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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03903042

Enrollment

300

Registered

2019-04-04

Start date

2018-11-01

Completion date

2019-05-31

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Aurora fundus camera, Artificial intelligence, Diabetic retinopathy

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Image Quality of Aurora camera	within 3 months	Score of Image Quality

Secondary

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

Countries

China

Outcome results