NCT05659940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 7, 2023

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

December 5, 2022

Last Update Submit

March 5, 2023

Conditions

Outcome Measures

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.

    Inclusion (Day1) and 1 week

Secondary Outcomes (1)

  • Corneal Neovascularization Score

    Inclusion (Day1) and 1 week

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Diagnosed ocular chemical injury with or without corneal neovascularization.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood is collected in EDTA coated tube.

MeSH Terms

Conditions

Corneal Neovascularization

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 21, 2022

Study Start

January 1, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

March 7, 2023

Record last verified: 2022-11

Locations