Uptake of Telemedicine System Trial in Rual Canton

Completed

• Conditions: Diabetes Retinopathy; Diabetes Macular Edema
• Interventions: Device: 90 D; Device: fundus camera and grader

• Registration Number: NCT01832077
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-15
• Study Start: 2015-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rural doctor	90 D	examine patient's fundus by 90D fundus pre-set lens
grader	fundus camera and grader	grade fundus pictures in ZOC

Primary Outcome Measures

Name	Time	Method
cost-effectiveness	2 years	Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)
Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, No.54, Xianlienan Road; 🇨🇳 Guangzhou, Guangdong, China