Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00776451
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2008-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usability of the PreView PHP for Home Use in Intermediate AMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2008-10-20', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects who successfully completed the test by themselves, in a home simulated environment', 'timeFrame': '2 clinic visits'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AMD'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.notalvision.com', 'label': 'sponsor web site'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.', 'detailedDescription': 'The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dry AMD subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye\n* Age ≥65 years\n* VA with habitual correction better than 20/60 in the study eye\n* Ability to speak, read and understand instructions in English or Hebrew\n* Qualified to use the device by health care professional\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 or macular 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': 'NCT00776451', 'briefTitle': 'Usability of the PreView PHP for Home Use in Intermediate AMD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients', 'orgStudyIdInfo': {'id': 'PHP-US-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects diagnosed with Dry AMD'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Belinson Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Neil Bressler, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JHMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Osnat Ehrman', 'oldOrganization': 'Notal Vision'}}}}