The Debridement To Treat The Traumatic Corneal Abrasion

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Corneal Abrasion

Treatments: Biological: corneal debridement of corneal abrasion

Study type: Interventional

Funder types: Other

Identifiers

NCT05534217

2022KYPJ139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

156 participants in 2 patient groups

debridement+traditional treatment

Experimental group

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.

Treatment:

Biological: corneal debridement of corneal abrasion

traditional treatment

Active Comparator group

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.

Treatment:

Biological: corneal debridement of corneal abrasion