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临床试验/NCT01506635
NCT01506635已完成不适用

Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年3月最近更新:
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
45
试验地点
1
主要终点
Spherical Equivalent

研究概览

简要总结

In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
  • cylinder ≤ -1.00 D,
  • corrected distance visual acuity (CDVA) of at least 20/40 were included.

排除标准

  • Patients with a history of previous ocular surgery,
  • keratoconus or any ectatic corneal disorder,
  • keratoconus suspect by topography,
  • preoperative corneal opacity,
  • any corneal dystrophies,
  • presence of pterygium,
  • retinal disorders,
  • collagen vascular disorders,
  • diabetes mellitus,
  • glaucoma,
  • cataract,
  • pregnancy,
  • breast feeding
  • systemic corticosteroid therapy were excluded.

研究组 & 干预措施

Control group

Placebo Comparator

included patients who received artificial tear twice a day as control group.

干预措施: Placebo (Drug)

Timolol group

Experimental

included the patients with myopic regression who received timolol 0.5% eye drop twice a day

干预措施: Timolol (Drug)

结局指标

主要结局

Spherical Equivalent

时间窗: spherical equivalent at month 6

Effect of timolol use in timolol group will be compared with placebo group at month 6. Moreover, the changes of intragroup spherical equivalent will be assessed in both group 6 months after timolol application.

次要结局

未报告次要终点

研究者

研究点 (1)

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