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临床试验/NCT07274176
NCT07274176已完成不适用

The Effect of Graded Forced Expiration on Intraocular Pressure: A Study Using the Airofit Device

Uşak University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月15日最近更新:
干预措施

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
Intraocular Pressure Measurement

研究概览

简要总结

The primary objective of this study is to utilize the Airofit device to systematically measure and characterize the changes in intraocular pressure across its six different levels of forced expiration. This investigation will provide crucial quantitative data on the IOP-respiratory effort relationship, enhancing our understanding of IOP dynamics during controlled respiratory stress and establishing a new, standardized paradigm for such research.

详细描述

Intraocular pressure (IOP) is a key physiological parameter and the primary modifiable risk factor for glaucoma. Its dynamic nature is well-documented, with fluctuations known to occur due to a variety of factors, including posture, time of day, and bodily maneuvers. The Valsalva maneuver-forced exhalation against a closed glottis-is a classic example of a physiological stressor that can cause a transient, sharp increase in IOP. This occurs due to a rise in intrathoracic and episcleral venous pressure, impeding the outflow of aqueous humor.

While the effect of a maximal Valsalva is recognized, the quantitative relationship between graded levels of expiratory force and IOP remains poorly characterized. Previous studies have been limited by the inability to precisely control and measure respiratory effort, often relying on voluntary maneuvers that lack standardization and reproducibility.

The recent advent of portable respiratory muscle trainers, such as the Airofit device, offers a novel solution to this methodological challenge. This device enables the precise application of controlled, graded resistance to expiration across multiple predefined levels.

Therefore, the primary objective of this study is to utilize the Airofit device to systematically measure and characterize the changes in intraocular pressure across its six different levels of forced expiration. This investigation will provide crucial quantitative data on the IOP-respiratory effort relationship, enhancing our understanding of IOP dynamics during controlled respiratory stress and establishing a new, standardized paradigm for such research.

Methods

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older.
  • Willing and able to provide informed consent.
  • Have a best-corrected visual acuity of 6/12 or better.
  • Able to understand and follow instructions for using the Airofit device.
  • Have an optic nerve cup/disc ratio not exceeding 0.5, and have a c/d difference between both eyes not exceeding 0.
  • Did not have taken any anticholinergic medication, systemic beta-blockers, or corticosteroids within the last 3 months that could affect intraocular pressure levels.

排除标准

  • a history of intraocular surgery,
  • a history of uveitis,
  • a spherical refractive error exceeding 3D,
  • a history of regular topical treatment other than artificial tears

研究组 & 干预措施

Forced expiration program

Experimental

The participants will be equipped with the Airofit respiratory muscle trainer and will be provided with standardised instructions on performing forced expiration manoeuvres.

Participants will be fitted with the Airofit respiratory muscle trainer and given standardized instructions on performing forced expiration maneuvers.

  • The protocol consisted of sequentially performing forced expiration at each of the device's six predefined resistance levels (Level 1 being the lowest, Level 6 the highest).

  • The sequence for each level will be identical and as follows:

  • Exercise Phase: The participant will perform forced expiration maneuvers with the Airofit device for a duration of 5 minute at the specified resistance level.

  • Immediate Post-Exercise Measurement: Within 5 seconds of completing the exercise minute, IOP will be measured. This measurement will be labeled accordingly: T1 (after Level 1), T2 (after Level 2), up to T6 (after Level 6).

干预措施: Intraocular Pressure after forced expiration (Other)

结局指标

主要结局

Intraocular Pressure Measurement

时间窗: T0: Baseline / T1: after 1 minute of forced expiration at Level 1 /T2: after 1 minute of forced expiration at Level 2/T3: Immediately after 1 minute of forced expiration at Level 3

The intraocular pressure will be measured in both eyes using a calibrated Tonoref III non-contact tonometry (Nidek Co., Ltd., Gamagori, Aichi, Japan) and applanation tonometry (A900 tonometer, Costruzione Strumenti Oftalmici, Firenze, Italy) by a single examiner

次要结局

未报告次要终点

研究者

发起方
Uşak University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Yavuz Karahan

Professor

Uşak University

研究点 (2)

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