SPGC and Optometry Clinics
Hong Kong
Location status: Recruiting
NCT Number: NCT06892353
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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)).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 3 months
The investigators will involve track any delays or disruptions in the clinic schedule.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Mingguang He
CONTACT
Yanxian Chen
CONTACT
The Hong Kong Polytechnic University
Other
AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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