Clinical trial NCT05534217: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Abrasion
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients diagnosed with traumatic corneal epithelial abrasions are treated by complete debridement of the corneal epithelium
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound recurrence
timeFrame: month 12 after treatment
Secondary outcomes:
measure: Incidence of wound infection
timeFrame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
measure: The grading of pain for eyes
timeFrame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
measure: Corneal scar
timeFrame: week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhaohui Yuan
state: Guangdong
Study officials:
References: