Diabetic RetinopathyNCT06892353
AI-Powered DIY Screening System for Diabetic Retinopathy
A study testing AI-powered fundus camera screening in people with Diabetic Retinopathy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- AI-powered fundus camera screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
- have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
- Provide written informed consent.
Who cannot join
- individuals with physical disabilities that prevent the use of a fundus camera, or
- individuals with speech impairments who are unable to complete telephone follow-ups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
SPGC and Optometry Clinics
Hong Kong
He Prof., 85234002795, mingguang.he@polyu.edu.hk
About this study
Official title: AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.
- Conditions
- Diabetic Retinopathy
- Being tested
- AI-powered fundus camera screening
- Keywords
- diabetic retinopathy, AI, screening system
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-powered fundus camera screeningDiagnostic test
All the participants will undertake an AI-powered fundus camera screening, physician/optometrist consultation, survey with questionnaires and a phone interview three months after their baseline assessment.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | All the participants will undertake an AI-powered fundus camera screening, physician/optometrist consultation, survey with questionnaires and a phone interview three months after their baseline assessment. Receives: Diagnostic Test: AI-powered fundus camera screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate without Active Assistant Help
Success rate of using the DIY screening booth help will be determined by the number of successful screening runs without active assistant help divided by the total number of screening runs.
Measured: 3 months
Secondary outcomes (16)
Assessment of Consumer Acceptability
Assessment of consumer acceptability will be determined by the positive response rate/screening rate (i.e. the total number of eligible patients who agree to screening (numerator) divided by the total number of eligible individuals (denominator)).
Measured: 3 months
Diagnostic Accuracy
All retinal images will be re-graded by two independent ophthalmologists, with any disagreements adjudicated by a third ophthalmologist (gold standard). This grading result will be considered as gold standard reference for the diagnostic accuracy of the automated screening. The indicators for diagnostic accuracy include: sensitivity.
Measured: 3 months
Disease Detection Rates
The detection rate is defined as the proportion of newly diagnosed DR cases divided by the total number of eligible individuals.
Measured: 3 months
Adherence to Referral
Patient adherence to referral will be measured as the proportion of patients who attend an ophthalmology service among the total number of referred patients.
Measured: 3 months
Technical Feasibility: Quality of Image Acquisition
The investigators will use a standardized checklist to assess the quality of images acquired during the study. This checklist will include criteria resolution, clarity, and completeness of the images. A sample of images will be reviewed by a panel of experts to ensure consistency and reliability in the assessment.
Measured: 3 months
Cost-effectiveness of DIY Screening
The cost-effective analyses will involve using the incremental cost-effectiveness ratio (ICER) as the key indicator to identify whether DIY screening model is a good investment.
Measured: 3 months
Assessment of Consumer Satisfaction
The responses to the 5-point Likert scale question will be analysed using the "document variable statistics" function in MAXQDA software. Data from the open-ended questionnaire will be analysed thematically. All themed information will be shared for review by project steering committee. The Likert scale ranges from 1 to 5. The content includes 5 options, including strongly disagree, disagree, neural, agree, strongly agree. The higher scores (e.g., 4 or 5) indicate a stronger agreement or a more positive attitude towards the statement, while lower scores (e.g., 1 or 2) indicate disagreement or a more negative attitude.
Measured: 3 months
Diagnostic Accuracy
All retinal images will be re-graded by two independent ophthalmologists, with any disagreements adjudicated by a third ophthalmologist (gold standard). This grading result will be considered as gold standard reference for the diagnostic accuracy of the automated screening. The indicators for diagnostic accuracy include: specificity.
Measured: 3 months
Diagnostic Accuracy
All retinal images will be re-graded by two independent ophthalmologists, with any disagreements adjudicated by a third ophthalmologist (gold standard). This grading result will be considered as gold standard reference for the diagnostic accuracy of the automated screening. The indicators for diagnostic accuracy include: accuracy.
Measured: 3 months
Diagnostic Accuracy
All retinal images will be re-graded by two independent ophthalmologists, with any disagreements adjudicated by a third ophthalmologist (gold standard). This grading result will be considered as gold standard reference for the diagnostic accuracy of the automated screening. The indicators for diagnostic accuracy include: positive/negative predictive values.
Measured: 3 months
Diagnostic Accuracy
All retinal images will be re-graded by two independent ophthalmologists, with any disagreements adjudicated by a third ophthalmologist (gold standard). This grading result will be considered as gold standard reference for the diagnostic accuracy of the automated screening. The indicators for diagnostic accuracy include: area under curve.
Measured: 3 months
Technical Feasibility:The duration of Clinic Flow
The investigators will conduct time-motion studies to evaluate the impact of the new imaging process on clinic flow. This will track the time taken for image acquisition, processing, and reporting and record the total time spent.
Measured: 3 months
Technical Feasibility:Reporting and Impact on Clinic Flow
The investigators will involve track any delays or disruptions in the clinic schedule.
Measured: 3 months
Technical Feasibility: The type of technical error
The investigators will maintain a log of technical errors encountered during the image acquisition process. This log will include the type of error.
Measured: 3 months
Technical Feasibility: Number of Recorded Technical Errors
The investigators will maintain a log of technical errors encountered during the image acquisition process. This log will record the frequency of each type of technical errors.
Measured: 3 months
Technical Feasibility: Remedies for technical errors
The investigators will maintain a log of technical errors encountered during the image acquisition process. This log will document any corrective actions taken in response to technical errors. Regular review meetings will be held to analyze these errors and implement strategies to minimize their occurrence.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892353
- Sponsor's protocol ID
- HSEARS20231218003
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06892353
- Acronym / sponsor ID
- HSEARS20231218003
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, AI, screening system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 24 Mar 2025 (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.
A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Diagnostic Test: AI-powered fundus camera screeningAll the participants will undertake an AI-powered fundus camera screening, physician/optometrist consultation, survey with questionnaires and a phone interview three months after their baseline assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
- have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
- Provide written informed consent.
Key exclusion criteria (2 listed)
- individuals with physical disabilities that prevent the use of a fundus camera, or
- individuals with speech impairments who are unable to complete telephone follow-ups.
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 |
|---|---|---|
| AI-powered fundus camera screeningAll the participants will undertake an AI-powered fundus camera screening, physician/optometrist consultation, survey with questionnaires and a phone interview three months after their baseline assessment. | Diagnostic test | Screening |
Primary outcome
Success Rate without Active Assistant Help
Time frame: 3 months
Success rate of using the DIY screening booth help will be determined by the number of successful screening runs without active assistant help divided by the total number of screening runs.
16 secondary outcomes
Assessment of Consumer Acceptability
Time frame: 3 months
Diagnostic Accuracy
Time frame: 3 months
Disease Detection Rates
Time frame: 3 months
Adherence to Referral
Time frame: 3 months
Technical Feasibility: Quality of Image Acquisition
Time frame: 3 months
Cost-effectiveness of DIY Screening
Time frame: 3 months
Assessment of Consumer Satisfaction
Time frame: 3 months
Diagnostic Accuracy
Time frame: 3 months
Diagnostic Accuracy
Time frame: 3 months
Diagnostic Accuracy
Time frame: 3 months
Diagnostic Accuracy
Time frame: 3 months
Technical Feasibility:The duration of Clinic Flow
Time frame: 3 months
Technical Feasibility:Reporting and Impact on Clinic Flow
Time frame: 3 months
Technical Feasibility: The type of technical error
Time frame: 3 months
Technical Feasibility: Number of Recorded Technical Errors
Time frame: 3 months
Technical Feasibility: Remedies for technical errors
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-powered fundus camera screening in people with Diabetic Retinopathy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingguang He (85234002795, mingguang.he@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate without Active Assistant Help (time frame: 3 months). 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 24 Mar 2025.