Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 1:06 PM
Study NCT ID:
NCT00816569
Status:
UNKNOWN
Last Update Posted:
2009-01-01
First Post:
2008-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthokeratology for Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-31', 'studyFirstSubmitDate': '2008-12-31', 'studyFirstSubmitQcDate': '2008-12-31', 'lastUpdatePostDateStruct': {'date': '2009-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected Visual acuity', 'timeFrame': 'After 1 month'}], 'secondaryOutcomes': [{'measure': 'Amount of change in corneal video-topography', 'timeFrame': 'At one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Orthokeratology', 'Keratoconus'], 'conditions': ['Orthokeratology', 'Keratoconus']}, 'descriptionModule': {'briefSummary': 'To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate Keratoconus\n* No apical scars\n\nExclusion Criteria:\n\n* Advanced Keratoconus\n* Apical scaring\n* Contact lens intolerance'}, 'identificationModule': {'nctId': 'NCT00816569', 'briefTitle': 'Orthokeratology for Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Orthokeratology Contact Lenses for Keratoconus', 'orgStudyIdInfo': {'id': 'dvleyes-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Keratoconus', 'description': 'One eye of Keratoconus patient', 'interventionNames': ['Device: Orthokeratology contact lenses']}], 'interventions': [{'name': 'Orthokeratology contact lenses', 'type': 'DEVICE', 'description': 'Wearing Orthokeratology lens in one eye of a keratoconus patient', 'armGroupLabels': ['Keratoconus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': ': Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '00 972 2 6776095'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}, {'name': 'David Landau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': ': Hadassah Medical Organization,', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'David Landau, MD', 'role': 'CONTACT', 'email': 'dvl_eyes@slimail.com', 'phone': '00 972 54 4807077'}, {'name': 'Boris Savernski, OD', 'role': 'CONTACT', 'email': 'bopt@bezeqint.net', 'phone': '00 972 2 6777111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'David Landau MD', 'oldOrganization': ': Hadassah Medical Organization, Jerusalem, Israel'}}}}