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临床试验/NCT00865540
NCT00865540Unknown4 期

Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies

Clinica Oftamologica Zona Sul1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
试验地点
1
主要终点
pupil size

研究概览

简要总结

The main objective of this study is to compare the effect of preoperative use of anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine 0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.

详细描述

Will be conducted with a randomized clinical trial volunteers with indication of extraction in Recife, Brazil. The surgical technique is employed phacoemulsification with implantation of intraocular lens. Digital photos are taken of the eye at the beginning and end of surgery and with them will be digitally determined the relationship between the corneal area and pupillary area. Each volunteer will be drawn to one of four groups of study (group 1, prednisolone acetate 1%, group 2, of ketorolac tromethamine 0.4%, 0.1% nepafenac group 3 and group 4, placebo). For the volunteers randomly selected for each group will be prescribed medication in its presentation as eye drops (Prednisolone acetate 1%, Pred Fort ®, Allergan ®; of ketorolac tromethamine 0.4%, incite l ®, Allergan ®; Nepafenac 0.1%, Nevanac ® Alcon ® and 0.5% methylcellulose, Fresh Tears ®, Allergan ®), 01 drop every 8 hours for 48 hours before surgery. For all volunteers will also be prescribed gatifloxacin (Zymar ®), 01 drop every 8 hours starting 48 hours before surgery. Was scheduled a minimum sample of 60 volunteers (15 per group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Carriers of senile cataract (> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia

排除标准

  • Using systemic anti-hormonal and non-hormonal
  • Using topical ocular medication (including anti-glaucomatous)
  • Individuals with congenital ocular abnormalities and cases in which there is intra-operative complications (hernia or trauma in the iris, posterior capsule rupture or zônula and prolonged phacoemulsification time of ≥ 1 minute).
  • Volunteers with incipient nuclear cataract (density 1) or advanced (density 4) by the LOCS II classification (density of nuclear cataract ranked 1 to 4 (Chalk et al, 1989)

研究组 & 干预措施

prednisolone acetate 1%

Experimental

one drop every 8h two days before surgery

干预措施: prednisolone acetate 1% (Drug)

ketorolac tromethamine 0.4%

Experimental

one drop every 8h two days before surgery

干预措施: ketorolac tromethamine 0.4% (Drug)

nepafenac 0.1%

Experimental

one drop every 8h two days before surgery

干预措施: nepafenac 0.1% (Drug)

placebo

Placebo Comparator

one drop every 8h two days before surgery

干预措施: methylcellulose 0.5% (Drug)

结局指标

主要结局

pupil size

时间窗: 1 day

次要结局

未报告次要终点

研究者

发起方
Clinica Oftamologica Zona Sul
申办方类型
Other

研究点 (1)

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