Uptake of Telemedicine System Trial in Rual Canton

Overview

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

Full Title of Study: “The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 1, 2017

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

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

Arms, Groups and Cohorts

  • rural doctor
    • examine patient’s fundus by 90D fundus pre-set lens
  • grader
    • grade fundus pictures in ZOC

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • cost-effectiveness
    • Time Frame: 2 years
    • Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)

Secondary Measures

  • 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)
  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Orbis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Congdon Nathan, vice director,Blindness Prevention and Treatment Department – Sun Yat-sen University
  • Overall Official(s)
    • Nathan Congdong, MD,MPH, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University

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