Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-06 @ 11:24 AM
Study NCT ID:
NCT06431295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements', 'timeFrame': 'Baseline', 'description': 'Number of subjects to have agreement between the visual acuity digital device and the clinical assessment'}], 'secondaryOutcomes': [{'measure': 'Voice samples', 'timeFrame': 'Baseline', 'description': 'Total number of voice samples collected of spoken letters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18 years) who come to Ophthalmology Clinic.\n* Willing and able to provide consent.\n\nExclusion Criteria:\n\n* Individuals \\< 18 years of age.\n* Unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT06431295', 'briefTitle': 'Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Human Performance Evaluation of a Digital Visual Acuity Device: Visual Acuity-001', 'orgStudyIdInfo': {'id': '23-007148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Visual Acuity Test', 'description': 'Subjects for an ophthalmological examination that includes a visual acuity examination at Mayo Clinic in Florida have a digital visual acuity test conducted with the FaceScan device.', 'interventionNames': ['Device: FaceScan']}], 'interventions': [{'name': 'FaceScan', 'type': 'DEVICE', 'description': 'Digital visual acuity device built for iOS ("iPhone") that conducts an assessment of visual acuity using a combination of integrated light detection and ranging (LiDAR) and voice processing.', 'armGroupLabels': ['Digital Visual Acuity Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Antonio Forte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio J. Forte', 'investigatorAffiliation': 'Mayo Clinic'}}}}