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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation; Liver Cirrhoses; Diagnostic Techniques, Ophthalmological
• Intervention / Treatment: Diagnostic test: Ophthalmic examination; Diagnostic test: General Condition Examination

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Zizheng Cao, M.D.; Phone Number: +86-13201672078; Email: caozzh@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Haotian Lin, M.D., Ph.D; Phone Number: +86-13802793086; Email: linht5@mail.sysu.edu
      • Contact: Xiaohang Wu, M.D., Ph.D; Phone Number: +86-15913177657; Email: wxhang@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preoperative group; Registered liver transplant patients from preoperative to postoperative follow-up	Diagnostic test: Ophthalmic examination; Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.; Diagnostic test: General Condition Examination; Various general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc.
Simple postoperative group; Follow up from after liver transplantation	Diagnostic test: Ophthalmic examination; Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.; Diagnostic test: General Condition Examination; Various general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc.
Healthy control group; Healthy individuals without liver disease	Diagnostic test: Ophthalmic examination; Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.; Diagnostic test: General Condition Examination; Various general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The performance of predicting the prognosis of 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	1 week and 1 year after liver transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The performance of the model in assessing the severity of liver disease	The confusion matrix of the model based on the MELD score results	1 year

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Second Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People's Hospital; First People's Hospital of Foshan; Zhongshan People's Hospital, Guangdong, China; Nanfang Hospital of Southern Medical University, Guangdong of China; Guangdong Provincial People's Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: liver transplantation; Diagnostic Techniques, Ophthalmological; Liver Cirrhoses
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 2021KYPJ148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No