Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT07218835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compact Auto-Aligning Multi-Modal Eye Imaging to Diagnose Traumatic Eye Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-10-16', 'studyFirstSubmitQcDate': '2025-10-16', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who found the eye imaging device easy to use', 'timeFrame': 'up to 2 years'}, {'measure': 'Number of participants who found the eye imaging device mobile', 'timeFrame': 'up to 2 years'}, {'measure': 'Number of participants who found the eye imaging device reliable', 'timeFrame': 'up to 2 years'}, {'measure': 'Image quality as measured by the number of eye condition diagnoses that match official diagnoses', 'timeFrame': 'up to 2 years', 'description': 'Diagnoses made from the eye imaging device will be compared to the official diagnoses the patients received from a full eye exam in the clinic or emergency department.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ocular Pathologies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an investigational eye imaging device by taking pictures of participants eyes with a single image capture that takes only seconds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Duke Eye Center patients will be drawn from the Eye Center clinics and from Duke Emergency Department consulted by ophthalmologist in the Emergency Department.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular complaints potentially indicating anterior segment pathology (e.g., corneal abrasions, corneal edema, corneal scars)\n* Ocular complaints potentially indicating posterior segment pathology (e.g., macular edema, neovascular, macular degeneration)\n\nExclusion Criteria:\n\n* Participant is unable to be imaged for any reason'}, 'identificationModule': {'nctId': 'NCT07218835', 'briefTitle': 'Compact Auto-Aligning Multi-Modal Eye Imaging to Diagnose Traumatic Eye Injury', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Compact Auto-Aligning Multi -Modal Eye Imaging', 'orgStudyIdInfo': {'id': 'Pro00117676'}, 'secondaryIdInfos': [{'id': 'HT9425-24-1-0870', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tri-Modality, auto-aligning ocular imaging with compact handheld instrument', 'description': "Color photography, anterior and posterior segment OCT images with the investigational eye imaging system will be taken of consented participant's eyes presenting within Duke Eye Center and Duke University emergency room", 'interventionNames': ['Device: Auto-aligning Ocular imaging instrument']}], 'interventions': [{'name': 'Auto-aligning Ocular imaging instrument', 'type': 'DEVICE', 'description': 'Develop a tri-modality, auto-aligning ocular imaging instrument incorporating gross color photography, anterior and posterior segment OCT in a compact, handheld form factor.', 'armGroupLabels': ['Tri-Modality, auto-aligning ocular imaging with compact handheld instrument']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Teresa Hawks', 'role': 'CONTACT', 'email': 'teresa.hawks@duke.edu', 'phone': '919-681-1569'}], 'overallOfficials': [{'name': 'Anthony Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}