Artificial Intelligence-assisted Glaucoma Screening (AIAGS)

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03682783
• Collaborator: (none)
• Enrollment: 8,000
• Location: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 216.4

Study Details

Study Description

Brief Summary

This study will develop an artificial intelligence (AI) program for the screening of glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Eye	Diagnostic Test: Fundus Image

Detailed Description

We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention.

China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 8000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Development of Artificial Intelligence-assisted Glaucoma Screening Program
• Anticipated Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Oct 1, 2020
• Anticipated Study Completion Date: Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Fundus Image Glaucomatous and Non-glaucomatous fundus images that have been taken from the last 5 years in Shanghai General hospital.	Diagnostic Test: Fundus Image; Fundus image of optic nerve

Outcome Measures

Primary Outcome Measures

1. The specificity of the algorithm for diagnosing glaucoma [from January 2020 to March 2021]

   The specificity of the algorithm for diagnosing glaucoma will be calculated ...

2. The sensitivity of the algorithm for diagnosing glaucoma [from January 2020 to March 2021]

   The sensitivity of the algorithm for diagnosing glaucoma will be calculated .

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• able to complete fundus images

Exclusion Criteria:

• unable to complete fundus images

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai General Hospital	Shanghai	Shanghai	China	200080

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Haiyan Wang, Ph.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiyan Wang, Attending of Ophthalmology, M.D. Ph.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT03682783
• Other Study ID Numbers: 81300776
• First Posted: Sep 25, 2018
• Last Update Posted: Sep 25, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haiyan Wang, Attending of Ophthalmology, M.D. Ph.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: Artificial Intelligence; Glaucoma
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Sep 25, 2018