NCT03476291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 26, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 26, 2018

Last Update Submit

March 22, 2018

Conditions

Keywords

macular diseasesscreeningOCTDeep learningAI

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

no age limited, no gender-based

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Songtao Yuan, doctor

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 26, 2018

Study Start

June 30, 2017

Primary Completion

June 1, 2018

Study Completion

December 31, 2020

Last Updated

March 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations