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

NCT06756009 | Recruiting

• 1 other identifier: 2021KYPJ148
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Techniques, Ophthalmological; Liver Transplantation; Liver Cirrhoses

Keywords

Diagnostic Techniques, Ophthalmological; liver transplantation; Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The performance of the model in assessing the severity of liver disease

  1 year

Study Arms (3)

preoperative group

Registered liver transplant patients from preoperative to postoperative follow-up

Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination

Simple postoperative group

Follow up from after liver transplantation

Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination

Healthy control group

Healthy individuals without liver disease

Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination

Interventions

Ophthalmic examination DIAGNOSTIC_TEST

Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.

Healthy control group; Simple postoperative group; preoperative group

General Condition Examination DIAGNOSTIC_TEST

Various general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc.

Healthy control group; Simple postoperative group; preoperative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Zizheng Cao, M.D.

CONTACT

+86-13201672078; caozzh@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: March 1, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)