NCT04592068

Brief Summary

The objective of this study is to establish deep learning (DL) algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. The effectiveness and accuracy of the established algorithm will be evaluated in community derived dataset.

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 11, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 13, 2020

Last Update Submit

December 9, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Area under curve

    We will use the receiver operating characteristic (ROC) curve to examine the ability of recognition and classification of diseases. Taken the results of the expert panel as the gold standard, we will use the area under curve to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

    1 week

  • Sensitivity and specificity

    Taken the results of the expert panel as the gold standard, we will use sensitivity and specificity to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

    1 week

  • Positive and negative predictive value

    Taken the results of the expert panel as the gold standard, we will use positive and negative predictive value to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

    1 week

  • Accuracy

    Taken the results of the expert panel as the gold standard, we will use accuracy to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

    1 week

Study Arms (2)

Retinal multi-diseases diagnosed by DL algorithm

Device: Retinal multi-diseases diagnosed by DL algorithm

Retinal multi-diseases diagnosed by expert panel

Other: Retinal multi-diseases diagnosed by expert panel

Interventions

DL algorithm automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.

Retinal multi-diseases diagnosed by DL algorithm

Expert panel classifies multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.

Retinal multi-diseases diagnosed by expert panel

Eligibility Criteria

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

community derived dataset

You may qualify if:

  • fundus photography around 45° field which covers optic disc and macula
  • complete patient identification information;

You may not qualify if:

  • incomplete patient identification information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-Bin Wei

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Gu C, Wang Y, Jiang Y, Xu F, Wang S, Liu R, Yuan W, Abudureyimu N, Wang Y, Lu Y, Li X, Wu T, Dong L, Chen Y, Wang B, Zhang Y, Wei WB, Qiu Q, Zheng Z, Liu D, Chen J. Application of artificial intelligence system for screening multiple fundus diseases in Chinese primary healthcare settings: a real-world, multicentre and cross-sectional study of 4795 cases. Br J Ophthalmol. 2024 Feb 21;108(3):424-431. doi: 10.1136/bjo-2022-322940.

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

December 11, 2020

Record last verified: 2020-10

Locations