Comparison of Aurora Fundus Camera With Traditional Camera in Diabetic Retinopathy With Visual Artificial Intelligence

April 3, 2019 updated by: Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Comparison of Aurora Fundus Camera With Traditional Fundus Camera in Diabetic Retinopathy With Phoebus Visual Artificial Intelligence

This study aims to compare the effect of Aurora handheld fundus camera with traditional desktop fundus camera in the fundus photography screening of diabetic patients, and to evaluate the effect of artificial intelligence algorithm in the diagnosis of diabetic retinopathy.

Study Overview

Status

Unknown

Conditions

Detailed Description

Aurora handheld fundus cameras are used to take fundus photography on diabetic patients in 3 ophthalmic diabetic retinopathy screening centers in China to compare its effect with the hospital's traditional desktop fundus camera, and evaluate the auxiliary diagnostic effect of Phoebus artificial intelligence algorithm in diabetic retinopathy.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed with diabetes, more than 18 years of age, male or female Chinese patients.

Description

Inclusion Criteria:

  1. Participants are more than 18 years of age, male or female Chinese patients;
  2. Diagnosed with diabetes;
  3. Prior written informed consent should be obtained

Exclusion Criteria:

  1. Patients with invisible fundus caused by any cause;
  2. Patients or his/her licensor unwill to sign an informed consent or follow this protocol;
  3. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Center 1: Traditional camera(Canon) vs Aurora camera
Group 2
Center 2: Traditional camera(Zeiss) vs Aurora camera
Group 3
Center 3: Traditional camera(Topcon) vs Aurora camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality of Aurora camera
Time Frame: within 3 months
Score of Image Quality
within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of gold standard
Time Frame: within 3 months
Gold standard: 8 photographs of one patient(4 by Aurora camera, 4 by traditional camera) by ophthalmologist（double blinded）
within 3 months
Image of Aurora camera
Time Frame: 1 month
Images taken by Aurora camera
1 month
Image of traditional camera (Center 1: Canon)
Time Frame: 1 month
Image taken by traditional camera（Center 1: Canon, pupil not dilated）
1 month
Image of traditional camera (Center 2: Zeiss)
Time Frame: 1 month
Image taken by traditional camera（Center 2: Zeiss, pupil dilated）
1 month
Image of traditional camera (Center 3: Topcon)
Time Frame: 1 month
Image taken by traditional camera（Center 3: Topcon, pupil dilated）
1 month
Outcome of artificial intelligence algorithm
Time Frame: 3 months
Outcome of artificial intelligence algorithm(Normal or Referral Required)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai1stAI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical Study Report will be published

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

Dr Fenghua Wang will review requests and criteria.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Retinopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe