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NCT Number: NCT06756009

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ophthalmic examination

Diagnostic Test

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

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.

Primary outcomes

  1. The performance of predicting the prognosis of liver transplantation

    Time frame: 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 outcomes

  1. The performance of the model in assessing the severity of liver disease

    Time frame: 1 year

    The confusion matrix of the model based on the MELD score results

Study contacts

Contact information is provided by the study sponsor or research team.

Zizheng Cao, M.D.

CONTACT

[email protected]

+86-13201672078

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • First People's Hospital of Foshan
  • Guangdong Provincial People's Hospital
  • Guangdong Provincial People's Hospital, China
  • Nanfang Hospital, Southern Medical University
  • Second Affiliated Hospital, Sun Yat-Sen University
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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