Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-04 @ 9:55 PM
Study NCT ID:
NCT04820218
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects who had previously tested with an EyeQue ophthalmic refraction device and ordered try-on glasses will be asked to measure their visual acuity with and without their try-on glasses.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity with and without try-on glasses', 'timeFrame': 'Visit 1: Day 0', 'description': 'Visual Acuity with and without try-on glasses'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Impairment', 'Myopia', 'Hyperopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.', 'detailedDescription': 'This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or Female\n2. Ages 30+\n3. Had purchased an EyeQue refraction device.\n4. Obtained EGN's from the EyeQue refraction device.\n5. Ordered Try-On glasses based on EyeQue EyeGlass Numbers.\n6. Allow use for this study the VisionCheck refraction and try-on glasses measurements, taken prior to study participation.\n\nSubject Exclusion Criteria, Subjects that by self-report:\n\n1. Do not have a command of the English language.\n2. Lack the ability to follow instructions.\n3. Lack binocular vision.\n4. Are Color-blind."}, 'identificationModule': {'nctId': 'NCT04820218', 'briefTitle': 'At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeQue Corp.'}, 'officialTitle': 'An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults', 'orgStudyIdInfo': {'id': 'EYEQUE - 008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Without Try-on glasses', 'description': 'Subjects will be asked to measure their visual acuity without their try-on glasses', 'interventionNames': ['Device: With Try-on glasses']}], 'interventions': [{'name': 'With Try-on glasses', 'type': 'DEVICE', 'description': 'Subjects will be asked to measure their visual acuity with their try-on glasses', 'armGroupLabels': ['Without Try-on glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94560', 'city': 'Newark', 'state': 'California', 'country': 'United States', 'facility': 'EyeQue', 'geoPoint': {'lat': 37.52966, 'lon': -122.04024}}], 'overallOfficials': [{'name': 'Noam Sapiens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EyeQue Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeQue Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}