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临床试验/CTRI/2025/08/092259
CTRI/2025/08/092259尚未招募不适用

Comparison of Vestibulo-Ocular Reflex in Adults with and without Myopia

Shreeya Srikanth1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
This study helps in establishing the impact of different degrees of myopia on vestibular functions

研究概览

简要总结

This study aims to compare vestibular functioning in myopic and non-myopic individuals using Ocular Vestibular Evoked Myogenic Potentials and Subjective Visual Vertical, and to also assess the self-perceived impact of myopia on the participants using a questionnaire, Dizziness Handicap Inventory.

Participants within the age range of 18-40 years, with and without myopia will be recruited from various departments of Manipal College of Health Professions and will involve the student population. Written informed consent will be obtained, followed by screening, which involves ocular assessments to rule out other ocular conditions and confirm eligibility based on degree of myopia. Assessments will be conducted in the following sequence: ocular evaluation (15–20 minutes), completion of the functional component of the DHI (self-reported), Subjective Visual Vertical (SVV) testing using the Cyclops Balance eye system with VNG goggles (10–15 minutes), and Ocular Vestibular Evoked Myogenic Potentials (oVEMP) recording using the Intelligent Hearing Systems (IHS) Duet in a sound-treated room under EMG monitoring (30–40 minutes). Safety will be monitored during testing, and participants are free to withdraw at any time without penalty. No routine follow-up visits are planned.

Outcome measures:

Latency of N1-P1 peaks (millisecond)

Amplitude of N1-P1 peaks (Millivolt)

Amplitude Asymmetry Ratio (Percentage)

Angle of deviation from vertical (Degree) Clinical implications:

This study helps in understanding the impact of different degrees of myopia on vestibular functions

It helps tailor a specialized vestibular test battery for the population with myopia and dizziness

It can also help in the development of specific vestibular rehabilitation in vision-related dizziness conditions

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • INCLUSION CRITERIA Non-myopic group: Healthy adults without Myopia or any other vision-related disorders who are age and gender matched.
  • Myopic group: Individuals with Myopia Either spectacle and contact lens users.

排除标准

  • EXCLUSION CRITERIA Non myopic group: Individuals with a history of recurrent ear infections.
  • Individuals with Conductive Hearing loss.
  • Individuals with pre-existing balance difficulties due to organic disorders.
  • Individuals with other vision-related disorders such as hyperopia, retinopathy, retinal detachment, optic neuropathy, and cataracts.
  • Individuals with diagnosed neurological disorders and psychological disorders affecting balance.
  • Individuals with vision or vestibular impairments related to head trauma.
  • Individuals with visual or vestibular impairments secondary to systemic illnesses.
  • Post-enrolment exclusion of individuals who are diabetic based on ocular assessment findings.
  • Myopic group: Individuals with a history of recurrent ear infections.
  • Individuals with diagnosed Conductive Hearing loss.

结局指标

主要结局

This study helps in establishing the impact of different degrees of myopia on vestibular functions

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Shreeya Srikanth
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreeya Srikanth

Manipal College of Health Professions

研究点 (1)

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