AI-Powered DIY Screening System for Diabetic Retinopathy

March 18, 2025 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
  2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
  3. Provide written informed consent.

Exclusion Criteria:

  1. individuals with physical disabilities that prevent the use of a fundus camera, or
  2. individuals with speech impairments who are unable to complete telephone follow-ups.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Screening
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.
Diagnostic test: AI-powered fundus camera screening
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Consumer Acceptability
Time Frame: 3 months
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)).
3 months
Diagnostic Accuracy
Time Frame: 3 months
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.
3 months
Disease Detection Rates
Time Frame: 3 months
The detection rate is defined as the proportion of newly diagnosed DR cases divided by the total number of eligible individuals.
3 months
Adherence to Referral
Time Frame: 3 months
Patient adherence to referral will be measured as the proportion of patients who attend an ophthalmology service among the total number of referred patients.
3 months
Technical Feasibility: Quality of Image Acquisition
Time Frame: 3 months
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.
3 months
Cost-effectiveness of DIY Screening
Time Frame: 3 months
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.
3 months
Assessment of Consumer Satisfaction
Time Frame: 3 months
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.
3 months
Diagnostic Accuracy
Time Frame: 3 months
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.
3 months
Diagnostic Accuracy
Time Frame: 3 months
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.
3 months
Diagnostic Accuracy
Time Frame: 3 months
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.
3 months
Diagnostic Accuracy
Time Frame: 3 months
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.
3 months
Technical Feasibility:The duration of Clinic Flow
Time Frame: 3 months
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.
3 months
Technical Feasibility:Reporting and Impact on Clinic Flow
Time Frame: 3 months
The investigators will involve track any delays or disruptions in the clinic schedule.
3 months
Technical Feasibility: The type of technical error
Time Frame: 3 months
The investigators will maintain a log of technical errors encountered during the image acquisition process. This log will include the type of error.
3 months
Technical Feasibility: Number of Recorded Technical Errors
Time Frame: 3 months
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.
3 months
Technical Feasibility: Remedies for technical errors
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20231218003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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