Uptake of Telemedicine System Trial in Rual Canton

N/ACompletedNCT01832077

Sun Yat-sen University5,000 enrolled

Overview

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

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

5,000

Conditions

Diabetes Retinopathy Diabetes Macular Edema

Interventions

90 DDEVICE

rural doctors exam eye fundus by 90 D

fundus camera and graderDEVICE

taking fundus pictures and graded by graders in ZOC

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center, No.54, Xianlienan Road

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 2 years

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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