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Uptake of Telemedicine System Trial in Rual Canton

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01832077
Enrollment
5000
Registered
2013-04-15
Start date
2015-01-31
Completion date
2017-04-30
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Macular Edema, Diabetes Retinopathy

Keywords

sensibility, specificity, positive predictive value, negative predictive value, Cost-effectiveness

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.

Interventions

DEVICE90 D

rural doctors exam eye fundus by 90 D

DEVICEfundus camera and grader

taking fundus pictures and graded by graders in ZOC

Sponsors

Orbis
CollaboratorOTHER
The World Diabetes Foundation
CollaboratorOTHER
Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading2 years after the telemedicine begin to useTo 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)
cost-effectiveness2 yearsCost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)

Secondary

MeasureTime frameDescription
Frequency of comprehensive eye examination taken by rural doctors2 yearsFrequency with which trained rural doctors continue to implement suggested examinations (IOP, gonioscopy, pupil exam, dilated examination)
comprehensive eye examination rate among patients in rural hospitals2 yearsFrequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors.
the usage rate of Electric-Record2 yearsto 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 van2 yearscompare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026