Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT01412905
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2011-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine Retinal Screening Utilizing a Mobile Medical Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['screening', 'diabetic retinopathy'], 'conditions': ['Diabetes', 'Retinopathy']}, 'descriptionModule': {'briefSummary': 'Objective: To test the accuracy of a referral system for diabetic eye disease conducted by a trained screener using a digital camera, a mobile medical unit and a centralized image-storing software in underserved, ethnically diverse neighborhoods in San Diego.\n\nMethods and Research Design: Retinal screening exams were offered at 8 community health centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County over 18 months. Images were captured with a special digital camera, securely transferred to a software system and read independently by a trained technician and retinal specialist. An analysis was conducted to evaluate who had severe eye disease and how accurate the reading of the technician were compared to the expert ophthalmologist readings.\n\nThe investigators would like to demonstrate that telemedicine retinal screening utilizing a mobile medical unit with a trained technician in high-risk, ethnically diverse populations can accurately detect positive and negative disease. This may be a model to increase access to retinal examination in order to meet current guidelines and can allow more efficient use of the retinal specialist to evaluate and treat disease leading to a more cost efficient method of care.', 'detailedDescription': 'Objective: To test the validity and accuracy of a grading and referral system for diabetic retinopathy conducted by a trained screener using a digital camera, a mobile medical unit and a centralized image-storing software in underserved, ethnically diverse neighborhood community health centers Methods and Research Design: Retinal screening exams using telemedicine technology were offered at 8 community health centers for 1229 individuals, ages 16-80 years with diabetes throughout San Diego County over 18 months. Images were electronically captured, transferred to EyePACs1 image software and read independently by a trained technician and retinal specialist. Statistical analysis was conducted to evaluate prevalence of disease and accuracy and validity of readings. Snellen eye test and glaucoma testing using tonometry will also be conducted.\n\nResults: Will evaluate demographics that include age, gender, ethnicity, duration of diabetes, type of diabetes and need for dilation. Severity of disease will be captured. Statistical analysis will be conducted for technician accuracy of grading the readings.\n\nConclusions: To demonstrate that telemedicine retinal screening utilizing a mobile medical unit with a trained technician in high-risk, ethnically diverse populations can accurately detect positive and negative screens. This may be a model to increase access to retinal examination in order to meet ADA and HEDIS guidelines and can allow more efficient use of the retinal specialist to evaluate and treat disease leading to a more cost efficient method of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and Women, ages 16-80 with type 1 and type 2 diabetes mellitus identified from 8 community health centers in San Diego County.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 16-80 years;\n* diagnoses of type 1 or 2 diabetes;\n* enrolled in one of the participating clinics or has a personal primary care provider;\n* no or minimal insurance and is a San Diego County resident.\n\nExclusion criteria:\n\n* high intra-ocular pressure \\> 21 mmHg and \\< 4 mm of pupil dilation\n* known allergy to latex .'}, 'identificationModule': {'nctId': 'NCT01412905', 'briefTitle': 'Telemedicine Retinal Screening Utilizing a Mobile Medical Unit', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Whittier Diabetes Institute'}, 'officialTitle': 'Telemedicine Retinal Screening Utilizing a Mobile Medical Unit With a Trained Technician Accurately Detects Disease in High Risk Ethnically Diverse Populations: Results of a Project Dulce™ Retinal Screening Study', 'orgStudyIdInfo': {'id': 'SWDI-Retinal'}}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Whittier Diabetes Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Athena Philis-Tsimikas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Whittier Diabetes Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Whittier Diabetes Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonseca Family Foundation', 'class': 'UNKNOWN'}, {'name': 'Blue Shield Foundation', 'class': 'UNKNOWN'}, {'name': 'NCRR 1U54RR025204-01-01', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Corp VP', 'investigatorFullName': 'Athena Philis-Tsimikas', 'investigatorAffiliation': 'Scripps Whittier Diabetes Institute'}}}}