FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030724 [Registered on: 22/01/2021] Trial Registered Prospectively
Last Modified On: 22/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Other (Specify) [Smartphone App and Virtual headset to measure IOP,VA& visual field testing]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Glaucoma screening using smartphones 
Scientific Title of Study   To develop, evaluate the clinical usage and diagnostic performance clinieally for smartphone based scalable eyecare applications like IOP measurements, visual acuity & VR Headset based visual field testing for glaucoma screening & progression management." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science 
Address  Department of Ophthalmology All India Institute of Medical Sciences,Basni Industrial area, MIA 2nd Phase,

Jodhpur
RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  bulbul.morya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science 
Address  Department of Ophthalmology All India Institute of Medical Sciences,Basni Industrial area, MIA 2nd Phase,


RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  bulbul.morya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science 
Address  Department of Ophthalmology All India Institute of Medical Sciences,Basni Industrial area, MIA 2nd Phase,


RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  bulbul.morya@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Arvind kumar morya 
Address  Department of Ophthalmology All India Institute of Medical Sciences,Basni Industrial area, MIA 2nd Phase, 342005 
Type of Sponsor  Other [self funded by Dr Arvind kumar morya] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Gupta  RNT Medical College, Udaipur  Room No.3,Dept. of Ophthalmology, RNT Medical College,Court Chowk, Citys Prime Health Care Area, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN 		 941416658

vijaygupta19682@yahoo.com 
Dr Arvind Kumar Morya  All India Institute of Medical Sciences, Jodhpur  Room no.424, Dept. of Ophthalmology, AIIMS, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 9812403786

bulbul.morya@gmail.com 
Dr Lipa Mohanty  Geetanjali Medical College and hospital, Udaipur Udaipur  Room no. 4, Dept. of Ophthalmology, Geetanjali Medical College,Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura, Chouraha, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN 		 9928812280

drlipamohanty@gmail.com 
Dr Rajendra Prasad  RP Eye Institute,New Delhi  Room no 3, Dept. of Ophthalmology,RP Eye Institute,B-1, 1201, Pocket 1, Sector B, Vasant Kunj, New Delhi, Delhi 110070
New Delhi
DELHI 		 9810046823

rpeyeinstitute@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional ethical committee, Jodhpur  Submittted/Under Review 
Institutional Ethics Committee, Geetanjali Medical College Udaipur  Submittted/Under Review 
Institutional Ethics Committee,R P Eye Institute , New Delhi   Submittted/Under Review 
Institutional Ethics Committee,R.N.T Medical College Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H409||Unspecified glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Screening of glaucoma using smart phone based App to measure Intraocular pressure , visual acuity and virtual reality based headset for visual field testing.  Intraocular pressure(IOP), Perimtery(Visual field testing), visual acuity measurement in suitable patients of glaucoma and non -glaucoma using virtual reality based headset and smartphone app.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 20 – 70 years.
2. Patients willing to give written informed consent.
 
 
ExclusionCriteria 
Details  1. Patients who are not unable to understand the procedure.
2. Patients having the retinal pathologies.
3. Patients who have vision BCVA less than 6/60.
4. Patients having contagious communicable disease.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objectives of this study are Virtual Reality based Visual Field Testing and Anterior segment imaging based IntraOcular Pressure (IOP) estimation and Visual Acuity assessment.  OPD Day 1 and OPD Day 3 
 
Secondary Outcome  
Outcome  TimePoints 
a secondary objective is to validate the use of a smartphone based Visual Acuity Test without any ophthalmic apparatus thus paving the way to a prospective tele-ophthalmology application.   18 MONTHS 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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   Phase 4 
Date of First Enrollment (India)   01/02/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The primary objectives of this study are to - VR based VFT and Anterior segment imaging based IntraOcular Pressure (IOP) estimation. The third one, a secondary objective is to validate the use of a smartphone based Visual Acuity Test without any ophthalmic apparatus thus paving the way to a prospective tele-ophthalmology application. VFT tests show good correlation for glaucoma diagnosis but are conducted using heavy and expensive equipment and it being a time-consuming and patient focus oriented test. 

 

 
Close