Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05659940
Collaborator
(none)
66
1
10.9
6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    66 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Nov 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Changes of angiogenic neutrophils ratio [Inclusion (Day1)]

      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 LSRFortessaâ„¢ Cell Analyzer and cells are analyzed by FlowJo v10 software.

    Secondary Outcome Measures

    1. Corneal Neovascularization Score [Inclusion (Day1)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Diagnosed ocular chemical injury with or without corneal neovascularization.

    Exclusion Criteria:
    1. Those who are diagnosed ocular diseases except for chemical ocular injury, such as uveitis, retinopathy.

    2. Those who are diagnosed allergic disease, autoimmune diseases or hematological diseases, infectious disease, such as eczema, systemic lupus erythematosus (SLE), agranulocytosis and viral hepatitis.

    3. Those who took immunosuppressive treatments in the past 3 months.

    4. Pregnant or nursing women.

    5. Those who have serious heart, lung, liver or kidney diseases.

    6. Those who have serious systemic diseases.

    7. Those who performed ocular surgery (including cataract surgery) in recent three months.

    8. Those who have been enrolled in other interventional clinical studies at the same time.

    9. Those who are unable to complete the study according to the investigators' requirements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05659940
    Other Study ID Numbers:
    • 2022KYPJ226
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 21, 2022