A Prospective, Randomized, Double-blind, Controlled Clinical Study of Corneal Debridement to Treat the Traumatic Corneal Abrasion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- wound recurrence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The participants didn't know where they were grouped,and the experimenters did not know about the trial either.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
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.
Intervention: corneal debridement of corneal abrasion (Biological)
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.
Intervention: corneal debridement of corneal abrasion (Biological)
Outcomes
Primary Outcomes
wound recurrence
Time Frame: month 12 after treatment
Wound recurrence during 12 months after treatment.
Secondary Outcomes
- Incidence of wound infection(week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.)
- The grading of pain for eyes(week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.)
- Corneal scar(week 1, week 2, month 1, month 2, month 3, month 6, month 9, and month 12.)