Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 6:56 AM
Study NCT ID:
NCT03318705
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Latest Version of NidekRS3000Adv
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular vascularization', 'timeFrame': '1 year', 'description': 'Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Control subjects with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* 18 years old or older\n\nExclusion Criteria:\n\n* Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging\n* subjects who are unable to maintain retinal fixation on a specified target\n* subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place\n* subjects with media opacity which preclude high quality imaging will be excluded.\n* vulnerable subjects\n* subjects under 18\n* pregnant subjects\n* economically and educationally disadvantaged subjects\n* decision impaired subjects\n* homeless subjects'}, 'identificationModule': {'nctId': 'NCT03318705', 'briefTitle': 'Testing Latest Version of NidekRS3000Adv', 'organization': {'class': 'OTHER', 'fullName': 'Doheny Image Reading Center'}, 'officialTitle': 'Testing Latest Version of NidekRS3000Adv', 'orgStudyIdInfo': {'id': 'NIDEKRS3000ADV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RS3000Adv', 'type': 'DEVICE', 'description': 'Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Doheny Eye Centers UCLA', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Srinivas Sadda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doheny Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Doheny Image Reading Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Manager - Research', 'investigatorFullName': 'Kenneth Marion', 'investigatorAffiliation': 'Doheny Image Reading Center'}}}}