Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

Sun Yat-sen University

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Device: Human imager operated diagnostic device in the hospital; Device: Full Self-Diagnostic device in a remote diagnostic imaging site

Study type: Observational

Funder types: Other

Identifiers

NCT05223556

2020KYPJ201

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

167 participants in 1 patient group

Shaoguan Diabetic cohort

Description:

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

Treatment:

Device: Full Self-Diagnostic device in a remote diagnostic imaging site

Device: Human imager operated diagnostic device in the hospital