跳至主要内容
临床试验/NCT01070602
NCT01070602Unknown不适用

The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
the number of IFIS cases observed during operation.

研究概览

简要总结

Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate.

Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • cataract candidates treated (in the present or in the past) with tamsulosin
  • aged 55 or more
  • candidates for topical anesthesia
  • no allergy to anticholinergic or adrenergic drugs
  • able to understand and sign an informed consent

排除标准

  • history of uveitis
  • iris neovascularization
  • s/p iris surgery
  • traumatic/uveitis induced cataract
  • dialysis / abscence of zonules

研究组 & 干预措施

anterior corneal incision

Experimental

干预措施: anterior (more central) corneal paracentesis incision (Procedure)

结局指标

主要结局

the number of IFIS cases observed during operation.

时间窗: during the operations

次要结局

  • assessing the clinical grade of observed IFIS cases(during the operations)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验