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Telemedicine Retinal Screening Utilizing a Mobile Medical Unit

NCT ID: NCT01412905

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Diabetes Retinopathy

Keywords

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screening diabetic retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 .
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonseca Family Foundation

UNKNOWN

Sponsor Role collaborator

Blue Shield Foundation

UNKNOWN

Sponsor Role collaborator

NCRR 1U54RR025204-01-01

UNKNOWN

Sponsor Role collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Athena Philis-Tsimikas

Corp VP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Locations

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Scripps Whittier Diabetes Institute

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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SWDI-Retinal

Identifier Type: -

Identifier Source: org_study_id