AI Classifies Multi-Retinal Diseases

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04592068
Collaborator
Beijing Tulip Partner Technology Co., Ltd, China (Other)
10,000
1
13
770.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Retinal multi-diseases diagnosed by DL algorithm
  • Other: Retinal multi-diseases diagnosed by expert panel

Detailed Description

Retinal diseases seriously threaten vision and quality of life, but they often develop insidiously. To date, deep learning (DL) algorithms have shown high prospects in biomedical science, particularly in the diagnosis of ocular diseases, such as diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, glaucoma, and papilledema. However, there is still a lack of a single algorithm that can classify multi-diseases from fundus photography.

This cross-sectional study will establish a DL algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. 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 evaluation indexes, such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Deep Learning-Based Automated Classification of Multi-Retinal Disease From Fundus Photography
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Retinal multi-diseases diagnosed by DL algorithm

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

Retinal multi-diseases diagnosed by expert panel

Other: Retinal multi-diseases diagnosed by expert panel
Expert panel classifies multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.

Outcome Measures

Primary Outcome Measures

  1. Area under curve [1 week]

    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.

  2. Sensitivity and specificity [1 week]

    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.

  3. Positive and negative predictive value [1 week]

    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.

  4. Accuracy [1 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • fundus photography around 45° field which covers optic disc and macula

  • complete patient identification information;

Exclusion Criteria:
  • incomplete patient identification information

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wen-Bin Wei Beijing Beijing China 100730

Sponsors and Collaborators

  • Beijing Tongren Hospital
  • Beijing Tulip Partner Technology Co., Ltd, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT04592068
Other Study ID Numbers:
  • Retinal multi diseases
First Posted:
Oct 19, 2020
Last Update Posted:
Dec 11, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 11, 2020