Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223556
• Other study ID #: 2020KYPJ201
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Feasibility of self-testing diagnosis imaging model	Feasibility is measured by examination completion rate	1 week
Secondary	Feasibility of self-testing diagnosis imaging model	Feasibility is measured by interpretable image rate	1 week
Secondary	Satisfaction of participants as measured by questionnaire	Satisfaction is measured by a questionnaire between the two modalities	1 week