Uptake of Telemedicine System Trial in Rual Canton

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

Detailed Description
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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.

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

Conditions
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Diabetes Retinopathy, Diabetes Macular Edema

Intervention / Treatment
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* Device: 90 D
* Device: fundus camera and grader


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading | 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 | 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 | 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 | Frequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors. | 2 years | 
| the usage rate of Electric-Record | 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 | compare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensibility, specificity, positive predictive value, negative predictive value, Cost-effectiveness