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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01307527
First received: March 1, 2011
Last updated: March 2, 2011
Last verified: February 2011
  Purpose

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 Intervention
Brittle Cornea Syndrome
Ehlers-Danlos Syndrome Type 6
Drug: Riboflavin
Device: Kera-X

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307527

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Joshua Kruger, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01307527     History of Changes
Other Study ID Numbers: BTL-CXL-HMO-CTIL
Study First Received: March 1, 2011
Last Updated: March 2, 2011
Health Authority: Israel: Ministry of Health - Director General

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Corneal Diseases
Eye Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014