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CTRI Number  CTRI/2025/03/081823 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Eye Test Software to Measure Suppression size and depth in Lazy Eye 
Scientific Title of Study   Development of a stand-alone software tool for quantitative measurement of suppression size and depth in amblyopia and its association with visual acuity and stereoacuity in Anisometropic Amblyopia 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srividhya L 
Designation  Assistant Professor 
Affiliation  M S Ramaiah University of Applied Sciences 
Address  Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India 
Phone  9632027883  
Fax    
Email  srividhya.ah.ls@msruas.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Srividhya L 
Designation  Assistant Professor 
Affiliation  M S Ramaiah University of Applied Sciences 
Address  Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road,
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India 
Phone  9632027883  
Fax    
Email  srividhya.ah.ls@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Srividhya L 
Designation  Assistant Professor 
Affiliation  M S Ramaiah University of Applied Sciences 
Address  Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India 
Phone  9632027883  
Fax    
Email  srividhya.ah.ls@msruas.ac.in  
 
Source of Monetary or Material Support  
Department of Ophthalmology, Ramaiah Medical College Hospital, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bangalore - 560054  
 
Primary Sponsor  
Name  Srividhya L 
Address  Assistant Professor, Room 4, Division of Optometry, Department of Allied Health Sciences, Faculty of Life and Allied Health Sciences, M S Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bengaluru 560054 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NA  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananth S Bhandary  M S RAMAIAH MEDICAL COLLEGE HOSPITAL  Department of Ophthalmology, Optometry Division, Room 3, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA 
9845832789

ananthbhandary.rmc@msruas.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The University Ethics Committee for Human trials of M S Ramaiah University of Applied Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H530||Amblyopia ex anopsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients diagnosed with amblyopia aged between 10 to 40 years and cooperative in the assessments of interocular suppression. 
 
ExclusionCriteria 
Details  Amblyopic patients with strabismus associated with ocular albinism, diplopia, or a medical
history of seizures are excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quantification of suppression size and depth in amblyopia using a newly developed clinical tool, measured in terms of the visual angle (degrees) over which suppression occurs and the contrast difference required to overcome suppression  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the association of suppression size (in terms of visual angle) and suppression depth (in terms of difference in contrast between amblyopic eye and fellow fixing eye) and visual acuity in individuals with aniso myopic and aniso hypermetropic amblyopia  10 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/03/2025 
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="1"
Months="10"
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  
Amblyopia is a neurodevelopmental abnormality that results in impaired visual acuity as well as stereopsis, and contrast sensitivity in one eye or in both due to physiological alterations in the visual pathways. Amblyopia could be clinically classified based on etiology as strabismic(misalignment of the eyes) amblyopia, anisometropic amblyopia (clinically significant difference of about 2 dioptre between the eyes) and mixed amblyopia (presence of both strabismus and anisometropia). Interocular Suppression plays a key role in visual deficit in Amblyopia. Amblyopic Suppression in relation to binocular vision refers to an inhibitory effect of the fellow eye over the amblyopic eye when both eyes are viewing. The characteristics of suppression in different types of amblyopia and the association of the suppression size and depth with the visual acuity loss and stereoacuity loss in amblyopia is not well understood. 
The currently available clinical tests for quantifying suppression are binary (presence or absence of suppression), rudimentary, and have limitations of test-retest reliability. While current amblyopia management focuses on visual acuity and stereoacuity improvements, changes in suppression are not systematically quantified. The interplay between visual acuity enhancement through amblyopia treatment and alterations in suppression size or depth remains inadequately explored. This advocates the need to develop a clinical tool to quantify suppression size and depth in clinical practice. Quantifying the suppression size and depth in amblyopia needs to be established in clinical practice and also it could provide insights into the changes in characteristics of suppression during amblyopia treatment. This could be further researched to get an effective monitoring of different management plans for amblyopia like patching, binocular therapies and anti-suppression therapy. 
Quantifying suppression size and depth would also provide a method to rank the amblyopes with nil stereo acuity. Thus a tool for the clinical quantification of suppression size and depth in amblyopia needs to be developed and validated. This research aims to fill this gap by developing a clinically viable tool for quantifying suppression size and depth in amblyopia. The proposed study seeks to establish the clinical utility of quantifying suppression characteristics, offering insights into dynamic changes during amblyopia treatment. This research could potentially pave the way for more effective monitoring and tailored management strategies for different amblyopic subtypes. Moreover, the exploration of suppression size and depth in association with visual acuity and stereoacuity loss in anisometropic amblyopia, specifically aniso-myopic and aniso-hypermetropic amblyopia, adds a novel dimension to this study.

 
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