Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-29 @ 10:47 PM
Study NCT ID:
NCT01995435
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refraction Determination Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D001248', 'term': 'Asthenopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}, {'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'patient satisfaction from telerefraction', 'timeFrame': 'an average of 1 year'}], 'primaryOutcomes': [{'measure': 'refraction in diopters over telemedicine compared standard phoropter refraction', 'timeFrame': 'an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'telemedicine refraction results beyond dioptric readings', 'timeFrame': 'an average of 1 year', 'description': 'to see if there are other uses for telemedicine refraction results'}]}, 'conditionsModule': {'conditions': ['Myopia,', 'Hyperopia,', 'Astigmatism,', 'Presbyopia,', 'Eye Strain,']}, 'descriptionModule': {'briefSummary': 'Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old\n* healthy eyes\n\nExclusion Criteria:\n\n* mid level ocular diseases (glaucoma, hypertension, retinal issues)\n* psychiatric disorders\n* brain tumor or history of\n* under 18, or over 40 years old'}, 'identificationModule': {'nctId': 'NCT01995435', 'briefTitle': 'Refraction Determination Analysis', 'organization': {'class': 'INDIV', 'fullName': 'Lee, Steven, M.D.'}, 'orgStudyIdInfo': {'id': 'SPL-321-REF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine refraction before traditional refraction', 'description': 'We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method.', 'interventionNames': ['Device: Telemedicine refraction', 'Device: Traditional refraction']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional refraction before telemedicine refraction', 'description': 'We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method.', 'interventionNames': ['Device: Telemedicine refraction', 'Device: Traditional refraction']}], 'interventions': [{'name': 'Telemedicine refraction', 'type': 'DEVICE', 'otherNames': ['Glasses,', 'Contact lenses,', 'Refractive surgery,'], 'armGroupLabels': ['Telemedicine refraction before traditional refraction', 'Traditional refraction before telemedicine refraction']}, {'name': 'Traditional refraction', 'type': 'DEVICE', 'armGroupLabels': ['Telemedicine refraction before traditional refraction', 'Traditional refraction before telemedicine refraction']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lee, Steven, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Coad Dow, MD', 'investigatorAffiliation': 'Chippewa Valley Eye Clinic'}}}}