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CTRI Number  CTRI/2018/08/015346 [Registered on: 16/08/2018] Trial Registered Retrospectively
Last Modified On: 03/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Behavioral
Other (Specify) [vision therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare outcome of binocular video game play versus patching of the good eye in children with amblyopia 
Scientific Title of Study   Comparative study of binocular visual stimulation versus monocular occlusion therapy in children with amblyopia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Saxena 
Designation  Additional Professor of ophthalmology 
Affiliation  All India Institute of Medical Sciences 
Address  Room 377 Third Floor RP Centre AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India

South West
DELHI
110029
India 
Phone  01126593182  
Fax  01126593182  
Email  rohitsaxena80@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohit Saxena 
Designation  Additional Professor of ophthalmology 
Affiliation  All India Institute of Medical Sciences 
Address  Room 377 Third Floor RP Centre AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India

South West
DELHI
110029
India 
Phone  01126593182  
Fax  01126593182  
Email  rohitsaxena80@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Shayeri Roy 
Designation  junior resident, RPC, AIIMS 
Affiliation  All India Institute of Medical Sciences 
Address  Room 377 Third Floor RP Centre AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India

South West
DELHI
110029
India 
Phone  01126593182  
Fax  01126593182  
Email  roy.shayeri18@gmail.com  
 
Source of Monetary or Material Support  
Dr Rohit Saxena Room 377 Third Floor RP Centre AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India 
 
Primary Sponsor  
Name  Dr Rajendra Prasad Centre for Ophthalmic Sciences 
Address  RP Centre, AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India  
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 
Dr Rohit Saxena  Dr Rajendra Prasad Centre for Ophthalmic Sciences  Room 377 Third Floor RP Centre AIIMS Aurobindo marg, Ansari nagar New Delhi DELHI 110029 India
South West
DELHI 
01126593182
01126593182
rohitsaxena80@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics comittee,All India Institute of medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Anisometropic amblyopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Binocular visual stimulation  Binocular visual stimulation using binocular tetris video game which is to be played on smartphones or tablets wearing red green glasses 
Comparator Agent  Monocular occlusion therapy  Part time patching of better eye 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Age group: 7-15 years
Anisometropic amblyopia
Unilateral cases
Visual acuity 6/12-6/60 in amblyopic eye
No manifest squint
Ready availability of a computer/tablet/smartphone at home or nearby for daily access
Willingness and ability to play the game demonstrated by scoring at least one completed line
Children whose parents/guardians give appropriate consent  
 
ExclusionCriteria 
Details  Corneal opacities, cataract, ptosis
Nystagmus
Manifest squint
Previous history of treatment of amblyopia
Patients with other ocular pathologies ( e.g., involving the macula)
Myopia of >6D
History of seizure disorder  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
visual outcome in terms of best corrected visual acuity, near vision, contrast sensitivity and stereoacuity after intervention  Day 1, 1 month, 2 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
near vision, contrast sensitivity and stereoacuity after intervention  Day 1, 1 month, 2 and 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2017 
Date of Study Completion (India) 03/09/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Amblyopia is defined as a decrease in visual acuity in one eye caused by abnormal binocular interaction or occurring in one or both eyes as a result of patterned vision deprivation during visual immaturity, for which no cause can be detected during physical examination of the eye and which in appropriate cases is reversible by therapeutic measures. Most common cause of monocular amblyopia is anisometropia, i.e., difference of refractive error between both eyes.

  Currently the therapy for amblyopia includes passive monocular approaches like occlusion of the better eye full time or part time (6 hours or 2 hours daily) or pharmacological penalisation using a cyclopagic agent such as atropine, so that the amblyopic eye receives more stimulation and visual acuity improves.

 Recently a binocular approach for treatment of amblyopia has been reported. here both the eyes are presented with a different stimulus i.e., dichoptic stimuli. contrast level is kept higher in the amblyopic eye to give it advantage over the good eye and thus to overcome suppression, while encouraging simultaneous use of both the eyes. Multiple ipad, ipod, smartphone and computer video games has been devised based on this principle. One such game is dichoptic version of tetris or falling blocks game which has to be played wearing red green anaglyph glasses. the fallingblocks are seen by one eye and  the landed blocks are seen by the other eye. contrast can be adjusted as per the need. 

 The main aim of this study is to compare the final visual outcome in the amblyopic eye in terms of best corrected visual acuity between two group of patients having anisometropic amblyopia, one group playing binocular tetris video game for 2 hours daily, 7 days a week for 3 months and the second group using patching over the amblyopic eye for 6 hours a day, 7 days a week for three months.

 
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