Metaverse-assisted Diagnosis Imaging Model for Diabetic Retinopathy

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05223556
Collaborator
(none)
167
28

Study Details

Study Description

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 a Augmented Reality (AR)-assisted online consultation provided by virtual 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Full Self-Diagnostic device in a remote diagnostic imaging site
  • Device: Human imager operated diagnostic device in the hospital

Study Design

Study Type:
Observational
Anticipated Enrollment :
167 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Accuracy of a Metaverse-assisted Diagnosis Imaging Model for Diabetic Retinopathy
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
Full Self-Diagnostic CRP+OCT imaging, followed by AR-assisted online consultation

Device: Human imager operated diagnostic device in the hospital
Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation

Outcome Measures

Primary Outcome Measures

  1. Accuracy in the diagnosis of referral retinal lesions [1 week]

    Accuracy in the diagnosis of referral retinal lesions using the Metaverse-assisted diagnosis imaging

Secondary Outcome Measures

  1. 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

  2. Feasibility of Metaverse-assisted diagnosis imaging model [1 week]

    Feasibility is measured by examination completion rate

  3. Feasibility of Metaverse-assisted diagnosis imaging model [1 week]

    Feasibility is measured by interpretable image rate

  4. Satisfaction of participants as measured by questionnaire [1 week]

    Satisfaction is measured by a questionnaire between the two modalities

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05223556
Other Study ID Numbers:
  • 2020KYPJ201
First Posted:
Feb 4, 2022
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022