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
|
|
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
|
|
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. |