Diagnostic Techniques, OphthalmologicalNCT06756009
Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters
An observational study of Diagnostic Techniques, Ophthalmological and Liver Transplantation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study investigates the correlation between ocular biological characteristics and overall conditions before and after liver transplantation by collecting ocular biological characteristics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Techniques, Ophthalmological, Liver Transplantation, Liver Cirrhoses
- What is being tested?
- Ophthalmic examination and General Condition Examination
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, +86-13802793086, linht5@mail.sysu.edu
Xiaohang Wu, M.D., Ph.D, +86-15913177657, wxhang@mail2.sysu.edu.cn
About this study
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.
Read the 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.
- Being tested
- Ophthalmic examination, General Condition Examination
- Keywords
- Diagnostic Techniques, Ophthalmological, liver transplantation, Liver Cirrhoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic examinationDiagnostic test
Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.
General Condition ExaminationDiagnostic test
Various general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc.
| Study group | Role | What they receive |
|---|---|---|
| preoperative group | Registered liver transplant patients from preoperative to postoperative follow-up Receives: Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination | |
| Simple postoperative group | Follow up from after liver transplantation Receives: Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination | |
| Healthy control group | Healthy individuals without liver disease Receives: Diagnostic Test: Ophthalmic examination; Diagnostic Test: General Condition Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week and 1 year after liver transplantation
Secondary outcomes (1)
The performance of the model in assessing the severity of liver disease
The confusion matrix of the model based on the MELD score results
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Mar 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Techniques, OphthalmologicalStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Zhongshan People's Hospital, Guangdong, China, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756009
- Sponsor's protocol ID
- 2021KYPJ148
- Status last verified
- Aug 2024
- First submitted
- 25 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters
- ClinicalTrials.gov ID
- NCT06756009
- Acronym / sponsor ID
- 2021KYPJ148
- Keywords
- Diagnostic Techniques, Ophthalmological, liver transplantation, Liver Cirrhoses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Zhongshan People's Hospital, Guangdong, China, First People's Hospital of Foshan
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preoperative group | – | Diagnostic Test: Ophthalmic examination, Diagnostic Test: General Condition ExaminationRegistered liver transplant patients from preoperative to postoperative follow-up |
| Simple postoperative group | – | Diagnostic Test: Ophthalmic examination, Diagnostic Test: General Condition ExaminationFollow up from after liver transplantation |
| Healthy control group | – | Diagnostic Test: Ophthalmic examination, Diagnostic Test: General Condition ExaminationHealthy individuals without liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic examinationVarious ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc. | Diagnostic test | Healthy control group, Simple postoperative group, preoperative group |
| General Condition ExaminationVarious general condition examination, including blood pressure measurement, blood glucose testing, blood routine examination, coagulation function test, liver function test, etc. | Diagnostic test | Healthy control group, Simple postoperative group, preoperative group |
Primary outcome
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
1 secondary outcome
The performance of the model in assessing the severity of liver disease
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Techniques, Ophthalmological and Liver Transplantation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zizheng Cao, M.D. (+86-13201672078, caozzh@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of predicting the prognosis of liver transplantation (time frame: 1 week and 1 year after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.