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CTRI Number  CTRI/2022/01/039810 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 27/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mobile Games]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Mobile Games as a Form of Near Visual Exercise in Adult Amblyopia 
Scientific Title of Study   Role of Mobile Games as a Form of Near Visual Exercise in Adult Amblyopia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rishabh Sah 
Designation  Post Graduate Resident Doctor 
Affiliation  Guru Nanak Eye Center, MAMC 
Address  Room 101, Guru Nanak Eye Center, Maulana Azad Medical College, Maharaja Ranjit Singh Marg, New Delhi

Central
DELHI
110002
India 
Phone  9984774937  
Fax    
Email  sah.rishabh@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Dadeya 
Designation  Director Professor 
Affiliation  Guru Nanak Eye Center, MAMC 
Address  room 114, Guru Nanak Eye Center, Maulana Azad Medical College, Maharaja Ranjit Singh Marg, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  dadeya868@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash Dadeya 
Designation  Director Professor 
Affiliation  Guru Nanak Eye Center, MAMC 
Address  room 114, Guru Nanak Eye Center, Maulana Azad Medical College, Maharaja Ranjit Singh Marg, New Delhi

North West
DELHI
110002
India 
Phone    
Fax    
Email  dadeya868@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Eye Center, Maulana Azad Medical College, Maharaja Ranjit Singh Marg, New Delhi, 110002 
 
Primary Sponsor  
Name  Guru Nanak Eye Center 
Address  Guru Nanak Eye Center, Maulana Azad Medical college, Maharaja Ranjit Singh Marg, New Delhi, 110002 
Type of Sponsor  Government medical college 
 
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 
Rishabh Sah  Guru Nanak Eye Center  room no. 207, Guru Nanak Eye Center, Maulana Azad Medical College, Maharaja Ranjit Singh Marg, New Delhi, 110002
Central
DELHI 		 9984774937

sah.rishabh@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  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  mobile games with occlusion  dichoptic mobile games as a form of near visual exercise practiced for two hours per week in addition to occlusion for 6 hours a day for 6 days a week 
Comparator Agent  occlusion  occlusion of the amblyopic eye for 6 hours a day for 6 days a week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Visual acuity in amblyopic eye between 6/60-6/12; Refractive error corrected with spectacles for atleast 4 weeks; Amblyopia associated with strabismus, anisometropia or both  
 
ExclusionCriteria 
Details  patient with previous surgery; patient recieving any visual therapy or orthoptics currently;presence of ocular cause of reduced visual acuity; known skin reaction to patch or adhesive bnandage 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual acuity at three month follow up in the intervention group versus control group   baseline, 1 week, 2 week, 3 week, 4 week, 5 week,6 week 
 
Secondary Outcome  
Outcome  TimePoints 
stereoacuity at three month follow up in intervention group versus that in control group  three month follow up 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 2 
Date of First Enrollment (India)   02/02/2022 
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="1"
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 which is the unilateral or bilateral diminution of vision caused by form visual deprivation and/or abnormal binocular interaction, is one of the most common causes of preventable blindness in children, young and middle aged adults.traditionally amblyopia was thought  to be treatable only in children but recent studies have shown amblyopia can be treated in adults also. traditional treatment modalities include refractive correction, patching and penalisation. recent trends indicate role of active home vision exercises in the form of dichoptic video games in the treatment of amblyopia.
in our study patients with unilateral amblyopia will be randomly divided into two groups. one of the groups will receive the traditional treatment that is patching whereas the other group will receive two hour weekly sessions of dichoptic mobile game exercises in addition to patching and the improvement in visual acuity and stereoacuity in these groups will be compared.
 
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