NCT05682105

Brief Summary

Our study presents a detection model predicting a diagnosis of jaundice (clinical jaundice and occult jaundice) trained on prospective cohort data from slit-lamp photos and smartphone photos, demonstrating the model's validity and assisting clinical workers in identifying patient underlying hepatobiliary diseases.

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
1,633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3.9 years

First QC Date

December 26, 2022

Last Update Submit

January 10, 2023

Conditions

Keywords

OphthalmologyArtificial Intelligenceocualr imageJaundice

Outcome Measures

Primary Outcomes (1)

  • area under the receiver operating characteristic curve of the deep learning system

    The investigators will calculate the area under the receiver operating characteristic curve of deep learning system

    baseline

Secondary Outcomes (1)

  • sensitivity and specificity of the deep learning system

    baseline

Study Arms (2)

Development dataset

Slit-lamp images collected from the Department of Hepatobiliary Surgery of the Third Affiliated Hospital of Sun Yat-sen University(HTH), Affiliated Huadu Hospital of Southern Medical University(HDH), and Nantian Medical Centre of Aikang Health Care (NMC).

Testing dataset

Slit-lamp and smartphone images collected from the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University(ITH), Huanshidong Medical Centre of Aikang Health Care, the Medical Centre of the Third Affiliated Hospital of Sun Yat-sen University(MCH).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This prospective, multicentre, observational study was led by Zhongshan Ophthalmic Centre (ZOC), Sun Yat-sen University, and conducted in three phases to collect data from participants from three surgery departments and three medical examination centres, including the Department of Hepatobiliary Surgery of the Third Affiliated Hospital of Sun Yat-sen University (HTH; Guangzhou, China), the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University (ITH; Guangzhou, China), the Department of Infectious Diseases, the Affiliated Huadu Hospital of Southern Medical University (HDH; Guangzhou, China), the Medical Centre of the Third Affiliated Hospital of Sun Yat-sen University(MCH; Guangzhou, China), Nantian Medical Centre of Aikang Health Care (NMC), and Huanshidong Medical Centre of Aikang Health Care (HMC).

You may qualify if:

  • The quality of slit-lamp images should be clinical acceptable. More than 90% of the slit-lamp image area, including three central regions (sclera, pupil, and lens) are easy to read and discriminate.

You may not qualify if:

  • Images with light leakage (\>10% of the area), spots from lens flares or stains, and overexposure were excluded from further analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Digestive System DiseasesJaundice

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 12, 2023

Study Start

December 1, 2018

Primary Completion

October 30, 2022

Study Completion

June 30, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations