Back to resultsValidation of an Artificial Intelligence System for Postoperative Management of Cataract Patients
Primary Purpose
Cataract, Postoperative Complications, Artificial Intelligence
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
An artificial intelligence system for postoperative management of cataract patients
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract focused on measuring Conjunctival hyperemia, Pterygium, Intraocular lens dislocation, Posterior capsule opacification, Pupil malformation, Suppurative endophthalmitis
Eligibility Criteria
Inclusion Criteria:
- Patients who had surgery of cataract extraction combined with introcular lens implantation.
- Patients should be aware of the contents and signed for the informed consent.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eligible patients for AI test
Arm Description
Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center.
Outcomes
Primary Outcome Measures
The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.
Secondary Outcome Measures
Full Information
NCT ID
NCT04138771
First Posted
October 23, 2019
Last Updated
December 1, 2019
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China, Xidian University
1. Study Identification
Unique Protocol Identification Number
NCT04138771
Brief Title
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients
Official Title
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2013 (undefined)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China, Xidian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Postoperative Complications, Artificial Intelligence
Keywords
Conjunctival hyperemia, Pterygium, Intraocular lens dislocation, Posterior capsule opacification, Pupil malformation, Suppurative endophthalmitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eligible patients for AI test
Arm Type
Experimental
Arm Description
Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center.
Intervention Type
Device
Intervention Name(s)
An artificial intelligence system for postoperative management of cataract patients
Intervention Description
This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.
Primary Outcome Measure Information:
Title
The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.
Time Frame
Up to 7 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who had surgery of cataract extraction combined with introcular lens implantation.
Patients should be aware of the contents and signed for the informed consent.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaohang Wu, M.D., Ph.D
Phone
8615913177657
Email
wuxiaohang_zoc@qq.com
12. IPD Sharing Statement
Learn more about this trial
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients
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