Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes.
研究概览
简要总结
The investigators performed this study to investigate pain prevention of preoperative topical nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time serial pain scoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 19 years of age
- •simultaneous bilateral PRK schedule
- •more than 400μm(including epithelium) of postoperative corneal thickness
- •less than 150μm of ablation depth.
排除标准
- •a history of ocular surgery or trauma
- •two-diopter more difference in spherical equivalent (SE) between the eyes,
- •keratoconus or other corneal pathology
- •use of systemic or topical NSAID within 1 month before the surgery
- •history of allergic reaction to aspirin or other NSAIDs
- •glaucoma or ocular hypertension (> 20 mmHg)
- •collagen vascular diseases
- •diabetic retinopathy
- •pregnancy or lactation
- •intraoperative complications.
研究组 & 干预措施
group KO
(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
干预措施: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) (Drug)
group DO
(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)
干预措施: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) (Drug)
结局指标
主要结局
Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes.
时间窗: Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK)
Through these postoperative pain score which rated time serially, the effect of pre-treated topical NSAIDs(ketorolac and diclofenac) could be investigated on relieving postoperative pain after PRK.
次要结局
未报告次要终点