Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02535520
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2015-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of RTVue XR With SSADA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2015-08-26', 'studyFirstSubmitQcDate': '2015-08-27', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of SSADA to conventional angiography', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retina Vascular Pathology']}, 'descriptionModule': {'briefSummary': 'Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature. Consented subjects will undergo a series of images of the back of the eye using an Optical Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of clinical routine. SSADA images will be compared with conventional methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Seeing eye doctor for routine or follow-up care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Able and willing to complete exams\n* Patients in retina clinic that need angiography\n\nExclusion Criteria:\n\n* Unable to complete the required examinations and visits\n* Large amount of subretinal hemorrhage\n* Media opacity leading to poor quality images\n* Extreme refractive error leading to poor quality images\n* Pathologies in the anterior segment leading to poor quality images'}, 'identificationModule': {'nctId': 'NCT02535520', 'briefTitle': 'Evaluation of RTVue XR With SSADA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'Clinical Evaluation of RTVue XR With SSADA in Retinal Patients', 'orgStudyIdInfo': {'id': '200-50547'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}