A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images

Recruiting

• Conditions: Deep Learning; Jaundice; Hyperbilirubinemia; Sclera

• Registration Number: NCT06421844
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks.

Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method.

The study duration is estimated to be 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-20
• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-06-20
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps.

Exclusion Criteria

Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis.

Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots).

Subjects who are unable to provide informed consent.

Elimination Criteria:

Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination.

Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loss of predicted bilirubin levels	Immediately after test completion	Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model.
Classification accuracy	Immediately after test completion	Classification accuracy for the jaundice severity grading model

Trial Locations

Locations (1)

First Affiliated Hospital of Air Force Military Medical University; 🇨🇳 Xi'an, Shaanxi, China