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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06756009
Enrollment
500
Registered
2025-01-01
Start date
2022-03-01
Completion date
2026-12-30
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Techniques, Ophthalmological, Liver Cirrhoses, Liver Transplantation

Keywords

Diagnostic Techniques, Ophthalmological, liver transplantation, Liver Cirrhoses

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.

Interventions

DIAGNOSTIC_TESTOphthalmic examination

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

DIAGNOSTIC_TESTGeneral Condition Examination

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

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Second Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Nanfang Hospital of Southern Medical University, Guangdong of China
CollaboratorUNKNOWN
Zhongshan People's Hospital, Guangdong, China
CollaboratorOTHER
Guangdong Provincial People's Hospital, China
CollaboratorUNKNOWN
First People's Hospital of Foshan
CollaboratorOTHER
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The performance of predicting the prognosis of liver transplantation1 week and 1 year after liver transplantationBased 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

MeasureTime frameDescription
The performance of the model in assessing the severity of liver disease1 yearThe confusion matrix of the model based on the MELD score results

Countries

China

Contacts

Primary ContactZizheng Cao, M.D.
caozzh@mail2.sysu.edu.cn+86-13201672078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026