A Prospective, Randomized, Double-blind, Controlled Clinical Study of Corneal Debridement to Treat the Traumatic Corneal Abrasion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- wound recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants didn't know where they were grouped,and the experimenters did not know about the trial either.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: corneal debridement of corneal abrasion (Biological)
结局指标
主要结局
wound recurrence
时间窗: month 12 after treatment
Wound recurrence during 12 months after treatment.
次要结局
- 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.)