Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-28 @ 1:26 PM
Study NCT ID:
NCT04642495
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction intervals of Snellen acuity for the SW', 'timeFrame': '12 months', 'description': 'Prediction intervals of Snellen acuity for the SW compared to Landolt C and E symbols'}], 'secondaryOutcomes': [{'measure': 'Prediction intervals of Snellen acuity for Landolt C compared to E symbols', 'timeFrame': '12 months', 'description': 'Prediction intervals of Snellen acuity for Landolt C compared to E symbols'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'referencesModule': {'references': [{'pmid': '31526857', 'type': 'BACKGROUND', 'citation': 'Schwob N, Palmowski-Wolfe A. Objective measurement of visual acuity by optokinetic nystagmus suppression in children and adult patients. J AAPOS. 2019 Oct;23(5):272.e1-272.e6. doi: 10.1016/j.jaapos.2019.05.016. Epub 2019 Sep 14.'}, {'pmid': '32330979', 'type': 'BACKGROUND', 'citation': 'Schwob N, Palmowski-Wolfe A. Establishing an Objective Measurement of Visual Acuity with a Computerised Optokinetic Nystagmus Suppression Test. Klin Monbl Augenheilkd. 2020 Apr;237(4):502-505. doi: 10.1055/a-1119-6123. Epub 2020 Apr 24.'}, {'pmid': '33853189', 'type': 'RESULT', 'citation': 'Luethy ML, Schotzau A, Palmowski-Wolfe A. Establishing Prediction Intervals for the SpeedWheel Acuity Test in Adults and Children. Klin Monbl Augenheilkd. 2021 Apr;238(4):488-492. doi: 10.1055/a-1403-2218. Epub 2021 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.', 'detailedDescription': 'In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers aged 4 and above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able and willing to perform the test\n\nExclusion Criteria:\n\n* under 4 years of age\n* unable or unwilling'}, 'identificationModule': {'nctId': 'NCT04642495', 'acronym': 'Speedwheel', 'briefTitle': 'Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Clinical Application of Objective Visual Acuity Measurement Using Suppression Method to Inhibit Optokinetic Nystagmus (OKN).', 'orgStudyIdInfo': {'id': '2016-02078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Human subjects aged 4 and above', 'description': 'Human volunteers aged 4 and above.', 'interventionNames': ['Diagnostic Test: Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols']}], 'interventions': [{'name': 'Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols', 'type': 'DIAGNOSTIC_TEST', 'description': 'Establish prediction intervals for acuity tests', 'armGroupLabels': ['Human subjects aged 4 and above']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Basel, University Eye Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Anja M Palmowski-Wolfe, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Basel, University Eye Hospital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The results are to be shared in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.', 'investigatorFullName': 'Anja Palmowski-Wolfe', 'investigatorAffiliation': 'University of Basel'}}}}