Validation of a Universal Cataract Intelligence Platform
Primary Purpose
Cataract, Artificial Intelligence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cataract AI agent
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract focused on measuring Cataract, Artificial Intelligence, Medical Referral Pattern
Eligibility Criteria
Inclusion Criteria:
Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center.
Exclusion Criteria:
The patients who cannot cooperate with the examinations.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Artificial Intelligence
Arm Description
A universal diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of cataract.
Outcomes
Primary Outcome Measures
Diagnostic accuracy of the cataract AI agent
AUC: area under the receiver operating curve; accuracy (ACC) = (TP + TN) / (TP + TN + FP + FN); sensitivity (SEN) = TP / (TP + FN); specificity (SPE) = TN / (TN + FP); TP = true positive; TN = true negative; FP = false positive; FN = false negative.
Secondary Outcome Measures
Full Information
NCT ID
NCT03623971
First Posted
August 7, 2018
Last Updated
August 7, 2018
Sponsor
Sun Yat-sen University
Collaborators
Xidian University
1. Study Identification
Unique Protocol Identification Number
NCT03623971
Brief Title
Validation of a Universal Cataract Intelligence Platform
Official Title
Validation of the Utility of a Universal Cataract Intelligence Platform
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
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
This study established and validated a universal artificial intelligence (AI) platform for collaborative management of cataracts involving multi-level clinical scenarios and explored an AI-based medical referral pattern to improve collaborative efficiency and resource coverage.The datasets were labeled using a three-step strategy: (1) categorize slit lamp photographs into four separate capture modes; (2) diagnose each photograph as a normal lens, cataract or a postoperative eye; and (3) based on etiology and severity, further classify each diagnosed photograph for a management strategy of referral or follow-up. A deep residual convolutional neural network (CS-ResCNN) was used for the image classification task. Moreover, we integrated the cataract AI agent with a real-world multi-level referral pattern involving self-monitoring at home, primary healthcare, and specialized hospital services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Artificial Intelligence
Keywords
Cataract, Artificial Intelligence, Medical Referral Pattern
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artificial Intelligence
Arm Type
Experimental
Arm Description
A universal diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of cataract.
Intervention Type
Device
Intervention Name(s)
Cataract AI agent
Intervention Description
An artificial intelligence to make comprehensive evaluation and treatment decision of different types of cataracts.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of the cataract AI agent
Description
AUC: area under the receiver operating curve; accuracy (ACC) = (TP + TN) / (TP + TN + FP + FN); sensitivity (SEN) = TP / (TP + FN); specificity (SPE) = TN / (TN + FP); TP = true positive; TN = true negative; FP = false positive; FN = false negative.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center.
Exclusion Criteria:
The patients who cannot cooperate with the examinations.
12. IPD Sharing Statement
Learn more about this trial
Validation of a Universal Cataract Intelligence Platform
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