Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT02198560
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2014-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RS-3000 Lite Agreement Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal thickness and Optic Disc Analysis', 'timeFrame': '3 hours', 'description': 'Time frame is the maximum duration of hospital stay.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '1day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal (Eyes without pathologies)'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal (Eyes without pathology)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who do not have pathology in both eyes\n\nExclusion Criteria:\n\nSubjects who have any of the following conditions:\n\n* Diabetes mellitus (DM) and/or diabetic retinopathy\n* Uncontrolled Hypertension (HT)\n* Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision\n* Cardiac, hepatic, renal and hematologic diseases\n* A current condition requiring systemic administration of steroid\n* A history of, or currently receiving, anticancer therapy\n* Epileptic seizures which are optically induced\n* Dementia\n\nNote: Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02198560', 'briefTitle': 'RS-3000 Lite Agreement Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nidek Co. LTD.'}, 'orgStudyIdInfo': {'id': 'NRL-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal (Eyes without pathology)', 'interventionNames': ['Device: RS-3000 Lite']}], 'interventions': [{'name': 'RS-3000 Lite', 'type': 'DEVICE', 'armGroupLabels': ['Normal (Eyes without pathology)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4440226', 'city': 'Okazaki', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nabeta Ganaka Iin', 'geoPoint': {'lat': 34.95, 'lon': 137.16667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nidek Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}