Zhongshan Ophthalmic Center, No.54, Xianlienan Road
Guangzhou, Guangdong, 510060, China
Completed
NCT Number: NCT01832077
Uptake of Telemedicine System Trial in Rual Canton
To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.
Completed
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Notify MeKey information
Conditions
Age range
40 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
90 D
Devicerural doctors exam eye fundus by 90 D
fundus camera and grader
Devicetaking fundus pictures and graded by graders in ZOC
Primary outcomes
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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)
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cost-effectiveness
Time frame: 2 years
Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)
Secondary outcomes
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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)
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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.
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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.
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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
Sponsors and collaborators
Lead sponsor
Sun Yat-sen University
Other
Collaborators
- Orbis
- The World Diabetes Foundation
Registry information
Official study title
The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Apr 15, 2013
- Registry last updated
- Mar 19, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.