Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00976235
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long-Term Monitoring Study of the IMT-002 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)', 'timeFrame': '5 years from implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Degeneration', 'Visual Impairment', 'Quality of Life', 'Telescope Prosthesis'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.', 'detailedDescription': 'Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have participated in the IMT-002 trial.\n* Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.\n* Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.\n\nExclusion Criteria:\n\n* Patients who have not participated in the IMT-002 trial.'}, 'identificationModule': {'nctId': 'NCT00976235', 'briefTitle': 'A Long-Term Monitoring Study of the IMT-002 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'VisionCare, Inc.'}, 'officialTitle': 'Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients', 'orgStudyIdInfo': {'id': 'IMT-002-LTM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMT', 'interventionNames': ['Device: IMT - Implantable Miniature Telescope']}], 'interventions': [{'name': 'IMT - Implantable Miniature Telescope', 'type': 'DEVICE', 'description': 'Implantation of the telescope prosthesis (performed under the initial study)', 'armGroupLabels': ['IMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Centers P.C.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94024', 'city': 'Los Altos', 'state': 'California', 'country': 'United States', 'facility': 'Altos Eye Physician', 'geoPoint': {'lat': 37.38522, 'lon': -122.11413}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Doheny Retina Institute - University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Retinal Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kraft Eye Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Paducah Retinal Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '21287-9277', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Ophthalmological Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Retina Group of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye & Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'W.K. Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55082', 'city': 'Stillwater', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Associated Eye Care', 'geoPoint': {'lat': 45.05636, 'lon': -92.80604}}, {'zip': '64055', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Discover Vision Centers', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Eye & Ear', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeast Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean A. McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Fine, Hoffman & Packer', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78240', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vitreoretinal Foundation', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VisionCare, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}