Uptake of Telemedicine System Trial in Rual Canton

March 18, 2021 updated by: Congdon Nathan, Sun Yat-sen University

The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton

To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Telemedicine system mainly contains a comprehensive eye examination electric-records (E-record), which can transfer the fundus pictures from rural hospitals to professional Graders (golden standard for a diagnose of Diabetes Retinopathy (DR) and Diabetes Macular Edema(DME)). In Zhongshan Ophthalmic Center (ZOC). By this system, the investigators can evaluate the capacity of rural eye doctors about the diagnosis of DR/DME, and give proper suggestions for the treatment and revisit plan.

Study Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, No.54, Xianlienan Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients

Description

Inclusion Criteria:

  • age > 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients

Exclusion Criteria:

  • unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rural doctor
examine patient's fundus by 90D fundus pre-set lens
Device: 90 D
rural doctors exam eye fundus by 90 D
grader
grade fundus pictures in ZOC
Device: fundus camera and grader
taking fundus pictures and graded by graders in ZOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading
Time Frame: 2 years after the telemedicine begin to use
To compare the sensitivity, specificity and positive and negative predictive value for a diagnosis of DR/DME , a diagnosis of DR/DME requiring treatment, of trained rural doctors and an automated grading system, as compared to trained graders using photographs (the gold standard)
2 years after the telemedicine begin to use
cost-effectiveness
Time Frame: 2 years
Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of comprehensive eye examination taken by rural doctors
Time Frame: 2 years
Frequency with which trained rural doctors continue to implement suggested examinations (IOP, gonioscopy, pupil exam, dilated examination)
2 years
comprehensive eye examination rate among patients in rural hospitals
Time Frame: 2 years
Frequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors.
2 years
the usage rate of Electric-Record
Time Frame: 2 years
to evaluate the usage rate of E-record by rural doctors when they see patients in the eye clinic, and its influencing factors.
2 years
Cost-effectiveness of van
Time Frame: 2 years
compare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Orbis
The World Diabetes Foundation

Investigators

  • Principal Investigator: Nathan Congdong, MD,MPH, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOC-WDF-Telemedicine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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