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临床试验/NCT00347204
NCT00347204已完成4 期

Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK

Center For Excellence In Eye Care0 个研究点目标入组 40 人开始时间: 2006年1月1日最近更新:
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相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
主要终点
Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK

研究概览

简要总结

To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

详细描述

Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.

Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.

In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.

Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing PRK for myopia or hyperopia

排除标准

  • 未提供

结局指标

主要结局

Prevention of postoperative discomfort on postoperative days 1 to 5 after PRK

Best-corrected Visual acuity at all study visits

Degree of corneal haze at all study visits

Time to epithelial closure in each eye after PRK

次要结局

未报告次要终点

研究者

发起方
Center For Excellence In Eye Care
申办方类型
Other

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