Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-28 @ 6:47 AM
Study NCT ID:
NCT01370850
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation Study of RTVue Features
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-09', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retina measurement', 'timeFrame': 'at time of study visit (day 1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retina pathology'], 'conditions': ['Healthy', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.', 'detailedDescription': 'Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers with various ocular pathology or no ocular pathology', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal subjects will have normal results from the clinical exam and be free of ocular pathology.\n* Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.\n* Retina patients will have clinical exam results consistent with retina pathology.\n\nExclusion Criteria:\n\n* Normal subjects will be free of any ocular pathology.\n* Glaucoma patients will be free of any ocular pathology except glaucoma.\n* Retina patients will be free of any ocular pathology except any type of retina pathology.'}, 'identificationModule': {'nctId': 'NCT01370850', 'briefTitle': 'Clinical Validation Study of RTVue Features', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'Clinical Validation Study of RTVue Features', 'orgStudyIdInfo': {'id': 'RTVue Validation Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'Normal results from the clinical exam and free of ocular pathology.'}, {'label': 'Glaucoma', 'description': 'Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.'}, {'label': 'Retina', 'description': 'Clinical exam results consistent with retina pathology.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94015', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Eye Specialists', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}], 'overallOfficials': [{'name': 'Mike Sinai, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Optovue'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mike Sinai, PhD / Director of Clinical Affairs', 'oldOrganization': 'Optovue'}}}}