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.
Study Type
OBSERVATIONAL
Enrollment
167
Full Self-Diagnostic CRP+OCT imaging, followed by online consultation
Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Accuracy in the diagnosis of referral retinal lesions
Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging
Time frame: 1 week
The agreement between the two modalities
kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions
Time frame: 1 week
Feasibility of self-testing diagnosis imaging model
Feasibility is measured by examination completion rate
Time frame: 1 week
Feasibility of self-testing diagnosis imaging model
Feasibility is measured by interpretable image rate
Time frame: 1 week
Satisfaction of participants as measured by questionnaire
Satisfaction is measured by a questionnaire between the two modalities
Time frame: 1 week
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