Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:45 PM
Study NCT ID:
NCT01307527
Status:
UNKNOWN
Last Update Posted:
2011-03-03
First Post:
2011-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536192', 'term': 'Brittle cornea syndrome 1'}, {'id': 'C536198', 'term': 'Ehlers-Danlos syndrome type 6'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012256', 'term': 'Riboflavin'}], 'ancestors': [{'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-03-02', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI', 'timeFrame': '3 Months'}]}, 'conditionsModule': {'conditions': ['Brittle Cornea Syndrome', 'Ehlers-Danlos Syndrome Type 6']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult Patient with:\n\n1. Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and\n2. Either:\n\n * Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or\n * Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma\n\nExclusion Criteria:\n\n* Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure'}, 'identificationModule': {'nctId': 'NCT01307527', 'briefTitle': 'Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'BTL-CXL-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Riboflavin', 'type': 'DRUG', 'description': '0.1%, applied every 5 minutes for 60 minutes'}, {'name': 'Kera-X', 'type': 'DEVICE', 'description': '3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joshua Kruger', 'oldOrganization': 'Hadassah Medical Center'}}}}