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Telemedicine Retinal Screening Utilizing a Mobile Medical Unit

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01412905
Enrollment
1229
Registered
2011-08-09
Start date
2007-02-28
Completion date
2009-08-31
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Retinopathy

Keywords

screening, diabetic retinopathy

Brief summary

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. Methods 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. The 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.

Detailed description

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. Results: 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. Conclusions: 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.

Interventions

None listed

Sponsors

Fonseca Family Foundation
CollaboratorUNKNOWN
Blue Shield Foundation
CollaboratorUNKNOWN
NCRR 1U54RR025204-01-01
CollaboratorUNKNOWN
Scripps Whittier Diabetes Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age 16-80 years; * diagnoses of type 1 or 2 diabetes; * enrolled in one of the participating clinics or has a personal primary care provider; * no or minimal insurance and is a San Diego County resident.

Exclusion criteria

* high intra-ocular pressure \> 21 mmHg and \< 4 mm of pupil dilation * known allergy to latex .

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026