Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

NCT05223556 COMPLETED

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.

Details

Lead sponsor	Zhongshan Ophthalmic Center, Sun Yat-sen University
Status	COMPLETED
Enrolment	167
Start date	Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Diabetic Retinopathy

Interventions

• Full Self-Diagnostic device in a remote diagnostic imaging site
• Human imager operated diagnostic device in the hospital

Countries

China