Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-21 @ 1:56 PM
Study NCT ID:
NCT02422160
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration
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': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Two Years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': "The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-exudative age-related macular degneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-exudative age-related macular degeneration\n\nExclusion Criteria:\n\n* Exudative age-related macular degeneration'}, 'identificationModule': {'nctId': 'NCT02422160', 'briefTitle': 'Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': '33624'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No interventions are planned', 'type': 'OTHER', 'description': 'No interventions are planned'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Theodore Leng', 'investigatorAffiliation': 'Stanford University'}}}}