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Trial record 2 of 5 for:    PHOEBUS
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Comparison of Aurora Fundus Camera With Traditional Camera in Diabetic Retinopathy With Visual Artificial Intelligence

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ClinicalTrials.gov Identifier: NCT03903042
Recruitment Status : Unknown
Verified April 2019 by Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
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.

Condition or disease
Diabetic Retinopathy

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Aurora Fundus Camera With Traditional Fundus Camera in Diabetic Retinopathy With Phoebus Visual Artificial Intelligence
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Image Quality of Aurora camera [ Time Frame: within 3 months ]
    Score of Image Quality


Secondary Outcome Measures :
  1. 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）

  2. Image of Aurora camera [ Time Frame: 1 month ]
    Images taken by Aurora camera

  3. Image of traditional camera (Center 1: Canon) [ Time Frame: 1 month ]
    Image taken by traditional camera（Center 1: Canon, pupil not dilated）

  4. Image of traditional camera (Center 2: Zeiss) [ Time Frame: 1 month ]
    Image taken by traditional camera（Center 2: Zeiss, pupil dilated）

  5. Image of traditional camera (Center 3: Topcon) [ Time Frame: 1 month ]
    Image taken by traditional camera（Center 3: Topcon, pupil dilated）

  6. Outcome of artificial intelligence algorithm [ Time Frame: 3 months ]
    Outcome of artificial intelligence algorithm(Normal or Referral Required)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were diagnosed with diabetes, more than 18 years of age, male or female Chinese patients.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903042


Locations
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China, Shanghai
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Fenghua Wang Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Publications:

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Responsible Party: Fenghua Wang, Doctoral Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03903042    
Other Study ID Numbers: Shanghai1stAI
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Clinical Study Report will be published
Supporting Materials: Clinical Study Report (CSR)
Time Frame: starting 6 months after publication
Access Criteria: Dr Fenghua Wang will review requests and criteria.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fenghua Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Aurora fundus camera
Artificial intelligence
Diabetic retinopathy
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases