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临床试验/NCT01998568
NCT01998568已完成不适用

The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Intraocular pressure

研究概览

简要总结

The investigators conduct this study to access the effect of corneal edema (the investigators are particularly interested in those who have the clinical central corneal edema) on the variation of intraocular pressure values measured by 3 commercial-available tonometers compare to the current gold standard tonometer; Goldmann applanation tonometer.

详细描述

Previous published articles reported on the effect of corneal edema on the accuracy of tonometry were performed in enucleated cadaver eyes, or contact lens-induced corneal edema eyes. Thus, it remains unclear as to how the clinical corneal edema that is found in routine clinical practice will affect the variation of intraocular pressure measurement using the standard Goldmann applanation tonometer and other more modern tonometers such as the dynamic contour tonometer, the iCare, and the Tonopen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age more than 18 year-old
  • Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
  • Agree to participate in the study and willing to sign an informed consent

排除标准

  • Combined phacoemulsification and trabeculectomy
  • Clear cornea phacoemulsification that has suture on the cornea
  • Previous history of intraocular surgery, ocular trauma prior to phacoemulsification
  • Vitrectomized eye
  • History of glaucoma or ocular hypertension or using IOP lowering medication
  • History of diabetic retinopathy staged as severe non-proliferative or worse
  • Pregnant or breast-feeding women
  • History of refractive surgery or any keratoplastic procedure
  • Corneal opacities or diseases making no suitable tonometry
  • Severe dry eye syndrome
  • Wears contact lenses
  • Astigmatism higher than 2.5 diopters
  • Microphthalmos or buphthalmos
  • Subjects with having poor or eccentric fixation or nystagmus
  • Excessive eye squeezing
  • Known allergy to topical anesthesia
  • Known allergy to fluorescein solution

结局指标

主要结局

Intraocular pressure

时间窗: A day after cataract surgery and when the corneal edema is resolve (usually within 1-2 weeks post operatively)

The intraocular pressure measured by each tonometer compare with Goldmann applanation tonometer (When measure in eyes with corneal edema and when the edema is clinically resolve)

次要结局

  • Relationship between the central corneal thickness and intraocular pressure measured by each tonometer(A day after surgery (clinical corneal edema was detected) and within 1-2 weeks (resolution of edema))

研究者

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

Weerawat Kiddee

Doctor

Prince of Songkla University

研究点 (1)

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