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The Debridement To Treat The Traumatic Corneal Abrasion

Primary Purpose

Corneal Abrasion

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

corneal debridement of corneal abrasion

About this trial

This is an interventional prevention trial for Corneal Abrasion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The affected eye is traumatic corneal epithelial abrasion, and the specific criteria are as follows: A: Damage caused by one of the three high risk causes of recurrent corneal epithelial exfoliation defined as fingernails, paper, or plant leaves; B: Monocular disease; C: Eye pain, tears, photophobia and foreign body sensation when injured; D: Local defect of corneal epithelium was found at the time of injury, and fluorescein sodium staining was positive; E: The time from injury to first diagnosis is less than 24 hours.
Be between the ages of 18 and 60.
Patients volunteered to participate in the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

Corneal epithelial defect complicated with infection.
Patients with other ocular surface diseases (such as eyelid insufficiency, eyelid gland dysfunction, Sjogren's syndrome, bullae keratopathy, corneal dystrophy, drug induced corneal toxicity, etc.).
Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery;
Long-term contact lens wearers.
Pregnant or lactating women; Severe impairment of heart, liver and kidney function; One who is mentally abnormal; People with other inflammatory or autoimmune diseases. Corneal epithelial defect complicated with infection

Sites / Locations

Zhaohui Yuan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

debridement+traditional treatment

traditional treatment

Arm Description

The experimental group receives debridement of the abrasion wound before receiving traditional treatment including evofloxacin eye drops + befushu QID * for 14 days, four times a day, and the corneal contact lens was worn for 2 weeks.

The traditional group receives evofloxacin eye drops + befushu QID * for 14 days, four times a day, and the corneal contact lens was worn for 2 weeks.

Outcomes

Primary Outcome Measures

wound recurrence

Wound recurrence during 12 months after treatment.

Secondary Outcome Measures

Incidence of wound infection

The incidence of wound infection during 12 months after treatment.

The grading of pain for eyes

The degree of pain is evaluated during 12months after wounded. VRS（verbal rating scale）is used to evaluate the grading of pain,which is a line to describe the degrees of the pain that patients suffer from the disease, and the high scores is a worse outcome. The 5-point Verbal Rating Scale (VRS-5). （）Mild （）Discomforting （）Distressing （）Horrible （）Lxcruciaring

Corneal scar

It is evaluated by the doctor in follow-up during 12 months. The haze of the corneal scar，and the high scores is a worse outcome. The degrees : 0-clear cornea 0.5 - trace/just perceptible - easily seen with slit-lamp - moderate haze - pronounced haze, iris details still visible - "scarring", iris detail obscured (visible with pen torch)

Full Information

NCT ID

NCT05534217

First Posted

August 5, 2022

Last Updated

September 6, 2022

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05534217

Brief Title

The Debridement To Treat The Traumatic Corneal Abrasion

Official Title

A Prospective, Randomized, Double-blind, Controlled Clinical Study of Corneal Debridement to Treat the Traumatic Corneal Abrasion

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 31, 2022 (Anticipated)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Patients who signed informed consent to participate in the study will receive corneal epithelial deplasia. The patient was instructed to follow up closely in the following year, and the recurrence of the patient was collected through wechat follow-up.

Detailed Description

Traumatic corneal abrasion (TCA) refers to the injury or defect of the corneal epithelium caused by a foreign object (such as a nail, a tree branch, etc.), which is characterized by severe eye pain accompanied by red eyes, blepharospasm, photophobia, tearing, and a distinct foreign body sensation. TCA is one of the common eye injuries and ophthalmic emergencies, accounting for about 5%-10% in ophthalmic emergencies. Methods: The investigators conducted a clinical trial in adult patients with corneal trauma at the Zhongshan Ophthalmology Center of Sun Yat-sen University. Patients who signed informed consent to participate in the study were provided with corneal epithelial debridement. Patients were instructed to follow closely for the following year, and a pain log of the patient was collected at the last ophthalmology clinic visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Abrasion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients diagnosed with traumatic corneal epithelial abrasions are treated by complete debridement of the corneal epithelium

Masking

ParticipantOutcomes Assessor

Masking Description

The participants didn't know where they were grouped,and the experimenters did not know about the trial either.

Allocation

Randomized

Enrollment

156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

debridement+traditional treatment

Arm Type

Experimental

Arm Description

Arm Title

traditional treatment

Arm Type

Active Comparator

Arm Description

The traditional group receives evofloxacin eye drops + befushu QID * for 14 days, four times a day, and the corneal contact lens was worn for 2 weeks.

Intervention Type

Biological

Intervention Name(s)

corneal debridement of corneal abrasion

Intervention Description

Surgical debridement for traumatic corneal epithelial abrasions

Primary Outcome Measure Information:

Title

wound recurrence

Description

Wound recurrence during 12 months after treatment.

Time Frame

month 12 after treatment

Secondary Outcome Measure Information:

Title

Incidence of wound infection

Description

The incidence of wound infection during 12 months after treatment.

Time Frame

week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

Title

The grading of pain for eyes

Description

Time Frame

week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

Title

Corneal scar

Description

Time Frame

week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The affected eye is traumatic corneal epithelial abrasion, and the specific criteria are as follows: A: Damage caused by one of the three high risk causes of recurrent corneal epithelial exfoliation defined as fingernails, paper, or plant leaves; B: Monocular disease; C: Eye pain, tears, photophobia and foreign body sensation when injured; D: Local defect of corneal epithelium was found at the time of injury, and fluorescein sodium staining was positive; E: The time from injury to first diagnosis is less than 24 hours. Be between the ages of 18 and 60. Patients volunteered to participate in the study and signed the informed consent, showing good compliance. Exclusion Criteria: Corneal epithelial defect complicated with infection. Patients with other ocular surface diseases (such as eyelid insufficiency, eyelid gland dysfunction, Sjogren's syndrome, bullae keratopathy, corneal dystrophy, drug induced corneal toxicity, etc.). Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery; Long-term contact lens wearers. Pregnant or lactating women; Severe impairment of heart, liver and kidney function; One who is mentally abnormal; People with other inflammatory or autoimmune diseases. Corneal epithelial defect complicated with infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaohui Yuan, Doctor's degree

Phone

13570961208

yuanzhaohui.@gzzoc.com

Facility Information:

Facility Name

Zhaohui Yuan

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaohui Yuan, doctor

Phone

13570961208

yuanzhaohui.@gzzoc.com

12. IPD Sharing Statement

Plan to Share IPD

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The Debridement To Treat The Traumatic Corneal Abrasion

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