Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT03783858
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2018-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Image Collection of Normal Eyes for Development of an EU RDB
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal thickness', 'timeFrame': '1 day', 'description': 'In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters.\n\nThe 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject 22 years of age or older on the date of informed consent\n2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subject presenting at the site with normal eyes\\* (Cataracts and LASIK and PRK are allowed)\n4. BCVA 20/40 or better (each eye)\n5. Subject is able to comply with the study procedures in the view of the investigator \\*Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator\n\nExclusion Criteria:\n\n1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT03783858', 'briefTitle': 'Image Collection of Normal Eyes for Development of an EU RDB', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optos, PLC'}, 'officialTitle': 'Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database', 'orgStudyIdInfo': {'id': 'OPT1030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single', 'interventionNames': ['Device: P200TE']}], 'interventions': [{'name': 'P200TE', 'type': 'DEVICE', 'description': 'OCT images', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK40 2SR', 'city': 'Bedford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Simon Browning Optometrist', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}, {'zip': 'NW11 7EL', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Barnard Levit Optometrists', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G 7LA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'London Vision Clinic', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'BT7 1NN', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Queens University', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'EH3 6SW', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Cameron Optometry', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Tunde Peto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queens University Belfast'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optos, PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}