Self-testing Diagnosis Imaging Model for Diabetic Retinopathy

NCT ID: NCT05223556

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Full Self-Diagnostic device in a remote diagnostic imaging site

Intervention Type DEVICE

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

Human imager operated diagnostic device in the hospital

Intervention Type DEVICE

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

Interventions

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Full Self-Diagnostic device in a remote diagnostic imaging site

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

Intervention Type DEVICE

Human imager operated diagnostic device in the hospital

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2020KYPJ201

Identifier Type: -

Identifier Source: org_study_id

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