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Recruiting NCT06756009

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

— Observational Diagnostic Techniques, Ophthalmological Liver Transplantation Liver Cirrhoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ophthalmic examination, General Condition Examination.
Who it may be relevant to
Registry conditions: Diagnostic Techniques, Ophthalmological, Liver Transplantation, Liver Cirrhoses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The performance of predicting the prognosis of liver transplantation [Time frame: 1 week and 1 year after liver transplantation]
Secondary outcome measures (1)
  • The performance of the model in assessing the severity of liver disease [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06756009 · 2021KYPJ148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗