Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-22 @ 7:16 AM
Study NCT ID:
NCT01073592
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2010-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Foresee Home and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size and location of lesions', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HMP', 'CNV', 'AMD', 'PHP', 'HPHP', 'FORESEE HOME'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.notalvision.com', 'label': 'sponsor web site'}]}, 'descriptionModule': {'briefSummary': 'The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.\n\nThe OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.\n\nThe Foresee Home can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects suspected to have CNV secondary to 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 with CNV\n* Did not perform more then 4 anti- VGEF injections\n* VA with habitual correction better then 6/45 in the study eye\n* Ability to understand instructions\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,\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'}, 'identificationModule': {'nctId': 'NCT01073592', 'briefTitle': 'Comparison Between Foresee Home and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'Comparison Between Home Macular Perimeter (FORESEE HOME) and OCT Visual Field Defects in Patients With CNV', 'orgStudyIdInfo': {'id': 'FORESEE HOME-POST-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CNV patiens'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Ruth Siegal, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}