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CTRI Number  CTRI/2022/12/048149 [Registered on: 15/12/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Construction and Validation of a new visual acuity chart which helps to find suppression of the eye by the brain in Lazy eye disease in school children  
Scientific Title of Study   Construction and Validation of Anaglyph dichoptic vision chart and its application in detecting suppression in paediatric eye screening.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaushik Murali 
Designation  Senior consultant and head, Pediatric ophthalmology  
Affiliation  Sankara eye hospital 
Address  Sankara eye hospital Varthur Road Kundalahalli gate Munnekollal

Bangalore
KARNATAKA
560037
India 
Phone  9739000096  
Fax    
Email  kaushik@sankaraeye.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kaushik Murali 
Designation  Senior consultant and head, Pediatric ophthalmology  
Affiliation  Sankara eye hospital 
Address  Sankara eye hospital Varthur Road Kundalahalli gate Munnekollal

Bangalore
KARNATAKA
560037
India 
Phone  9739000096  
Fax    
Email  kaushik@sankaraeye.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sajal jain 
Designation  Resident (DNB) ophthalmology 
Affiliation  Sankara eye hospital Bangalore 
Address  Sankara eye hospital Varthur Road Kundalahalli gate Munnekollal

Bangalore
KARNATAKA
560037
India 
Phone  7022129459  
Fax    
Email  sajal.jain1806@gmail.com  
 
Source of Monetary or Material Support  
Sankara eye hospital,Bangalore 
 
Primary Sponsor  
Name  Sankara eye hospital Bangalore 
Address  Varthur Road,Kundalahalli gate,munnekollal, Bangalore,karnataka 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kaushik murali  Sankara eye hospital  Department of Pediatric ophthalmology/Myopia clinic/
Bangalore
KARNATAKA 
9739000096

Kaushik@sankaraeye.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee sankara eye hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Suppression 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Verbal Children between 8-15 years of age 
 
ExclusionCriteria 
Details  Non verbal children
Children with developmental delay or low IQ interfering with visual acuity testing 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mono ocular visual acuity interpreted from binocular chart with that recorded using standard ETDRS chart  Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
Size of suppression scotoma  Immediate 
 
Target Sample Size   Total Sample Size="4099"
Sample Size from India="4099" 
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)   20/12/2022 
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="2"
Months="0"
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  

Amblyopia being the most common cause of monocular vision loss in children, is defined as decreased best-corrected visual acuity (VA) in one, or less frequently both eyes, in the absence of any obvious structural anomalies or ocular disease.


The gold standard for amblyopia screening is visual acuity testing and most vision screening programs still rely on visual acuity charts as their primary screening test for amblyopia. Visual acuity testing requires cooperation from the children and needs to be done in each eye separately. It is subject to errors depending on if children have memorized the charts, peeps from other eye while testing, and so on.


Suppression of an eye is a subconscious adaptation by a person’s brain to eliminate double vision by ignoring all or part of the image of one of the eyes, and is an important component of amblyopia. The currently options available commercially for assessing suppression are the Four base out prism test, Worth Four dot test, Polarized four dot test.


Most commercial methods of testing suppression measure only foveal or central suppression at one test distance.Also,current clinical tests for suppression tend to verify the presence or absence of suppression rather than giving a quantitative measurement of the degree of suppression.


In this study, we aim to develop a new chart based on dichoptic principles thus detecting suppression and quantifying it by measuring the size of suppression scotoma,testing mono-ocular visual acuity binocularly and validating it with standard ETDRS chart which is used for screening 
amblyopia in school going children currently. 
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