Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT03358550
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2017-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Night Myopia and Dark Focus of Accommodation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Sequence of tests was randomized. It is no multi-arm study.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-11-26', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shift of accommodation in scotopic luminance (Dark focus)', 'timeFrame': 'Baseline only', 'description': 'Accommodative shift in scotopic luminance compared to photopic luminance for empty field (dark focus of accommodation)'}], 'secondaryOutcomes': [{'measure': 'Difference of accommodation for 2 m target', 'timeFrame': 'Baseline only', 'description': 'Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 2 m'}, {'measure': 'Difference of accommodation for 1 m target', 'timeFrame': 'Baseline only', 'description': 'Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 1 m'}, {'measure': 'Difference of accommodation for 0.5 m target', 'timeFrame': 'Baseline only', 'description': 'Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 0.5 m'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['accommodation', 'dark focus', 'night myopia'], 'conditions': ['Dark Focus of Accommodation']}, 'descriptionModule': {'briefSummary': 'Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.', 'detailedDescription': 'Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO). Full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study. Accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. At scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation. After adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 - 44\n* visual acuity at least 0.8 (5/6)\n\nExclusion Criteria:\n\n* medication with an impact on the visual system\n* visual disease or disease with an impact on the visual system\n* pregnancy or other hormonal variances\n* drug usage\n* overfatigue at the period of investigation\n* mental handicap'}, 'identificationModule': {'nctId': 'NCT03358550', 'briefTitle': 'Night Myopia and Dark Focus of Accommodation', 'organization': {'class': 'OTHER', 'fullName': 'University of Applied Sciences Jena'}, 'officialTitle': 'Influence of an Imaginary Target on the State of Accommodation Under Scotopic Conditions', 'orgStudyIdInfo': {'id': 'UASJena'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accommodation in scotopic luminance', 'interventionNames': ['Diagnostic Test: Accommodation Measurement']}], 'interventions': [{'name': 'Accommodation Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Accommodation was measured for different distances and light conditions.', 'armGroupLabels': ['Accommodation in scotopic luminance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07745', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'University of Applied Sciences', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Philipp Hessler, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Applied Sciences Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Philipp Hessler', 'investigatorAffiliation': 'University of Applied Sciences Jena'}}}}