Using a smartphone app to measure bilirubin levels from eye images
A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images
This study is testing a smartphone app that takes pictures of the white part of the eye to see if it can accurately measure bilirubin levels and help identify jaundice in people aged 14 and older who are getting liver function tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06421844 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a smartphone application that measures serum bilirubin levels by analyzing images of the sclera (the white part of the eye). The study will assess the accuracy of bilirubin predictions and jaundice severity classifications using deep learning algorithms. Participants will be individuals aged 14 and older visiting the Gastroenterology Department for liver function tests. The study will last approximately three months and will utilize statistical methods to analyze the data collected.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 years or older who are visiting the Gastroenterology Department for liver function tests.
Not a fit: Patients with conditions that affect scleral color or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive, real-time method for monitoring bilirubin levels in patients with jaundice.
How similar studies have performed: While the use of smartphone applications for medical diagnostics is growing, this specific approach using scleral images for bilirubin measurement is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yanglin Pan, MD
- Email: yanglinpan@hotmail.com
- Phone: 86-13991811225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.