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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Suppression |
|
Intervention / Comparator Agent
|
|
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. |