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

• Conditions: Maculopathy

• Registration Number: NCT03476291
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study Start: 2017-06-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Study First Posted: 2018-03-26
• Last Update Posted: 2018-03-26
• Primary Completion: 2018-06-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China