Research of Automated Maculopathy Screening Based on AI Techniques Using OCT Images

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03476291
Collaborator
(none)
20,000
1
42.1
475.6

Study Details

Study Description

Brief Summary

The investigators expect to develop an algorithm that can interpret OCT images and automated determine whether the macula is normal or not by using OCT image-based deep learning techniques. And investigators wish to develop software applications that will help better screen and diagnose macular diseases in resource-limited areas.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators will apply deep learning convolutional neural network by using ImageNet for an automated detection of multiple retinal diseases with OCT horizontal B-scans with a high-quality labeled database. Datasets, including training dataset, testing dataset and validation datasets, will be built by ophthalmologists of the First affiliated hospital of Nanjing Medical University according to the standardized annotation guidelines.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Research of Automated Maculopathy Screening by Optical Coherent Tomography Image-based Deep Learning Techniques
    Actual Study Start Date :
    Jun 30, 2017
    Anticipated Primary Completion Date :
    Jun 1, 2018
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Normal

    normal macular structure of horizontal OCT B-scans

    Abnormal

    abnormal macular structure of horizontal OCT B-scans, including many sub-categories of pathological features, like epiretinal membrane, pigment epithelium detachment, ect.

    Outcome Measures

    Primary Outcome Measures

    1. receiver operating characteristic(ROC) curve of the algorithm [approximately 1 year]

      It is also called sensitivity curve. The ROC curve shows how sensitive the algorithm model is to automatically detect the desired output.

    2. Area under the ROC curve(AUC) [approximately 1 year]

      It shows the operating value of the algorithm model, which can represent the effect of the model.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All patients attending the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University within 5 years and who received known, clear diagnoses with digital retinal imaging (including OCT, fundus digital photographs and fundus fluorescein angiography, at least with OCT images) as part of their routine clinical care, will be eligible for inclusion in this study.
    Exclusion Criteria:
    • Hardcopy examinations (i.e., photos of paper reports of OCT imaging performed at other hospitals) will be ineligible.

    • Data from patients who have previously manually requested that their data should not be shared, even for research purposes in anonymised form, and have informed the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University of this desire (even in previously conducted studies or other on-going studies in this hospital), will be excluded, and their data will not be upload to the cloud platform before research begins.

    • Data from eyes tamponed with silicone oil or gas (i.e., C3F8) will be ineligible.

    • Data with poor image quality, such as incomplete images, inverted images, blurred or cracked images and images with a very weak signal (i.e., vitreous haemorrhage), will be ineligible.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu China 210029

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University

    Investigators

    • Principal Investigator: Songtao Yuan, doctor, The First Affiliated Hospital with Nanjing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT03476291
    Other Study ID Numbers:
    • JSPH-AIOCT-001
    First Posted:
    Mar 26, 2018
    Last Update Posted:
    Mar 26, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The First Affiliated Hospital with Nanjing Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 26, 2018