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临床试验/NCT01553760
NCT01553760Unknown不适用

The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Corneal temperature

研究概览

简要总结

The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).

详细描述

Three-port Micro Incision Cataract Surgery (Tri-MICS) is a technique suggested by Professor Assia. The idea (principle) behind the Tri-MICS technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). An additional corneal incision is made for the introduction of a second surgical instrument, and a third for an ACM as an exclusive source for the infusion - this saves the need for an additional instrument. The ACM that will be used in this study (AVI New York) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. This type of ACM has been used in hundreds of surgeries and has been found to be both effective and safe.

This procedure has 4 clear advantages:

  1. The implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the Biaxial-MICS.
  2. This procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the MICS approach at the cost of tens of thousands of dollars.
  3. This procedure allows a free use of the surgeon's second hand.
  4. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • •Bilateral Cataract
  • •Ability to understand and sign on an inform consent form.
  • •whiling to undergo bilateral cataract surgery.

排除标准

  • •Mature Cataract
  • •Corneal Pathology
  • •Endothelial cell density<1500 cells/mm
  • •Extreme Hyperopia / shallow anterior chamber
  • •Extreme Myopia
  • •s/p Ophthalmic Trauma / Surgery
  • •Allergy to Penicillin / IOD

研究组 & 干预措施

Tri-MICS

Experimental

干预措施: Phacoemulsification using an ACM as the sole fluid source (Procedure)

Conventional Phaco

Active Comparator

干预措施: Conventional Phaco (Procedure)

结局指标

主要结局

Corneal temperature

时间窗: up to 12 months

Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system

次要结局

  • Anterior chamber stability(up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abulafia Adi

MD

Meir Medical Center

研究点 (1)

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