| CTRI Number |
CTRI/2025/08/092259 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative observational study |
| Study Design |
Other |
|
Public Title of Study
|
How ability to maintain balance differ in adults with and without vision difficulties |
|
Scientific Title of Study
|
Comparison of Vestibulo-Ocular Reflex in Adults with and without Myopia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreeya Srikanth |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902265840 |
| Fax |
|
| Email |
shreeya1.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan M M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845141575 |
| Fax |
|
| Email |
kishan.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishan M M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845141575 |
| Fax |
|
| Email |
kishan.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal - 576104 |
|
|
Primary Sponsor
|
| Name |
Shreeya Srikanth |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kishan M M |
Department of Speech and Hearing, Kasturba Hospital |
Room number 307, Research Lab, Kasturba Hospital, MAHE, Manipal, 576104
Udupi
KARNATAKA |
9845141575
kishan.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myopic and non myopic individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
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.
Post-enrolment exclusion of individuals who are diabetic based on ocular assessment findings.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study helps in establishing the impact of different degrees of myopia on vestibular functions |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |