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临床试验/CTRI/2014/12/005288
CTRI/2014/12/005288已完成不适用

Comparison of intraocular pressure with Icare tonometer and applanation tonometer in paediatric age group

Father Muller Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
comparison of the iop measured between two instruments

研究概览

简要总结

Accurate measurement of intraocularpressure (IOP) is a vital component in the screening, diagnosis and managementof paediatric glaucoma. Goldmann applanation tonometry (GAT) has been the goldstandard method for IOP measurement in adults, but many new alternative methodsand devices have been developed in the last few years.Newermethods for IOP measurement are necessitated by certain limitations of GAT,which include its invasiveness, need for topical anaesthesia, slit-lampmounting with sitting posture, and disinfection of tonometer head after eachuse,  requirement of an experiencedtechnician, variability of readings depending on corneal material properties,curvature and thickness, and inaccuracy in post-refractive surgery eyes.

The invasiveness of GAT is a majorlimiting factor in the pediatric population, especially in younger children,who do not cooperate and resist eye examination. A tonometer thatproduces less sensations on eye contact may be more acceptable to children, whoare usually anxious and uncooperative when touched in their eyes by GAT.

The Icare tonometer® is a rebound tonometer(RBT) that operates on the principle of measuring the motion parameters of aprobe that bounces back after making contact with the eye, with higher IOPsresulting in faster rebounds. The impact of the sensor againstcentral cornea is minimal and six readings are obtained in rapid successionwithout eliciting the blink reflex. Icare is a portable device, doesn’t requiretopical anesthesia, can be hand-held few millimetres away from the eye, all ofwhich may be less frightening to children. The probe in icaretonometer has a disposable tip that obviates need for disinfection, but canalso be potentially reused after disinfection with less chances ofcrossifection. In addition, icare can be handled effectively evenby less experienced tonometrists. Previous studies in adults have shownthat IOP values measured with Icare tonometry (ICT) have a positive biascompared to values of GAT, but ICT can be a reliable method due to its goodcorrelation with GAT, both in healthy and glaucomatous eyes.

Inthe pediatric age group, ICT is a comfortable, accurate and reproducible methodwith high rates of successful IOP measurement and has been observed to reduce theneed for anesthesia. ICT has been reported to be one ofthe preferred methods for IOP measurement in children less than ten-years inreal life clinical settings.

Thepurpose of this study was to compare the agreement in IOP readings taken withGoldmann applanation tonometer and ICare® rebound tonometer in a normal paediatriccohort.

Null Hypothesis:

IOP measured by Icare tonometer will be not significantly different from that measured by the comparator gold standard Goldmann applanation tonometer

IOP measured by Icare tonometer will have good correlation (Pearsons correlation) and agreement (Bland-Altmann method) with Goldmann applanation tonometer

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
7.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Informed consent by parents/guardians.
  • Normal children aged 7-14 years presenting for ophthalmology evaluations to the department clinic during the study period.
  • Those children who can cooperate with measurement of IOP by Goldmann applanation tonometer and Icare tonometer.

排除标准

  • children with a history of glaucoma, ocular surface disorders like allergic conjunctivitis, infections, corneal scarring, eye trauma, and previous ocular surgeries.
  • 2.Uncooperative children and those who were squeezing the lids during the Icare readings were also excluded.

结局指标

主要结局

comparison of the iop measured between two instruments

时间窗: Point measure -Single measurement by two instruments with around 5 minutes gap on same day

次要结局

  • Correlation and agreement between the two instrument readings(Point measure -Single measurement by two instruments with around 5 minutes gap on same day)

研究者

发起方
Father Muller Medical College
申办方类型
Private medical college

研究点 (1)

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