Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT02700750
Status:
UNKNOWN
Last Update Posted:
2016-03-07
First Post:
2016-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2016-02-21', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between quality grading and retinal and RNFL thickness', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nerve Fiber Bundle Defect']}, 'descriptionModule': {'briefSummary': "The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.\n\nCollected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.", 'detailedDescription': "The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.\n\nCollected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: At least 20/30 visual acuity (BCVA), refractive error less than ±6 diopters (D) spherical equivalent or 3 D of astigmatism, and normal-appearing optic nerve head and retina on dilated fundus examination.\n\nExclusion Criteria:\n\n* Any history or evidence of eye disease or surgery.\n* Intraocular pressure (IOP) more than 22 mm Hg.'}, 'identificationModule': {'nctId': 'NCT02700750', 'briefTitle': 'Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT', 'orgStudyIdInfo': {'id': '294-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OCT exam', 'description': 'OCT exam No Arm No Intervention', 'interventionNames': ['Device: OCT exam']}], 'interventions': [{'name': 'OCT exam', 'type': 'DEVICE', 'description': 'OCT exam', 'armGroupLabels': ['OCT exam']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Ori Segal', 'investigatorAffiliation': 'Meir Medical Center'}}}}