NCT05223556

Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	Full Self-Diagnostic device in a remote diagnostic imaging site	Full Self-Diagnostic CRP+OCT imaging, followed by online consultation
DEVICE	Human imager operated diagnostic device in the hospital	Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-02-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: China