Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT06173232
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Retinal Fundus Imaging Camera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-11', 'releaseDate': '2025-03-24'}], 'estimatedResultsFirstSubmitDate': '2025-03-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Objective', 'timeFrame': '1 Day', 'description': 'Agreement of AI device probability scores obtained from fundus cameras'}, {'measure': 'Exploratory Endpoint', 'timeFrame': '1 Day', 'description': 'Agreement of AI device results (mtmDR(+), mtmDR(-), "Exam Quality Insufficient" obtained from fundus cameras'}], 'primaryOutcomes': [{'measure': 'Primary Objective', 'timeFrame': '1 Day', 'description': 'Agreement of AI device results (mtmDR(+), mtmDR(-)) obtained from fundus cameras'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.', 'detailedDescription': 'The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy (ETDRS level 35 and higher) with or without macular edema. Study subjects will sign the informed consent form, and data collection will involve being imaged by cameras.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A minimum of 80 eligible subjects, these subjects will be categorized as ETDRS ≥ 35 with or without DME and subjects with ETDRS 20 or less and no DME', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 22 years of age or older.\n* Documented diagnosis of diabetes mellitus, as per any of the following: Having met the criteria established by the World Health Organization (WHO) and/or the American Diabetes Association (ADA), Hemoglobin A1c (HbA1c) ≥ 6.5%, Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75g anhydrous glucose dose dissolved in water, Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Diagnosis from a retinal specialist of ETDRS level of 35 or higher with or without DME or diagnosis from a retinal specialist of ETDRS level 20 or lower and no DME.\n* Standard Corrected Visual Acuity of at least 20/40 or better in both eyes.\n\nExclusion Criteria:\n\n* Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).\n* Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation).\n* Pregnancy\n* Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops.\n* Any condition that is contraindicated for the use of study devices in the opinion of the investigator.\n* Contraindication for imaging by devices used in the study due to any of the following:\n* Subject is hypersensitive to light\n* Subject recently underwent photodynamic therapy (PDT)\n* Subject is taking medication that causes photosensitivity'}, 'identificationModule': {'nctId': 'NCT06173232', 'briefTitle': 'Assessment of Retinal Fundus Imaging Camera', 'organization': {'class': 'INDUSTRY', 'fullName': 'Digital Diagnostics, Inc.'}, 'officialTitle': 'Assessment of Retinal Fundus Imaging Camera', 'orgStudyIdInfo': {'id': 'PRO-CLN-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Subjects with ETDRS ≥ 35 with or without DME', 'interventionNames': ['Device: Camera Imaging']}, {'label': 'Group 2', 'description': 'Subjects with ETDRS 20 or less and no DME', 'interventionNames': ['Device: Camera Imaging']}], 'interventions': [{'name': 'Camera Imaging', 'type': 'DEVICE', 'description': 'Camera Imaging', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45202', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Savannah Hollingsworth', 'role': 'CONTACT'}, {'name': 'Christopher Devine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Midwest Eye Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Breanne MacMillan, MS', 'role': 'CONTACT', 'email': 'macmillan@digitaldiagnostics.com', 'phone': '815-931-1354'}], 'overallOfficials': [{'name': 'Audrey Singh, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Digital Diagnostics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Digital Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-24', 'type': 'RELEASE'}, {'date': '2025-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Digital Diagnostics, Inc.'}}}}