Diabetic Retinopathy
Conditions
Brief 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) 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.
Interventions
DEVICEFull Self-Diagnostic device in a remote diagnostic imaging site
Full Self-Diagnostic CRP+OCT imaging, followed by online consultation
DEVICEHuman imager operated diagnostic device in the hospital
Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Inclusion criteria
1. who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up 2. who are diagnosed with diabetes and aged between 30 years and 80 years 3. be able to sit for an imaging device for image acquisition 4. be capable of giving their own consent
Exclusion criteria
1\. who are pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy in the diagnosis of referral retinal lesions | 1 week | Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The agreement between the two modalities | 1 week | kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions |
| Feasibility of self-testing diagnosis imaging model | 1 week | Feasibility is measured by examination completion rate |
| Satisfaction of participants as measured by questionnaire | 1 week | Satisfaction is measured by a questionnaire between the two modalities |
Countries
China
Outcome results
None listed