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临床试验/NCT00992355
NCT00992355已完成不适用

Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

Veroia General Hospital1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2009年1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
发起方
入组人数
97
试验地点
1

研究概览

简要总结

This randomized controlled trial compares two regimens of topical therapy:

  • tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
  • combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

  • corneal edema
  • conjunctival redness
  • anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

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
None

入排标准

年龄范围
55 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Phacoemulsification (due to cataract)
  • Uneventful phacoemulsification surgery

排除标准

  • Disruption of the anterior lens capsule
  • Age-related macular degeneration
  • Proliferative diabetic retinopathy

研究组 & 干预措施

Tobramycin 0.3% - Dexamethasone 0.1%

Active Comparator

干预措施: Tobramycin 0.3% - Dexamethasone 0.1% (Drug)

Tobramycin-Dexamethasone plus Ketorolac tromethamine

Active Comparator

干预措施: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% (Drug)

研究者

发起方
Veroia General Hospital
申办方类型
Other

研究点 (1)

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