Maculopathy Clinical Trial
Official title:
Research of Automated Maculopathy Screening by Optical Coherent Tomography Image-based Deep Learning Techniques
Verified date | February 2018 |
Source | The First Affiliated Hospital with Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 20000 |
Est. completion date | December 31, 2020 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | receiver operating characteristic(ROC) curve of the algorithm | It is also called sensitivity curve. The ROC curve shows how sensitive the algorithm model is to automatically detect the desired output. | approximately 1 year | |
Primary | Area under the ROC curve(AUC) | It shows the operating value of the algorithm model, which can represent the effect of the model. | approximately 1 year |
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