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CTRI Number  CTRI/2024/02/062435 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Gamification of Eye Tests using Virtual Reality  
Scientific Title of Study   Gamification of Visual Function Assessment using Virtual Reality  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishwas G Kini 
Designation  PhD Research Scholar 
Affiliation  Manipal Institute of Technology 
Address  Department of Computer Science Engineering, Academic Block 5, Manipal Institute of Technology, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902936204  
Fax    
Email  vishwas.g1@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr P C Siddalingaswamy 
Designation  Professor 
Affiliation  Manipal Institute of Technology 
Address  Department of Computer Science Engineering, Academic Block 5, Manipal Institute of Technology, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845094800  
Fax    
Email  pcs.swamy@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Krithica S 
Designation  Associate Professor and Head 
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202923102  
Fax    
Email  krithica.s@manipal.edu  
 
Source of Monetary or Material Support  
Director, Manipal Institute of Technology, Eshwar Nagar, Manipal, Udupi, Karnataka-576104 
 
Primary Sponsor  
Name  Vishwas G Kini 
Address  Manipal Institute of Technology(MIT), Eshwar Nagar, Manipal, Udupi, Karnataka-576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Head of the Department Department of Optometry  Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krithica S  Manipal College of Health Professions  Optometry Clinic CTC and Wellness Clinic, Department of optometry, Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 8861330980

krithica.s@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1)Corrected-to-normal or normal visual acuity participants & 2)Normal or near-normal visual fields participants with healthy eyes and no ocular conditions indirectly affect VisualAcuity&VisualField 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) People above 18-65 (College staff and students)
years can participate with corrected-to-normal visual acuity or normal visual acuity participants with healthy eyes and no known ocular conditions that could indirectly affect visual acuity. People may or may not have prior VR experiences.
2) People (College staff and students) above 18-65 years can participate with normal or near-normal
visual fields participants with healthy eyes and no known ocular conditions that could indirectly affect visual field.
People may or may not have prior VR experiences 
 
ExclusionCriteria 
Details  Exclude individuals with ocular disorders
indirectly affecting visual field, visual acuity. People with eye surgeries and injuries are excluded. People with Cognitive impairments, motion sickness, neurological disorders are also excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determination of the visual function values of the participants through VR and conventional tests  VR and non VR testing will be done for about 20 mins for each participant only once in the duration of the trial 
 
Secondary Outcome  
Outcome  TimePoints 
Determination of the motivation, presence of the participants through VR and usability of the testing application  VR and non VR testing will be done for about 20 mins for each participant only once in the duration of the trial 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   16/02/2024 
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="9"
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   Eye related disorders are increasing rapidly in the recent times and it is difficult for the patients to visit the clinic frequently for regular testing and reach out to the clinician in person especially during pandemic times. Hence, there is a need in developing a home-based Visual function assessment test for the patients and motivate for frequent testing for the progression of their visual disorder. This study outcome would enable the patients to test their Visual functions, Visual Acuity and Visual Field using Virtual Reality through gamification to induce motivation to play more and get tested frequently through attention and enjoyment. Considering the adult population, we design home based portable gamified eye tests in VR in order to extend it as an alternative to conventional testing at clinics with possible similar accuracy. Gamification may also enhance motivation and attention in adults; increasing the test accuracy as per the literature discussed. Hence, we test the population between 18-65 years.

Detailed description of procedure / processes: The study (minimal risk) will recruit 34 healthy vision participants with corrected-to-normal visual acuity or normal visual acuity and normal or near to normal visual fields with healthy eyes from the Dept. of Optometry at MCHP & MIT, Manipal and are pre-screened (by asking) for past eye, neurological disorders that would affect Visual function and are excluded. The participants are voluntarily recruited based on their interests by approaching them individually in the institute. The participants are then subjected to the gamified and non-gamified test (approx. 20 mins) versions in VR using Quest 2 and are instructed how to use and wear it. The results are noted down to test the accuracy obtained for visual function and later the participants are asked to describe their experience and rate the questionnaires. The participants are required to visit the clinic only once and no subsequent visits are needed. Principal Investigator along with the help of faculty from Dept. of Optometry will be carrying out the screening. The correlation is made to compare VR test accuracy with the gold standards and questionnaires ratings will be given to understand gamification effects.

Outcome measures: The research proposes a gamified visual function test in Virtual Reality. As an outcome of the study, the visual function testing can be taken at the comfort of the patient’s home through VR headset. Gamification would make the visual function testing enjoyable who lacks attention and motivation. Through frequent testing patients and clinicians will understand the progression of visual function which is difficult to realize in the initial stage.
 
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