Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Device: Full Self-Diagnostic device in a remote diagnostic imaging site; Device: Human imager operated diagnostic device in the hospital

• Registration Number: NCT05223556
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-22
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-04
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shaoguan Diabetic cohort	Full Self-Diagnostic device in a remote diagnostic imaging site	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
Shaoguan Diabetic cohort	Human imager operated diagnostic device in the hospital	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

Primary Outcome Measures

Name	Time	Method
Accuracy in the diagnosis of referral retinal lesions	1 week	Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China