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

A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06421844
Enrollment
270
Registered
2024-05-20
Start date
2024-04-20
Completion date
2024-07-10
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Learning, Hyperbilirubinemia, Jaundice, Sclera

Keywords

Smart phone, Hyperbilirubinemia, Real-time, Deep learning, Sclera

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.

Interventions

None listed

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Loss of predicted bilirubin levelsImmediately after test completionStandard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model.
Classification accuracyImmediately after test completionClassification accuracy for the jaundice severity grading model

Countries

China

Contacts

Primary ContactYanglin Pan, MD
yanglinpan@hotmail.com86-13991811225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026