0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the incidence of recurrent corneal epithelium exfoliation
研究概览
简要总结
Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.
0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definitive diagnosis of primary corneal epithelial abrasion;
- •Monocular onset;
- •Corneal epithelium was defected and fluorescein sodium staining was positive.
排除标准
- •Corneal epithelial defect complicated with infection
- •Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)
- •Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases
研究组 & 干预措施
experience
干预措施: 0.3% Sodium Hyaluronate Eye Drop (Drug)
结局指标
主要结局
the incidence of recurrent corneal epithelium exfoliation
时间窗: 6 month
Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
次要结局
- the incidence of recurrent corneal epithelium exfoliation(1 year)
- corneal fluorescein staining score(1 year)
- Corneal edema grading(1 year)
研究者
Fang Duan
clinical professor
Sun Yat-sen University