Diabetic RetinopathyNCT05223556
Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT)… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Full Self-Diagnostic device in a remote diagnostic imaging site and Human imager operated diagnostic device in the hospital
- Type of treatment
- Medical device
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 30 Dec 2022
- 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 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Participants from Shaoguan diabetic cohort
Who may be able to join
- who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up
- who are diagnosed with diabetes and aged between 30 years and 80 years
- be able to sit for an imaging device for image acquisition
- be capable of giving their own consent
Who cannot join
- 1. who are pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional CRP imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist.
Within one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.
- Conditions
- Diabetic Retinopathy
- Being tested
- Full Self-Diagnostic device in a remote diagnostic imaging site, Human imager operated diagnostic device in the hospital
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Self-Diagnostic device in a remote diagnostic imaging siteDevice
Full Self-Diagnostic CRP+OCT imaging, followed by online consultation
Human imager operated diagnostic device in the hospitalDevice
Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation
| Study group | Role | What they receive |
|---|---|---|
| Shaoguan Diabetic cohort | Patients with diabetes ages 30-80 were enrolled in Shaoguan Diabetic Eye Screening Programme, who will receive diabetic retinopathy screening both in a remote diagnostic imaging site and in a tertiary hospital Receives: Device: Full Self-Diagnostic device in a remote diagnostic imaging site; Device: Human imager operated diagnostic device in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy in the diagnosis of referral retinal lesions
Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging
Measured: 1 week
Secondary outcomes (4)
The agreement between the two modalities
kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions
Measured: 1 week
Feasibility of self-testing diagnosis imaging model
Feasibility is measured by examination completion rate
Measured: 1 week
Feasibility of self-testing diagnosis imaging model
Feasibility is measured by interpretable image rate
Measured: 1 week
Satisfaction of participants as measured by questionnaire
Satisfaction is measured by a questionnaire between the two modalities
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223556
- Sponsor's protocol ID
- 2020KYPJ201
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05223556
- Acronym / sponsor ID
- 2020KYPJ201
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- 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.
This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional CRP imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist.
Within one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shaoguan Diabetic cohort | – | Device: Full Self-Diagnostic device in a remote diagnostic imaging site, Device: Human imager operated diagnostic device in the hospitalPatients with diabetes ages 30-80 were enrolled in Shaoguan Diabetic Eye Screening Programme, who will receive diabetic retinopathy screening both in a remote diagnostic imaging site and in a tertiary hospital |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants from Shaoguan diabetic cohort
Key inclusion criteria (4 listed)
- who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up
- who are diagnosed with diabetes and aged between 30 years and 80 years
- be able to sit for an imaging device for image acquisition
- be capable of giving their own consent
Key exclusion criteria (1 listed)
- 1. who are pregnant or nursing women
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 |
|---|---|---|
| Full Self-Diagnostic device in a remote diagnostic imaging siteFull Self-Diagnostic CRP+OCT imaging, followed by online consultation | Device | Shaoguan Diabetic cohort |
| Human imager operated diagnostic device in the hospitalHuman imager operated CRP imaging with dilated pupils, followed by face-to-face consultation | Device | Shaoguan Diabetic cohort |
Primary outcome
Accuracy in the diagnosis of referral retinal lesions
Time frame: 1 week
Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging
4 secondary outcomes
The agreement between the two modalities
Time frame: 1 week
Feasibility of self-testing diagnosis imaging model
Time frame: 1 week
Feasibility of self-testing diagnosis imaging model
Time frame: 1 week
Satisfaction of participants as measured by questionnaire
Time frame: 1 week
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 4 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Retinopathy, run by Zhongshan Ophthalmic Center, 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 4 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 4 Apr 2023. 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 in the diagnosis of referral retinal lesions (time frame: 1 week). 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 4 Apr 2023.