Corneal NeovascularizationNCT05659940
Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.
An observational study of Corneal Neovascularization and Neutrophils, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether a novel subset of neutrophils is correlated with corneal neovascularization in the patients suffered from ocular chemical injury. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Neovascularization, Neutrophils
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients who come to Sun Yat-sen University Zhongshan Ophthalmic Center for medical care and healthy people who are volunteers recruited from society
Who may be able to join
- Diagnosed ocular chemical injury with or without corneal neovascularization.
Who cannot join
- Those who are diagnosed ocular diseases except for chemical ocular injury, such as uveitis, retinopathy.
- Those who are diagnosed allergic disease, autoimmune diseases or hematological diseases, infectious disease, such as eczema, systemic lupus erythematosus (SLE), agranulocytosis and viral hepatitis.
- Those who took immunosuppressive treatments in the past 3 months.
- Pregnant or nursing women.
- Those who have serious heart, lung, liver or kidney diseases.
- Those who have serious systemic diseases.
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- Those who performed ocular surgery (including cataract surgery) in recent three months.
- Those who have been enrolled in other interventional clinical studies at the same time.
- Those who are unable to complete the study according to the investigators' requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Ziqi Yang, PhD, 8618826227484, yangzq6@mail2.sysu.edu.cn
Xialin Liu, Prof.
About this study
The purpose of this study is to determine whether a novel subset of neutrophils is correlated with corneal neovascularization in the patients suffered from ocular chemical injury.
Read the detailed description
Cornea is an avascular transparent tissue providing refractive power for suitable optical performance. But under the condition of injury or infection, the stable microenvironment of ocular surface has been destroyed. Vessels sprout from the limbus to form corneal neovascularization, becoming an important pathological feature and leading cause of blindness. However, the underlying mechanism particular the inflammation-mediated mechanism remains unclear.
With the advancement of single-cell RNA sequencing (scRNA-seq), the investigation of immune cell transcriptomes has obtained great process . Using this advanced method, we identified different immune cell types in the ocular surface microenvironment in corneal neovascularization mouse model. Particularly, we found a specific subset of neutrophils played important role during the corneal angiogenesis. Using the loss-of-function and gain-of-function experiment, we clarified that this novel subset of neutrophils is the major factor that promoting corneal angiogenesis in mouse model. To further explore the relationship between this subset of neutrophils and angiogenesis in human, we plan to detect whether the neutrophil subset is increased in the circulation of chemical burned corneal neovascularization patients.
The main purpose of this study is to assess whether the novel subset of neutrophils has correlation with chemical burned corneal neovascularization. Approximately 33 patients and 33 age matched healthy controls will be recruited. The clinical characteristics, 4ml peripheral blood and the images of slit lamp photography will be obtained.
- Conditions
- Corneal Neovascularization, Neutrophils
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Healthy participants whose age and gender are consistent with CNV patients | |
| CNV patients | Patients who are diagnosed ocular chemical injury coming to Zhongshan Eye Center, Sun Yat-sen University for medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of angiogenic neutrophils ratio
Peripheral blood is collected in EDTA coated tubes and the red blood cells are lysed. The cells are firstly blocked and then stained the neutrophil subset markers. Flow cytometric analysis is performed at BD LSRFortessa™ Cell Analyzer and cells are analyzed by FlowJo v10 software.
Measured: Inclusion (Day1) and 1 week
Secondary outcomes (1)
Corneal Neovascularization Score
The neovascularization is scored on a scale of 0-3 as previously reported. 0 = no vessels; 1 = neovessels at the corneal limbus; 2 = neovessels spanning approaching the corneal center; 3 = neovessels spanning the central cornea.
Measured: Inclusion (Day1) and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NeovascularizationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659940
- Sponsor's protocol ID
- 2022KYPJ226
- Status last verified
- Nov 2022
- First submitted
- 5 Dec 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.
- ClinicalTrials.gov ID
- NCT05659940
- Acronym / sponsor ID
- 2022KYPJ226
- Conditions
- Corneal Neovascularization, Neutrophils
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 21 Dec 2022 (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.
The purpose of this study is to determine whether a novel subset of neutrophils is correlated with corneal neovascularization in the patients suffered from ocular chemical injury.
Detailed description
Cornea is an avascular transparent tissue providing refractive power for suitable optical performance. But under the condition of injury or infection, the stable microenvironment of ocular surface has been destroyed. Vessels sprout from the limbus to form corneal neovascularization, becoming an important pathological feature and leading cause of blindness. However, the underlying mechanism particular the inflammation-mediated mechanism remains unclear.
With the advancement of single-cell RNA sequencing (scRNA-seq), the investigation of immune cell transcriptomes has obtained great process . Using this advanced method, we identified different immune cell types in the ocular surface microenvironment in corneal neovascularization mouse model. Particularly, we found a specific subset of neutrophils played important role during the corneal angiogenesis. Using the loss-of-function and gain-of-function experiment, we clarified that this novel subset of neutrophils is the major factor that promoting corneal angiogenesis in mouse model. To further explore the relationship between this subset of neutrophils and angiogenesis in human, we plan to detect whether the neutrophil subset is increased in the circulation of chemical burned corneal neovascularization patients.
The main purpose of this study is to assess whether the novel subset of neutrophils has correlation with chemical burned corneal neovascularization. Approximately 33 patients and 33 age matched healthy controls will be recruited. The clinical characteristics, 4ml peripheral blood and the images of slit lamp photography will be obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | –Healthy participants whose age and gender are consistent with CNV patients |
| CNV patients | – | –Patients who are diagnosed ocular chemical injury coming to Zhongshan Eye Center, Sun Yat-sen University for medical care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients who come to Sun Yat-sen University Zhongshan Ophthalmic Center for medical care and healthy people who are volunteers recruited from society
Key inclusion criteria (1 listed)
- Diagnosed ocular chemical injury with or without corneal neovascularization.
Key exclusion criteria (9 listed)
- Those who are diagnosed ocular diseases except for chemical ocular injury, such as uveitis, retinopathy.
- Those who are diagnosed allergic disease, autoimmune diseases or hematological diseases, infectious disease, such as eczema, systemic lupus erythematosus (SLE), agranulocytosis and viral hepatitis.
- Those who took immunosuppressive treatments in the past 3 months.
- Pregnant or nursing women.
- Those who have serious heart, lung, liver or kidney diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of angiogenic neutrophils ratio
Time frame: Inclusion (Day1) and 1 week
Peripheral blood is collected in EDTA coated tubes and the red blood cells are lysed. The cells are firstly blocked and then stained the neutrophil subset markers. Flow cytometric analysis is performed at BD LSRFortessa™ Cell Analyzer and cells are analyzed by FlowJo v10 software.
1 secondary outcome
Corneal Neovascularization Score
Time frame: Inclusion (Day1) and 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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. This study is not recruiting at the moment.
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 Corneal Neovascularization and Neutrophils, 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziqi Yang (8618826227484, yangzq6@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of angiogenic neutrophils ratio (time frame: Inclusion (Day1) and 1 week). 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 7 Mar 2023.