Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.

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.

Study Overview

• Status: Recruiting
• Conditions: Corneal Neovascularization; Neutrophils

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 Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Ziqi Yang; Phone Number: 8618826227484; Email: yangzq6@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Ziqi Yang, PhD; Phone Number: 8618826227484; Email: yangzq6@mail2.sysu.edu.cn
      • Principal Investigator: Xialin Liu, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion (Day1) and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion (Day1) and 1 week

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Metaplasia; Neovascularization, Pathologic; Corneal Neovascularization
• Other Study ID Numbers: 2022KYPJ226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No