Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-01 @ 7:50 AM
Study NCT ID:
NCT02555995
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance between ILM and RPE (IPD) measurement successful or not. Successful is defined as a) measurement performed/failed, and if performed, b) value obtained within ±10% of value of reference OCT device.', 'timeFrame': 'During diagnostic intervention, expected to be ca. 30 minutes on average'}], 'secondaryOutcomes': [{'measure': 'Patient comfort during examination', 'timeFrame': 'Directly after diagnostic intervention, expected to be ca. 35 minutes on average', 'description': 'Assessed via interview with patient'}, {'measure': 'Duration of OCT examination with investigational device', 'timeFrame': 'Directly after diagnostic intervention, expected to be ca. 35 minutes on average'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AMD', 'OCT'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).\n\nThis study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.\n\nIn this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.\n\nThe findings of this study are used to improve the software and the ergonomics of the investigational device.', 'detailedDescription': 'Background\n\nOptical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).\n\nThis study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.\n\nIn this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.\n\nThe findings of this study are used to improve the software and the ergonomics of the investigational device.\n\nObjective\n\n* Comparing scan quality of investigational device to scan quality of reference device.\n* Obtaining patient feedback on the examination with investigational device.\n\nMethods\n\nComparison of OCT scans made with standard device and investigational device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* German speaking\n* Suffering from age-related macular degeneration\n* Written informed consent\n\nExclusion Criteria\n\n* Epilepsy\n* Parkinsonian syndrome\n* Dementia\n* Pregnant women\n* Persons using electronic medical aids i.e. hearing aid, pacemaker..'}, 'identificationModule': {'nctId': 'NCT02555995', 'briefTitle': 'Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2015-0316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All study participants', 'description': "Patient's eyes are OCT-scanned with standard device and investigational device.", 'interventionNames': ['Device: OCT scan (as yet unnamed)']}], 'interventions': [{'name': 'OCT scan (as yet unnamed)', 'type': 'DEVICE', 'description': 'OCT scan (as yet unnamed) of the eye with investigational device; newly developed sparse OCT retina scanner by Artorg Center Bern and Berner Fachhochschule Biel', 'armGroupLabels': ['All study participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8006', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Augenklinik Univestitätspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Sandrine Zweifel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augenklinik Universitätspital Zürich'}, {'name': 'Raphael Sznitman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ARTORG, University of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}, {'name': 'ISS AG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}