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临床试验/NCT05523622
NCT05523622招募中不适用

Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Intraocular Pressure

研究概览

简要总结

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

详细描述

This is a comparative study between the TonoVera, the gold standard Goldmann Applanation Tonometry (GAT) and an established rebound tonometry device, iCare. IOP measurements will be obtained using the following devices: Reichert's prototype Tono-Vera Rebound tonometer (a rebound tonometer in development), iCare's iC100 rebound tonometer (a device commonly used in clinical practice), GAT (a device commonly used in clinical practice). Reichert's iPac Handheld Pachymeter (a device commonly used in clinical practice) will be used to measure the test subject's Central Corneal Thickness (CCT), measured in µm if CCT is not already on file. An Autorefractor Keratometer (ARK) (a device commonly used in clinical practice) will be used to measure necessary vision correction and corneal curvature. The Ocular Response Analyzer (a device commonly used in clinical practice) will be used to measure corneal hysteresis. Multiple IOP measurements will be taken with each device on each eye for all subjects: 3 along the central cornea, 3 along the peripheral cornea, and 3 along the sclera.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Ability to provide signed and dated informed consent form. Patients willing to comply with all study procedures and be available for the duration of the study.
  • Male or female patients aged 18 to 99 Patients in good general health as evidenced by ability to come to their appointment on day of study.

排除标准

  • Patients age less than 18 years Patients unable or unwilling to provide informed consent to participate in the study Patients for which an accurate tonometry reading cannot be performed. This may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.Patients with significant scleral thinning Patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the Goldmann tonometer.

研究组 & 干预措施

IOP Measurement

Other

These are the measurements of the intraocular pressure.

干预措施: Tono-Vera tonometer (Device)

IOP Measurement

Other

These are the measurements of the intraocular pressure.

干预措施: Goldman Applanation Tonometry (Device)

结局指标

主要结局

Intraocular Pressure

时间窗: Baseline only

pressure inside the eye

次要结局

未报告次要终点

研究者

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

Catherine Seeger

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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