Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02631369
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020432', 'term': 'Trochlear Nerve Diseases'}], 'ancestors': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pre-study: reliability of repeated measurements of excyclotorsion in degrees on SLO-fundus fotographs', 'timeFrame': '3 months', 'description': 'pre-study: inter- and intrarater reliability of the device with or without eye tracker; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis'}, {'measure': 'study: excyclotorsion in degrees on SLO-fundus fotographs', 'timeFrame': '12 months', 'description': 'study: comparison of cyclotorsion measurements in healthy controls compared to patients with forth nerve palsy; excyclotorsion in degrees (based on the line crossing the fovea and the center of the optic nerve head) as provided by the integrated algorithm by Heidelberg Spectralis'}], 'secondaryOutcomes': [{'measure': 'study: excyclotorsion in degrees on tangent screen, double maddox and fundus photographs', 'timeFrame': '12 months', 'description': 'validation of the cyclotorsion measurement with the Heidelberg Spectralis device against tangent screen \\[degrees\\], double maddox \\[degrees\\] and fundus photographs \\[degrees\\]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trochlear Nerve Diseases']}, 'referencesModule': {'references': [{'pmid': '28765146', 'type': 'DERIVED', 'citation': 'Lengwiler F, Rappoport D, Jaggi GP, Landau K, Traber GL. Reliability of Cyclotorsion measurements using Scanning Laser Ophthalmoscopy imaging in healthy subjects: the CySLO study. Br J Ophthalmol. 2018 Apr;102(4):535-538. doi: 10.1136/bjophthalmol-2017-310396. Epub 2017 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of the influence of measuring with or without eye tracker.\n\nStudy: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg Spectralis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* best corrected visual acuity ≥ 0.8\n\nExclusion Criteria:\n\n* strabismus except for forth nerve palsy\n* previous strabismus surgery\n* monocle\n* best corrected visual acuity ≤ 0.6\n* hyperopia or myopia \\> 6dpt'}, 'identificationModule': {'nctId': 'NCT02631369', 'acronym': 'CySLO', 'briefTitle': 'Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Measuring Cyclotorsion on Scanning Laser Ophthalmoscopy (SLO)-Fundus Photographs Using the Integrated Algorithm by Heidelberg Spectralis', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2014-0404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'inter- & intrarater reliability study', 'description': 'pre-study: inter- and intrarater reliability study in 30 healthy subjects, interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device', 'interventionNames': ['Device: Heidelberg Spectralis OCT device']}, {'type': 'EXPERIMENTAL', 'label': 'cyclotorsion in forth nerve palsy', 'description': 'measurement of cyclotorsion on SLO-fundusphoto in 20 patients forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device', 'interventionNames': ['Device: Heidelberg Spectralis OCT device']}, {'type': 'EXPERIMENTAL', 'label': 'cyclotorsion in healthy subjects', 'description': 'measurement of cyclotorsion on SLO-fundusphoto in 30 healthy subjects to be compared to patients with forth nerve palsy interventions: SLO-fundus photographs using the integrated algorithm by Heidelberg Spectralis OCT (optical coherence tomography) device', 'interventionNames': ['Device: Heidelberg Spectralis OCT device']}], 'interventions': [{'name': 'Heidelberg Spectralis OCT device', 'type': 'DEVICE', 'armGroupLabels': ['cyclotorsion in forth nerve palsy', 'cyclotorsion in healthy subjects', 'inter- & intrarater reliability study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Dept of Ophthalmology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Ghislaine L Traber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Dept of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}