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临床试验/NCT03275142
NCT03275142已完成不适用

Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining

Comprehensive EyeCare of Central Ohio2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Demonstration of corneal stability post-applanation with the Icare tonometer.

研究概览

简要总结

To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.

详细描述

Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Only the Investigator will be interpreting outcomes. The technician/care provider will perform all testing and will mask the investigator to which eye tonometry was performed.

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

  • 18 years of age

排除标准

  • Under 18 years of age

结局指标

主要结局

Demonstration of corneal stability post-applanation with the Icare tonometer.

时间窗: 30 minutes

Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale

次要结局

  • Difference in corneal staining pre and post-tonometry with ICare Tonometer.(10 minutes)
  • Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.(10 minutes)
  • Total cylinder differences pre and post-tonometry with ICare tonometer.(10 minutes)

研究者

发起方
Comprehensive EyeCare of Central Ohio
申办方类型
Other
责任方
Sponsor

研究点 (2)

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