Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 6:45 PM
Study NCT ID:
NCT04299659
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Four Methods for Entering the Gap Position of Landolt Cs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'validity', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Proportion of correct gap position entries in relation to the total number of LC presentations by the four different entry methods'}], 'secondaryOutcomes': [{'measure': 'retest reliability', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Comparison of the correct gap position entry between first and second test run by the four different entry methods'}, {'measure': 'Examination duration', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Comparison of the examination duration of the the four different entry methods and by the first and second run'}, {'measure': 'Subjects´ satisfaction', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Subjects´ evaluation (using a questionnaire) for the four different entry methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychophysics', 'visual acuity', 'response', 'response entry', 'validity', 'retest reliability', 'reproducibility', 'evaluation', 'optotype', 'Landolt C'], 'conditions': ['Quality Control', 'Validation Study']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate and compare the validity of four different input methods for Landolt Cs, i.e. the proportion of correct gap positions in relation to the total number of performances. The four input methods are a numeric keypad, an eight-positions rocker switch, a remote control and voice feedback.', 'detailedDescription': 'The measurement of visual acuity is the most frequent and one of the most important ophthalmological functional investigations. Therefore, it is particularly important to find a measuring procedure with as little input errors as possible.\n\nThe 8-position Landolt C (LC) is the internationally accepted, well-standardised optotype for the determination of visual acuity.\n\nUsually, the subjects informs the examiner verbally about the perceived position of each LC. According to the current literature, about 20 to 30 % of the population suffers from a right/left weakness. Furthermore, language barriers are an additional considerable hurdle.\n\nTherefore, it is important to find an input method for the LC gap positions with minimal entry mistakes. In oder to avoid the thresholding procedure and its inherent difficulties, highly supra-threshold (10 times above the previously determined individual central visual acuity threshold) 8-position LCs are presented.\n\nThe study compares four input methods for entering of the Landolt C gap positions: a modified numeric keypad, an 8-position rocker switch, a modified TV remote control and voice/verbal feedback.\n\nEach subject will perform all four input methods, with 2 test runs of 16 Landolt C presentations, each. A forced-choice method will be applied, i.e. the test is not continued until the test person has responded ot each single presentation. Regardless of whether the entry was correct or incorrect, the next Landolt C is displayed.\n\nThe optotypes are presented using modified version of the Freiburg Visual Acuity and Contrast Test (FrACT), which allows to present the 8-position Landolt Cs in a standardized way on a video display unit (VDU).\n\nThe sequence of the input methods is randomized. This study is carried out in a "within-subject design", i.e. all test persons go through all test conditions and serve as their own controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, young subjects recruited for the students and or co-workers of the Aalen University of Applied Sciences', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Informed consent\n* (Distance) visual acuity with best correction: ≥ 0.8\n* (Distant) ametropia: ≤+8.0 Diopters (spherical equivalent)\n* Anisometropia ≤ 3 dpt\n* Astigmatism ≤ 2.5 dpt\n\nExclusion Criteria:\n\n* Prolonged reaction time caused by drugs (medications)/ drugs/alcohol\n* Movement disorders (of hands) such as Parkinson\'s disease\n* Indication of amblyopia (strabismus surgery, occlusion therapy etc.)\n* Eye movement disorders/double vision\n* Defective stereo vision (according to LANG \\[I\\] stereo test)\n* Presence of a relative afferent pupil defect ("swinging flashlight test)\n* Any hint of visual pathway lesion or other chronic or progressive eye disease'}, 'identificationModule': {'nctId': 'NCT04299659', 'acronym': 'LC_Entry', 'briefTitle': 'Comparison of Four Methods for Entering the Gap Position of Landolt Cs', 'organization': {'class': 'OTHER', 'fullName': 'Aalen University'}, 'officialTitle': 'Comparison of Four Methods for Entering the Gap Position of Landolt Cs With Respect to Validity, Retest Reliability, Examination Duration and Test Subject Satisfaction', 'orgStudyIdInfo': {'id': 'LC Entry_2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Landolt C entry method', 'type': 'DIAGNOSTIC_TEST', 'description': 'Four different methods for entering the Landolt C gap position are compared'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73430', 'city': 'Aalen', 'state': 'Deutschland', 'country': 'Germany', 'facility': 'Ulrich SCHIEFER', 'geoPoint': {'lat': 48.83777, 'lon': 10.0933}}], 'overallOfficials': [{'name': 'Ulrich Schiefer, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': '+49 7361 576-4605'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}