This trial is active, not recruiting.

Conditions diabetes retinopathy, diabetes macular edema
Treatments 90 d, fundus camera and grader
Sponsor Sun Yat-sen University
Collaborator Orbis
Start date April 2013
End date May 2015
Trial size 5000 participants
Trial identifier NCT01832077, ZOC-WDF-Telemedicine


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
examine patient's fundus by 90D fundus pre-set lens
90 d
rural doctors exam eye fundus by 90 D
grade fundus pictures in ZOC
fundus camera and grader
taking fundus pictures and graded by graders in ZOC

Primary Outcomes

Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading
time frame: 2 years after the telemedicine begin to use
time frame: 2 years

Secondary Outcomes

Frequency of comprehensive eye examination taken by rural doctors
time frame: 2 years
comprehensive eye examination rate among patients in rural hospitals
time frame: 2 years
the usage rate of Electric-Record
time frame: 2 years
Cost-effectiveness of van
time frame: 2 years

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

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

Additional Information

Official title The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
Principal investigator Nathan Congdong, MD,MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.