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OpenTrials
Completed

NCT Number: NCT05223556

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • who are pregnant or nursing women

Treatment and study plan

Full Self-Diagnostic device in a remote diagnostic imaging site

Device

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

Human imager operated diagnostic device in the hospital

Device

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

Primary outcomes

  1. Accuracy in the diagnosis of referral retinal lesions

    Time frame: 1 week

    Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging

Secondary outcomes

  1. The agreement between the two modalities

    Time frame: 1 week

    kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions

  2. Feasibility of self-testing diagnosis imaging model

    Time frame: 1 week

    Feasibility is measured by examination completion rate

  3. Feasibility of self-testing diagnosis imaging model

    Time frame: 1 week

    Feasibility is measured by interpretable image rate

  4. Satisfaction of participants as measured by questionnaire

    Time frame: 1 week

    Satisfaction is measured by a questionnaire between the two modalities

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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