Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-08 @ 1:06 AM
Study NCT ID:
NCT04249505
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refractive Accuracy of "2WIN" and Portable Autorefractors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refractive Accuracy', 'timeFrame': '1 day', 'description': 'spherical equivalent'}, {'measure': 'Refractive Accuracy', 'timeFrame': '1 day', 'description': 'Vector transform J0 and J45 astigmatism'}, {'measure': 'Refractive Accuracy', 'timeFrame': '1 day', 'description': 'Spectacle comparison score (Percent similarity combined sphere-cylinder)'}], 'secondaryOutcomes': [{'measure': 'Impact of age', 'timeFrame': '1 day', 'description': "Spectacle similarity score striated by age relative to patient's ability to accommodate"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['photoscreening', 'photo refraction', 'auto refraction', 'spectacle dispensing'], 'conditions': ['Refractive Error - Myopia Axial', 'Astigmatism', 'Accomodation', 'Visual Impairment', 'Hyperopia of Both Eyes']}, 'referencesModule': {'references': [{'pmid': '31077668', 'type': 'BACKGROUND', 'citation': 'Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.', 'detailedDescription': 'A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.\n\nAs a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.\n\nThe ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.\n\nThis algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children and adults attending pediatric ophthalmology and adult strabismus clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included\n\nExclusion Criteria:\n\n* Intraocular lens in place'}, 'identificationModule': {'nctId': 'NCT04249505', 'briefTitle': 'Refractive Accuracy of "2WIN" and Portable Autorefractors', 'organization': {'class': 'OTHER', 'fullName': 'Alaska Blind Child Discovery'}, 'officialTitle': 'The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor', 'orgStudyIdInfo': {'id': 'ABCD RefAcc'}}, 'armsInterventionsModule': {'interventions': [{'name': '"2WIN" Photoscreener', 'type': 'DEVICE', 'description': 'non-cycloplegia refraction by Adaptica "2WIN"'}, {'name': '"Plusoptix A12"', 'type': 'DEVICE', 'description': 'non-cycloplegic refraction by "Plusoptix A12" photoscreener'}, {'name': '"Retinomax"', 'type': 'DEVICE', 'description': 'non-cycloplegic refraction by "Retinomax K+" auto refractor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Children's EYE & Strabismus", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}], 'overallOfficials': [{'name': 'Bob Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coordinator Alaska Blind Child Discovery'}]}, 'ipdSharingStatementModule': {'url': 'http://www.abcd-vision.org/references/index.html', 'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'after study completed', 'ipdSharing': 'YES', 'description': 'de-identified database shared on www.ABCD-Vision.org Website.', 'accessCriteria': 'open'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaska Blind Child Discovery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}