Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters

Recruiting

• Conditions: Diagnostic Techniques, Ophthalmological; Liver Transplantation; Liver Cirrhoses

• Registration Number: NCT06756009
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The performance of predicting the prognosis of liver transplantation	1 week and 1 year after liver transplantation	Based on the outcomes of early graft dysfunction and 1-year graft survival rate, the area under the receiver operating characteristic curve, specificity, and sensitivity of the model

Secondary Outcome Measures

Name	Time	Method
The performance of the model in assessing the severity of liver disease	1 year	The confusion matrix of the model based on the MELD score results

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China