Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

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

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 Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Device: Human imager operated diagnostic device in the hospital; Device: Full Self-Diagnostic device in a remote diagnostic imaging site

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants from Shaoguan diabetic cohort

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shaoguan Diabetic cohort; 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	Device: Human imager operated diagnostic device in the hospital; Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation; Device: Full Self-Diagnostic device in a remote diagnostic imaging site; Full Self-Diagnostic CRP+OCT imaging, followed by online consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy in the diagnosis of referral retinal lesions	Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The agreement between the two modalities	kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions	1 week
Satisfaction of participants as measured by questionnaire	Satisfaction is measured by a questionnaire between the two modalities	1 week
Feasibility of self-testing diagnosis imaging model	Feasibility is measured by examination completion rate	1 week
Feasibility of self-testing diagnosis imaging model	Feasibility is measured by interpretable image rate	1 week

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2020KYPJ201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No