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Validation of a Universal Cataract Intelligence Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623971
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Xidian University
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
Diagnostic accuracy of the cataract AI agent [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of a Universal Cataract Intelligence Platform
Official Title  ICMJE Validation of the Utility of a Universal Cataract Intelligence Platform
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cataract
  • Artificial Intelligence
Intervention  ICMJE Device: Cataract AI agent
An artificial intelligence to make comprehensive evaluation and treatment decision of different types of cataracts.
Study Arms  ICMJE Experimental: Artificial Intelligence
A universal diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of cataract.
Intervention: Device: Cataract AI agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
500
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2017
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623971
Other Study ID Numbers  ICMJE CCPMOH2018- China7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haotian Lin, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Xidian University
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP