Uptake of Telemedicine System Trial in Rual Canton

Diabetes Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832077
• Other study ID #: ZOC-WDF-Telemedicine
• Status: Completed
• Start date: January 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: March 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: April 30, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Macular Edema
• Diabetes Mellitus
• Diabetes Retinopathy
• Macular Edema
• Retinal Diseases

Intervention

Device:
• 90 D
rural doctors exam eye fundus by 90 D
• fundus camera and grader
taking fundus pictures and graded by graders in ZOC

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, No.54, Xianlienan Road	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Orbis, The World Diabetes Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	cost-effectiveness	Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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