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Telemedicine Retinal Screening Utilizing a Mobile Medical Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412905
First Posted: August 9, 2011
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fonseca Family Foundation
Blue Shield Foundation
NCRR 1U54RR025204-01-01
Information provided by:
Scripps Whittier Diabetes Institute
  Purpose

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.


Condition
Diabetes Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Scripps Whittier Diabetes Institute:

Enrollment: 1229
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and Women, ages 16-80 with type 1 and type 2 diabetes mellitus identified from 8 community health centers in San Diego County.
Criteria

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 .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412905


Locations
United States, California
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
Fonseca Family Foundation
Blue Shield Foundation
NCRR 1U54RR025204-01-01
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
  More Information

Responsible Party: Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT01412905     History of Changes
Other Study ID Numbers: SWDI-Retinal
First Submitted: August 8, 2011
First Posted: August 9, 2011
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Scripps Whittier Diabetes Institute:
screening
diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases