Can images of the eyes be used to develop a reliable, non-invasive method for categorising the severity of jaundice?

Mechanised measurement of icterus from sclera tinge yellowness in hospital patients

Registry ID
ISRCTN11941403
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of York
Enrollment
100
Start date
2026-03-18
Completion date
2026-09-30
Last update
2026-08-17

Conditions

Summary

Symptoms and signs involving the digestive system and abdomen

Detailed description

Participants will be adult in-patients with blood bilirubin measurements available from routine blood tests taken as part of their standard care. Their initial location of treatment will include the Emergency Department, Medical and Surgical Wards, and High Dependency Units. The hospital’s biochemistry department will provide bilirubin test results, typically available within one to three hours after the blood sample is processed. Twice daily, the study manager will review the results to identify potential participants with serum bilirubin levels greater than 21 µmol/l. An equal number of patients with levels below 21 µmol/l will be randomly selected using a random number generator to form a control group. Identified individuals will be assessed against the inclusion and exclusion criteria. Those meeting any exclusion criteria will not be invited to participate. Eligible individuals will be approached by a research nurse, who will provide a participant information sheet explaining the study and obtain informed consent. Once consent is given, the participant’s eyes will be photographed to capture images of the sclera. This non-invasive process will take about 10 to 15 minutes. No additional blood tests or invasive procedures will be required, and participants can return to normal activities immediately after. The eye images will be linked to the participant’s recent bilirubin results to help train a machine-learning model for classifying jaundice severity. Participants will not need follow-up, and their involvement will end once imaging is complete. All data will be pseudonymised, with access restricted to authorised personnel. Participants can withdraw consent at any time without affecting their medical care.

Interventions

Inclusion criteria

1. Willing and able to give informed consent for participation in the study 2. Male, female, or other, aged 18 years and above 3. Able, in the investigator’s opinion, and willing to comply with all study requirements 4. Can be feasibly consented and measured within 48 hours of their blood test 5. Can be either mobile or immobile but must be capable of opening their eyes for the photograph 6. Currently admitted to the hospital as an inpatient 7. Deemed suitable to approach by the clinical ward team

Exclusion criteria

1. Intoxicated or under the undue influence of drugs or medications 2. Advanced eye pathology, as determined by the patient or clinician 3. Periorbital or orbital cellulitis 4. Implantable or non-removable contact lenses 5. Inability to obtain a scleral photographic image within 48 hours of the blood test 6. Epilepsy 7. Cataracts

Locations

Related clinical trials

View on source registry