The Debridement To Treat The Traumatic Corneal Abrasion

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Corneal Abrasion
• Intervention / Treatment: Biological: corneal debridement of corneal abrasion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaohui Yuan, Doctor's degree; Phone Number: 13570961208; Email: yuanzhaohui.@gzzoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhaohui Yuan
      • Contact: Zhaohui Yuan, doctor; Phone Number: 13570961208; Email: yuanzhaohui.@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Be between the ages of 18 and 60.
3. Patients volunteered to participate in the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

1. Corneal epithelial defect complicated with infection.
2. 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.).
3. Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery;
4. Long-term contact lens wearers.
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: debridement+traditional treatment; 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.	Biological: corneal debridement of corneal abrasion; Surgical debridement for traumatic corneal epithelial abrasions
Active Comparator: traditional treatment; 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.	Biological: corneal debridement of corneal abrasion; Surgical debridement for traumatic corneal epithelial abrasions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound recurrence	Wound recurrence during 12 months after treatment.	month 12 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound infection	The incidence of wound infection during 12 months after treatment.	week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
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	week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
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)	week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Corneal Diseases; Facial Injuries; Eye Injuries; Corneal Injuries
• Other Study ID Numbers: 2022KYPJ139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No