ClinicalTrials.gg
Status unknownNCT05659940Updated Mar 7, 2023

Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.

An observational study in Corneal Neovascularization and Neutrophils, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
66
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Corneal Neovascularization
  • Neutrophils
03

In context

Corneal Neovascularization

29 studies on the registry are indexed under Corneal Neovascularization; 4 are open to participants now.

Browse Corneal Neovascularization studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Diagnosed ocular chemical injury with or without corneal neovascularization.

Exclusion criteria

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, diseases or hematological diseases, infectious disease, such as eczema, systemic lupus erythematosus (SLE), agranulocytosis and viral hepatitis.
  3. Those who took 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
66 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Inclusion (Day1) and 1 week

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Nov 2023, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2022
First posted
Dec 21, 2022
StartActual
Jan 1, 2023
Primary completionEst.
Nov 30, 2023
CompletionEst.
Nov 30, 2023
Last update
Mar 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05659940
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Jan 1, 2023
Primary completion
Nov 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Mar 7, 2023

Study contacts

Ziqi Yang
Contact
yangzq6@mail2.sysu.edu.cn
8618826227484

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion