The Debridement To Treat The Traumatic Corneal Abrasion

Corneal Abrasion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534217
• Other study ID #: 2022KYPJ139
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 31, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Zhaohui Yuan, Doctor's degree
• Phone: 13570961208
• Email: yuanzhaohui.[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Abrasion
• Corneal Injuries

Intervention

Biological:
• corneal debridement of corneal abrasion
Surgical debridement for traumatic corneal epithelial abrasions

Locations

Country	Name	City	State
China	Zhaohui Yuan	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound recurrence	Wound recurrence during 12 months after treatment.	month 12 after treatment
Secondary	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.
Secondary	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.
Secondary	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.