Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- corneal epithelial healing
研究概览
简要总结
Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK). Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has numerous serious complications, especially glaucoma. Loteprednol, a new generation of corticosteroid has less potency than dexamethasone and was proposed to has less side effect regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after PRK and risk of glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patient with epithelial defect after phototherapeutic keratectomy
排除标准
- •the patient with systemic disease such as diabetes and connective tissue disease
- •the patient with ocular surface disease such as dry eye and recurrent corneal erosion
研究组 & 干预措施
Loteprednol etabonate
Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks
干预措施: Dexamethasone (Drug)
Dexamethasone
Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks
干预措施: Loteprednol etabonate (Drug)
结局指标
主要结局
corneal epithelial healing
时间窗: 1 month
次要结局
- intraocular pressure(6 month)
研究者
Onsiri Thanathanee
othana
Khon Kaen University