Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-20 @ 3:45 PM
Study NCT ID:
NCT00603850
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2008-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who manage to use the device as in a daily testing', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HMP, PHP, AMD, CNV, HPHP'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.notalvision.com', 'label': 'Sponsor web Site'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.', 'detailedDescription': 'The pilot study purpose is to demonstrate that the tutorial which is a part of the device software, is giving sufficient training for the intended users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed as intermediate AMD in at least one eye', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable and willing to sign a consent form and participate in the study\n* Subjects diagnosed as intermediate AMD in at least one eye\n* Age \\>50 years\n* VA with habitual correction \\>20/60 in the study eye\n* Ability to speak, read and understand instructions in Hebrew\n* Familiar with computer usage\n\nExclusion Criteria:\n\n* Evidence of macular disease other than AMD or glaucoma in the study eye\n* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.\n* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye\n* Participation in another study with the exclusion of AREDS study\n* Patients diagnosed with geographic atrophy (GA)'}, 'identificationModule': {'nctId': 'NCT00603850', 'acronym': 'HMP', 'briefTitle': 'Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients', 'orgStudyIdInfo': {'id': 'HMP-PU3'}, 'secondaryIdInfos': [{'id': 'W121937330'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Intermediate AMD Patients', 'interventionNames': ['Device: ForeseeHome']}], 'interventions': [{'name': 'ForeseeHome', 'type': 'DEVICE', 'description': 'human factor', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose & Throat', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Justin Mr Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charlotte Eye Ear Nose & Throat'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}