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CTRI Number  CTRI/2024/07/071150 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of Occlusion therapy versus orthoptek magnocellular stimulator therapy for amblyopia 
Scientific Title of Study   A Randomised Controlled trial on Orthoptek Magnocellular Stimulator versus Occlusion for Amblyopia for the age group of 6 to 19 years, 20 to 40 years and 40 years or more age group 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ARVIND KUMAR MORYA 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: OG 19, Ophthalmology HOD office, Department of Ophthalmology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana

Nalgonda
TELANGANA
508126
India 
Phone  8003996598  
Fax    
Email  bulbul.morya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ARVIND KUMAR MORYA 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: OG 19, Ophthalmology HOD office, Department of Ophthalmology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana


TELANGANA
508126
India 
Phone  8003996598  
Fax    
Email  bulbul.morya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ARVIND KUMAR MORYA 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no: OG 19, Ophthalmology HOD office, Department of Ophthalmology, All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana


TELANGANA
508126
India 
Phone  8003996598  
Fax    
Email  bulbul.morya@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Bibinagar, Bhuvanagiri District, Telangana, INDIA, 508126 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Bibinagar, Telangana, 508126 
Type of Sponsor  Other [Government autonomous body] 
 
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 Arvind Kumar Morya  All India Institute of Medical Sciences  Room no: OG 19, Department of Ophthalmology All India Institute of Medical Sciences, Bibinagar, Hyderabad
Nalgonda
TELANGANA 		 8003996598

bulbul.morya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (AIIMS, Bibinagar  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 
Comparator Agent  Occlusion therapy  Occlusion will be given for 4-6 hours every 5 days per week for 3 months preferably when they are at home and on leave from school, college and office. 
Intervention  Orthoptek Magnocellular stimulator therapy  The patient will sit at a 1 meter distance from the screen and do exercise of following red and green lights , that flashes at an interval of 150msec, from the Amblyopic eye for 20 mins, both eyes open 5-7 mins and 5 mins from the normal eye. After a break / rest of 1 hour patient will asked to count flashing lights for 200-300 times. Patient will do all these activities under supervision. and in 1hour -1 therapy will be over. The Orthoptek therapy will be given on alternate days for the first 2 Weeks – 6 Sittings in first 15 days followed by once biweekly for 4 sittings and once monthly therapy for 2 sittings if needed for maintenance.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients of refractive and strabismic amblyopia visiting our OPD with clear cornea, strabismus, no lenticular opacities, no retinal or optic nerve pathologies, no mechanical lid cause leading to amblyopia.
After proper screening and consent patients of refractive and strabismic amblyopia will be randomized on 4- Block basis with, Mild Amblyopia – 30-40%, Moderate Amblyopia 30-40% and Severe Amblyopia – 20%.
After randomization in the Orthoptek group – The patient will sit at a 1 meter distance from the screen and do exercise of following red and green lights , that flashes at an interval of 150msec, from the Amblyopic eye for 20 mins, both eyes open 5-7 mins and 5 mins from the normal eye. After a break / rest of 1 hour patient will asked to count flashing lights for 200-300 times. Patient will do all these activities under supervision of an Optometrist / Resident. So, in 1hour -1 therapy will be over.
The Orthoptek therapy will be given on alternate days for the first 2 Weeks – 6 Sittings in first 15 days followed by once biweekly for 4 sittings and once monthly therapy for 2 sittings if needed for maintenance.
In the conventional Occlusion group – Occlusion will be given for 4-6 hours every 5 days per week for 3 months preferably when they are at home and on leave from school, college and office. The non-improving patients at last follow – up of 6 months will be managed with other modalities of Amblyopia management.
 
 
ExclusionCriteria 
Details  Patients with any pathological ocular disorders and epilepsy will not be considered 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To check if any improvement in the best corrected visual acuity, stereopsis and contrast sensitivity.  18months 
 
Secondary Outcome  
Outcome  TimePoints 
to look for any recurrence and if improvement in the visual acuity, stereopsis and contrast sensitivity following treatment is maintained or not in the subsequent followup.  1 month and 6 months following treatment. 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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 4 
Date of First Enrollment (India)   10/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bulbul.morya@gmail.com].

  6. For how long will this data be available start date provided 10-08-2024 and end date provided 10-08-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Amblyopia is a neurodevelopment disorder caused by abnormal binocular interaction during the critical period of visual development, that impacts vision reduction, contrast sensitivity, or even loss of stereoscopic vision. It is the leading cause of decreased vision among children that generally develops from birth up to age 7 years. Amblyopia is classified as refractive, strabismus, and visual deprivation.

Treatment modalities for amblyopia include occlusion, atropine penalisation, occlutab, bynocs and Orthoptek Magnocellular Stimulator. Occlusion is one of the treatment that is found to be effective since ages. Orthoptek Magnocellular Stimulator aims to exercise parts of the amblyopic patients brain by stimulating the parvocellular and magnocellular pathways that is found to improve visual acuity along with stereopsis and contrast sensitivity. Patients will be randomly recruited and occlusion therapy and orthoptek therapy is given and both are compared interms of visual acuity, contrast sensitivity and stereoacuity and following therapy, if there are any recurrence and the maintenance or deterioration of vision will be noted.

 
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