MedTrace Logo

Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

NCT05223556 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167

Last updated 2023-04-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223556 on ClinicalTrials.gov