Clinical trial NCT06756009: Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters
Official title: Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnostic Techniques, Ophthalmological
Liver Transplantation
Liver Cirrhoses
Keywords: Diagnostic Techniques, Ophthalmological
liver transplantation
Liver Cirrhoses
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Provincial People's Hospital
name: Nanfang Hospital of Southern Medical University, Guangdong of China
name: Zhongshan People's Hospital, Guangdong, China
name: Guangdong Provincial People's Hospital, China
name: First People's Hospital of Foshan
First posted: 2025-01-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The liver transplant population was recruited from individuals who went to cooperative medical unit for liver transplant registration, while normal individuals were recruited from the project responsible unit.

Brief summary: This study investigates the correlation between ocular biological characteristics and overall conditions before and after liver transplantation by collecting ocular biological characteristics. Explore whether it is possible to construct a clinical prediction model for liver transplantation by incorporating ocular biometric features, in order to optimize disease management before and after liver transplantation.

Detailed description: This study is a bidirectional cohort study, which retrospectively analysed data from a prospective database to construct a model, and prospectively collected patient information from preoperative to postoperative for model improvement and validation.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years old;
2. Late stage liver disease patients waiting for liver transplantation treatment, as well as patients with varying degrees of cirrhosis;
3. Can collect complete basic demographic information, liver function blood test indicators, liver pathology and imaging examination results;
4. Can cooperate with eye OCT, OCTA and other examinations, and obtain qualified examination parameters;
5. Voluntarily follow the clinical trial protocol and sign the informed consent form.

Exclusion Criteria:

1. History of other organ transplant surgeries;
2. History of intraocular laser treatment, medication injection, and surgery;
3. History of high myopia, glaucoma, and retinal choroidal related eye diseases;
4. History of major systemic diseases other than liver disease;
5. Individuals whose overall body and eye conditions cannot cooperate with eye examinations.

Primary outcomes:
measure: The performance of predicting the prognosis of liver transplantation
timeFrame: 1 week and 1 year after liver transplantation
Secondary outcomes:
measure: The performance of the model in assessing the severity of liver disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References: