Clinical trial NCT06421844: A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images
Official title: A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Jaundice
Deep Learning
Hyperbilirubinemia
Sclera
Keywords: Smart phone
Hyperbilirubinemia
Real-time
Deep learning
Sclera
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 270
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population Description:

The study will include a total of 270 patients, both male and female, aged 14 years and above. The participants should not have any pre-existing conditions that may affect the color of their sclera. They should be able to follow instructions and complete the scleral imaging procedure. The patient population will primarily consist of individuals undergoing treatment for colorectal polyps, pancreatitis, pancreatic tumors, hepatobiliary stones, or biliary tract tumors.

Screening Procedure:

Potential participants will be screened using oral queries to assess their eligibility based on the inclusion and exclusion criteria. A brief ocular examination will be performed to rule out any apparent ocular surface disorders. Eligible participants will be provided with a detailed explanation of the study objectives, procedures, and potential risks and benefits. Written informed consent will be obtained from all participants prior to enrollment in the study.

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.


Eligibility 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.

Primary outcomes:
measure: Loss of predicted bilirubin levels
timeFrame: Immediately after test completion
measure: Classification accuracy
timeFrame: Immediately after test completion
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Air Force Military Medical University
state: Shaanxi
Study officials:
References:
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