Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT03419351
Status:
UNKNOWN
Last Update Posted:
2018-02-01
First Post:
2017-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D016353', 'term': 'Self-Examination'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refractive Error', 'timeFrame': '6 month', 'description': 'Comparison of refractive error measurements between methods'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '6 month', 'description': 'Visual acuity of persons using based on different methods.'}, {'measure': 'Personal evaluation of measuring accuracy (Questionnaire)', 'timeFrame': '6 month', 'description': 'Would persons be willing to order glasses by using only self-test-results?'}, {'measure': 'Time consumption', 'timeFrame': '6 month', 'description': 'Comparison of needed time to reach self-test refraction error results and conservative-test results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Errors', 'Self-Examination']}, 'descriptionModule': {'briefSummary': 'Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons.\n\nThe daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure.\n\nThe study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* existing refractive error\n* using glasses or contac lenses\n\nExclusion Criteria:\n\n* opacities (visus limitating) of cornea, lens or vitreous\n* known ocular pathologies except refractive error\n* epilepsia\n* irregular corneal topography'}, 'identificationModule': {'nctId': 'NCT03419351', 'briefTitle': 'Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods', 'orgStudyIdInfo': {'id': 'smart-glass'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Main group', 'description': 'Main study group including all individuals that underwent the study procedures', 'interventionNames': ['Diagnostic Test: Smartphone', 'Diagnostic Test: Autorefractor', 'Diagnostic Test: Individual']}], 'interventions': [{'name': 'Smartphone', 'type': 'DIAGNOSTIC_TEST', 'description': 'Smartphone based measurement of refractive error and visual acuity testing using these measurements.', 'armGroupLabels': ['Main group']}, {'name': 'Autorefractor', 'type': 'DIAGNOSTIC_TEST', 'description': 'Autorefractor based measurement of refractive error and visual acuity testing using these measurements.', 'armGroupLabels': ['Main group']}, {'name': 'Individual', 'type': 'DIAGNOSTIC_TEST', 'description': 'Individual, human measurement of refractive error and visual acuity testing using these measurements.', 'armGroupLabels': ['Main group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin A Leitritz, M.D.', 'role': 'CONTACT', 'email': 'martin.leitritz@med.uni-tuebingen.de', 'phone': '+49 (0) 7071-29-88088'}, {'name': 'Martin A Leitritz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sebastian Mueller, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Markus Schulze-Schwering, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Eye Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Martin Leitritz', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}