A Multi-center Study on the Artificial Intelligence Enabled Diabetic Retinopathy Screening Based on Fundus Images

NCT03602989 | Unknown

• 1 other identifier: AIDRScreening
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

Early detection and intervention of diabetic retinopathy (DR) is critical in preventing DR-related vision loss among type 1 (T1DM) and type 2 diabetic mellitus (T2DM) patients, currently estimated at over 100 million in China alone. Yet the healthcare resources, particularly retinal specialists, are in short supply and unevenly distributed. In order to help address this enormous mismatch and implement population-based screening, an artificial intelligence (AI) enabled, cloud based software is developed by training a custom-built convolutional neural network. This study is designed to evaluate the safety and efficacy of such device in detecting referable diabetic retinopathy (moderate non-proliferative DR or worse).

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  To evaluate the sensitivity and specificity of the device in detecting referable DR (more than mild NPDR)

  No more than 1 day for each subject

Interventions

AI-enabled Diabetic Retinopathy Screening Software DEVICE

Color fundus images of both eyes are captured on site before being uploaded to and analyzed by the cloud-based Artificial Intelligence software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with T1DM and T2DM under clinical setting. Invitation to volunteer

You may qualify if:

• Subject must understand the study, has chosen to participate voluntarily, and has signed informed consent
• Age 18 or older, no limitations on gender identity
• Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus

You may not qualify if:

• As it is difficult to obtain fundus images of satisfactory quality with small pupils, mydriasis is advisable under certain circumstances except if:
• the subject is allergic to mydriatic drugs;
• the subject's intraocular pressure (IOP) ≥ 22 mmHg;
• the subject is prone to post-dilation angle closure, pupillary block, etc.;
• The subject has refractive media opacity and/or pupil abnormalities that affect fundus examination and imaging;
• The subject has severe vitreous hemorrhage;
• The subject has received fundus laser treatment;
• The subject is participating in other ophthalmic clinical trials;
• In cases when the researchers believe the subject is not suitable for taking fundus photograph, including but not limited to:
• The subject had nystagmus and could not obtain a gradable fundus photograph;
• other disqualifying condition deemed by the researcher.

Sponsors & Collaborators

• Shenzhen SiBright Co., Ltd.: lead
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator
• Peking University People's Hospital: collaborator
• The Eye Hospital of Wenzhou Medical University: collaborator

Study Sites (3)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaofeng Lin, M.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 27, 2018
• Study Start: July 5, 2018
• Primary Completion: November 30, 2018
• Study Completion: August 31, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

CN (3)