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

NCT ID: NCT06756009

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Diagnostic Techniques, Ophthalmological Liver Transplantation Liver Cirrhoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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preoperative group

Registered liver transplant patients from preoperative to postoperative follow-up

Ophthalmic examination

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Ophthalmic examination

Intervention Type 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

Intervention Type 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

Healthy individuals without liver disease

Ophthalmic examination

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ophthalmic examination

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital of Southern Medical University, Guangdong of China

UNKNOWN

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital, China

UNKNOWN

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zizheng Cao, M.D.

Role: CONTACT

+86-13201672078

Facility Contacts

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Haotian Lin, M.D., Ph.D

Role: primary

+86-13802793086

Xiaohang Wu, M.D., Ph.D

Role: backup

+86-15913177657

Other Identifiers

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2021KYPJ148

Identifier Type: -

Identifier Source: org_study_id

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