Diabetes RetinopathyNCT01832077
Uptake of Telemedicine System Trial in Rual Canton
An observational study of Diabetes Retinopathy and Diabetes Macular Edema, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetes Retinopathy, Diabetes Macular Edema
- What is being tested?
- 90 D and fundus camera and grader
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to 30 Apr 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients
Who may be able to join
- age > 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients
Who cannot join
- unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, No.54, Xianlienan Road
Guangzhou, Guangdong, 510060
About this study
Official title: The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.
Read the 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.
- Conditions
- Diabetes Retinopathy, Diabetes Macular Edema
- Being tested
- 90 D, fundus camera and grader
- Keywords
- sensibility, specificity, positive predictive value, negative predictive value, Cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 DDevice
rural doctors exam eye fundus by 90 D
fundus camera and graderDevice
taking fundus pictures and graded by graders in ZOC
| Study group | Role | What they receive |
|---|---|---|
| rural doctor | examine patient's fundus by 90D fundus pre-set lens Receives: Device: 90 D | |
| grader | grade fundus pictures in ZOC Receives: Device: fundus camera and grader |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2 years
Secondary outcomes (4)
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)
Measured: 2 years
comprehensive eye examination rate among patients in rural hospitals
Frequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors.
Measured: 2 years
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.
Measured: 2 years
Cost-effectiveness of van
compare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2015
- Primary completion1 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes RetinopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdong, MD,MPH, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832077
- Sponsor's protocol ID
- ZOC-WDF-Telemedicine
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2013
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
- ClinicalTrials.gov ID
- NCT01832077
- Acronym / sponsor ID
- ZOC-WDF-Telemedicine
- Conditions
- Diabetes Retinopathy, Diabetes Macular Edema
- Keywords
- sensibility, specificity, positive predictive value, negative predictive value, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Orbis, The World Diabetes Foundation
- Study start
- Jan 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rural doctor | – | Device: 90 Dexamine patient's fundus by 90D fundus pre-set lens |
| grader | – | Device: fundus camera and gradergrade fundus pictures in ZOC |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients
Key inclusion criteria (1 listed)
- age > 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients
Key exclusion criteria (1 listed)
- unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90 Drural doctors exam eye fundus by 90 D | Device | rural doctor |
| fundus camera and gradertaking fundus pictures and graded by graders in ZOC | Device | grader |
Primary outcome
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)
4 secondary outcomes
Frequency of comprehensive eye examination taken by rural doctors
Time frame: 2 years
comprehensive eye examination rate among patients in rural hospitals
Time frame: 2 years
the usage rate of Electric-Record
Time frame: 2 years
Cost-effectiveness of van
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Congdong, MD,MPH principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Retinopathy and Diabetes Macular Edema, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading (time frame: 2 years after the telemedicine begin to use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.