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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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract focused on measuring Cataract, Artificial Intelligence, Medical Referral Pattern

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 7, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Sun Yat-sen University
    Collaborators
    Xidian University
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    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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