Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

NCT05223556 | Completed DMC

• 1 other identifier: 2020KYPJ201
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The agreement between the two modalities

  1 week

• Feasibility of self-testing diagnosis imaging model

  1 week

• Feasibility of self-testing diagnosis imaging model

  1 week

• Satisfaction of participants as measured by questionnaire

  1 week

Study Arms (1)

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

Interventions

Full Self-Diagnostic device in a remote diagnostic imaging site DEVICE

Full Self-Diagnostic CRP+OCT imaging, followed by online consultation

Shaoguan Diabetic cohort

Human imager operated diagnostic device in the hospital DEVICE

Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation

Shaoguan Diabetic cohort

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from Shaoguan diabetic cohort

You may qualify if:

• who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up
• who are diagnosed with diabetes and aged between 30 years and 80 years
• be able to sit for an imaging device for image acquisition
• be capable of giving their own consent

You may not qualify if:

• \. who are pregnant or nursing women

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 4, 2022
• Study Start: February 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)