Back to resultsValidation of the Utility of Myopia Intelligent Diagnostic System
Primary Purpose
Myopia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myopia Intelligent Diagnostic System
Sponsored by
About this trial
This is an interventional diagnostic trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Student aged 6-18
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eligible patients for AI test
Arm Description
Outcomes
Primary Outcome Measures
The AUC of the Myopia Intelligent Diagnostic System
Secondary Outcome Measures
The sensitivity of the Myopia Intelligent Diagnostic System
The specificity of the Myopia Intelligent Diagnostic System
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04014725
Brief Title
Validation of the Utility of Myopia Intelligent Diagnostic System
Official Title
Validation of the Utility of Myopia Intelligent Diagnostic System: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2019 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen 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
The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eligible patients for AI test
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Myopia Intelligent Diagnostic System
Intervention Description
An artificial intelligence to make diagnosis of myopia using ocular appearance images
Primary Outcome Measure Information:
Title
The AUC of the Myopia Intelligent Diagnostic System
Time Frame
up to 3 month
Secondary Outcome Measure Information:
Title
The sensitivity of the Myopia Intelligent Diagnostic System
Time Frame
up to 3 month
Title
The specificity of the Myopia Intelligent Diagnostic System
Time Frame
up to 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Student aged 6-18
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahan Yang
Phone
+8615521013933
Email
yah.yang39@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Validation of the Utility of Myopia Intelligent Diagnostic System
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