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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Self-Diagnostic device in a remote diagnostic imaging site | Device | Full Self-Diagnostic CRP+OCT imaging, followed by online consultation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy in the diagnosis of referral retinal lesions | Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| The agreement between the two modalities | kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions | 1 week |
| Feasibility of self-testing diagnosis imaging model |
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Inclusion Criteria:
Exclusion Criteria:
1. who are pregnant or nursing women
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Participants from Shaoguan diabetic cohort
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Human imager operated diagnostic device in the hospital | Device | Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation |
|
Feasibility is measured by examination completion rate
| 1 week |
| Feasibility of self-testing diagnosis imaging model | Feasibility is measured by interpretable image rate | 1 week |
| Satisfaction of participants as measured by questionnaire | Satisfaction is measured by a questionnaire between the two modalities | 1 week |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |