| CTRI Number |
CTRI/2016/01/006580 [Registered on: 29/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
28/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [active vision therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the role of videogames as a form of active vision therapy in treatment of lazy eye (amblyopia) |
|
Scientific Title of Study
|
Evaluation of the role of videogames as active vision therapy in treatment of amblyopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Sharma |
| Designation |
Professor |
| Affiliation |
Dr. R.P. Centre for Ophthalmic Sciences |
| Address |
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
01126593183 |
| Fax |
|
| Email |
drpsharma57@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archita Singh |
| Designation |
Resident |
| Affiliation |
Dr. R.P. Centre for Ophthalmic Sciences |
| Address |
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
08130560124 |
| Fax |
|
| Email |
architasingh88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Sharma |
| Designation |
Professor |
| Affiliation |
Dr. R.P. Centre for Ophthalmic Sciences |
| Address |
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
Room no.484
Fourth floor
Dr.RP Centre for ophthalmic sciences
AIIMS, Ansari Nagar
DELHI
110029
India |
| Phone |
01126593183 |
| Fax |
|
| Email |
drpsharma57@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
no sponsor |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Pradeep sharma |
Squint clinic, room no.28, RP centre, AIIMS |
RP centre, AIIMS
Ansari Nagar
New Delhi
New Delhi
DELHI |
01126593183
drpsharma57@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 |
| Comparator Agent |
Group 2 |
6 hours of occlusion therapy only |
| Intervention |
Group1 |
videogame therapy along with 6 hours/day of occlusion therapy |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group:6-14 years
2.Anisometropic amblyopia
3.Unilateral cases
4.Visual acuity >6/36 and <6/12
5.No manifest squint
6. Those with access to computers
 |
|
| ExclusionCriteria |
| Details |
1.Corneal opacities,cataract,ptosis
2.Nystagmus
3.Previous h/o treatment taken for amblyopia
4.Other types of amblyopia
5.Patients with other ocular pathologies(eg. Involving the macula)
6.History of seizure disorder
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| best corrected visual acuity |
1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
stereopsis
|
1 month and 3 months |
| contrast senstivity |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: To evaluate the role of monocular videogames as active vision therapy in treatment of amblyopia
Materials and methods: Children between the age group of 6-14 years with anisometropic amblyopia (n=68) with BCVA (Best corrected visual acuity) in the amblyopic eye being >6/36 and <6/12 with no manifest squint were recruited. They were randomly allocated into two groups. One group received 6 hours/day of occlusion therapy (group 1) and the other received 1 hour/day of videogame play for initial one month along with 6 hours/day occlusion therapy (group 2) . Patients were evaluated at baseline, 1 month and 3 months with BCVA, stereoacuity and contrast senstivity.
Results: BCVA improved from 0.61+/-0.12 logMAR at baseline to 0.51+/- 0.14 logMAR at 1 month (p-value=0.001) and 0.40+/- 0.15 logMAR at 3 months (p-value=0.001) in group 1 .In group 2 the BCVA improved from a baseline of 0.65+/-0.09 logMAR to 0.60 +/- 0.10 logMAR at 1 month (p-value=0.001) and 0.48+/-0.10 logMAR (p-value=0.001) at 3 months. With in the younger age group (6-<10 years) improvement in visual acuity was better in group 1 at both time points. In older age group improvement in visual acuity was more in group 1 as compared to group 2 at 1 month.
Conclusion: Videogame play along with occlusion therapy has an advantage in visual recovery in amblyopia. |