unknown
Verified February 2011 by Hadassah Medical Organization.
Recruitment status was:  Enrolling by invitation
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI [ Time Frame: 3 Months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307527


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Responsible Party: Joshua Kruger, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01307527     History of Changes
Other Study ID Numbers: BTL-CXL-HMO-CTIL
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Syndrome
Corneal Diseases
Eye Abnormalities
Joint Instability
Skin Abnormalities
Disease
Pathologic Processes
Eye Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Congenital Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents