Telemedicine Retinal Screening Utilizing a Mobile Medical Unit

NCT01412905 | Completed

• 1 other identifier: SWDI-Retinal
• Study Type: observational
• Target: 1,229
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Retinopathy

Keywords

screening; diabetic retinopathy

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• Fonseca Family Foundation: collaborator
• Blue Shield Foundation: collaborator
• NCRR 1U54RR025204-01-01: collaborator

Study Sites (1)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Athena Philis-Tsimikas, MD

  Scripps Whittier Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Corp VP

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: February 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

US (1)