NCT01832077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

April 11, 2013

Last Update Submit

March 18, 2021

Conditions

Keywords

sensibilityspecificitypositive predictive valuenegative predictive valueCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • 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

  • cost-effectiveness

    Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)

    2 years

Secondary Outcomes (4)

  • Frequency of comprehensive eye examination taken by rural doctors

    2 years

  • comprehensive eye examination rate among patients in rural hospitals

    2 years

  • the usage rate of Electric-Record

    2 years

  • Cost-effectiveness of van

    2 years

Study Arms (2)

rural doctor

examine patient's fundus by 90D fundus pre-set lens

Device: 90 D

grader

grade fundus pictures in ZOC

Device: fundus camera and grader

Interventions

90 DDEVICE

rural doctors exam eye fundus by 90 D

rural doctor

taking fundus pictures and graded by graders in ZOC

grader

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

age \> 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients

You may qualify if:

  • age \> 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients

You may not qualify if:

  • unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, No.54, Xianlienan Road

Guangzhou, Guangdong, 510060, China

Location

Study Officials

  • Nathan Congdong, MD,MPH

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director,Blindness Prevention and Treatment Department

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 30, 2017

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations