NCT00414011已完成不适用
Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Corneal Epithelial Healing Time
研究概览
简要总结
The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
排除标准
- •Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- •Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- •Anterior basement membrane dystrophy.
- •History of recurrent epithelial erosion.
- •Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes)
- •Other corneal epithelial disorder or healing abnormality
研究组 & 干预措施
Moxifloxacin
Experimental
Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
干预措施: Moxifloxacin (Drug)
Gatifloxacin
Experimental
Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
干预措施: Gatifloxacin (Drug)
结局指标
主要结局
Corneal Epithelial Healing Time
时间窗: 3 to 4 days after surgery
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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