Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03912961
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease', 'timeFrame': '3 months', 'description': 'To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with gradable images taken by the hand held camera', 'timeFrame': '3 months', 'description': 'Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts'}, {'measure': 'Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists', 'timeFrame': '3 months', 'description': 'To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;\n2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;\n3. Subjects who have been diagnosed with Type I or Type II diabetes mellitus.\n\nExclusion Criteria:\n\n1. Subjects unable to tolerate ophthalmic imaging;\n2. Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.\n3. Subject blind in one eye due to any cause\n4. Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation."}, 'identificationModule': {'nctId': 'NCT03912961', 'acronym': 'SC-DRAI', 'briefTitle': 'The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study', 'organization': {'class': 'OTHER', 'fullName': 'Retina Global'}, 'officialTitle': "Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera", 'orgStudyIdInfo': {'id': '2019-BOL-SC-DRAI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Picture of the retina with a handheld retinal camera', 'type': 'OTHER', 'description': 'Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Cruz de la Sierra', 'country': 'Bolivia', 'facility': 'Centro Medico Kolping', 'geoPoint': {'lat': -17.78629, 'lon': -63.18117}}, {'city': 'Santa Cruz de la Sierra', 'country': 'Bolivia', 'facility': 'Clinica Incor', 'geoPoint': {'lat': -17.78629, 'lon': -63.18117}}, {'city': 'Santa Cruz de la Sierra', 'country': 'Bolivia', 'facility': 'Hospital Universitario Japones', 'geoPoint': {'lat': -17.78629, 'lon': -63.18117}}], 'overallOfficials': [{'name': 'Rajat Agrawal, MD MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Retina Global'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Global', 'class': 'OTHER'}, 'collaborators': [{'name': 'VisionQuest Biomedical LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}