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CTRI Number  CTRI/2026/03/105823 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [RCT]  
Study Design  Other 
Public Title of Study   Vision Therapy for Slowing Myopia Progression in Children 
Scientific Title of Study   A Clinical Study Assessing the Efficacy of Vision Therapy in Slowing the Progression of Myopia Rationale 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jamshed ali 
Designation  Phd Scholar 
Affiliation  School of allied health sciences,CT University Ludhiana punjab 
Address  School of allied health sciences, CT University, Ferozepur Ludhiana Road, Sidhwan Khurd, Ludhiana, Punjab 142024

Ludhiana
PUNJAB
142024
India 
Phone  08808222442  
Fax    
Email  alijamshed429@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Nooruz Zaman 
Designation  Associate Professor 
Affiliation  School of allied health sciences,CT University Ludhiana Punjab 
Address  School of allied health sciences, CT University, Ferozepur Ludhiana Road, Sidhwan Khurd, Ludhiana, Punjab 142024

Ludhiana
PUNJAB
142024
India 
Phone  9915501434  
Fax    
Email  mohammadnoor92@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Nooruz Zaman 
Designation  Associate Professor 
Affiliation  School of allied health sciences,CT University Ludhiana Punjab 
Address  School of allied health sciences, CT University, Ferozepur Ludhiana Road, Sidhwan Khurd, Ludhiana, Punjab 142024

Ludhiana
PUNJAB
142024
India 
Phone  9915501434  
Fax    
Email  mohammadnoor92@gmail.com  
 
Source of Monetary or Material Support  
Nill 
 
Primary Sponsor  
Name  Jamshed Ali 
Address  Era university sarfarajganj hardoi road lucknow 226003 
Type of Sponsor  Other [self] 
 
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 Sunil Kumar Gupta  Department of optometry, School Of Allied Health Scinecs, Era University Lucknow   Dr. Sunil Kumar Gupta, Head, Department of optometry, School Of Allied Health Sciences, University building Era University Lucknow Sarfaraz Ganj, Hardoi Road, Lucknow, Uttar Pradesh, India-226003
Lucknow
UTTAR PRADESH 		 7505469470

sunilkumar.gupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tirupati eye center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  good 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group  age : 10-14 years old 2 session per week each session have 30-45 minutes up to 3 months and two follow up after 3 and 6 months Accommodation, convergence and ocular motility 
Intervention  Vision therapy  age : 10-14 years old 2 session per week each session have 30-45 minutes up to 3 months and two follow up after 3 and 6 months Accommodation, convergence and ocular motility 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children and adolescents aged 10-14 years with a diagnosis of progressive myopia (defined as an increase of at least -0.50 diopters in spherical equivalent refraction in the past year).
2. Baseline myopia ranging from -0.50 D to -6.00 D
3. No history of ocular surgery or other significant ocular pathology.
4. Ability and willingness to comply with study protocols, including regular follow-up visits.
 
 
ExclusionCriteria 
Details  1. Previous treatment for myopia progression, such as atropine or orthokeratology, in the past six months.
2. Ocular conditions that could interfere with vision therapy or study outcomes (e.g., strabismus and amblyopia).
3. Any systemic condition that might affect vision or the ability to participate in vision therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Myopia Progression: The primary outcome measure was a change in spherical equivalent refraction (SER) measured using cycloplegic autorefraction.
 		 3-6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Axial Length
Accommodative Function
Binocular Vision Parameters
 		 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   21/03/2026 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [alijamshed429@gmail.com].

  6. For how long will this data be available start date provided 02-06-2026 and end date provided 02-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

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

This study aims to evaluate the efficacy of vision therapy in slowing the progression of myopia among children. Myopia is a growing public health concern, particularly in pediatric populations, with increasing prevalence worldwide. Conventional management strategies primarily involve optical correction; however, vision therapy may offer a non-invasive intervention to reduce the rate of progression.

The trial will recruit children diagnosed with progressive myopia and randomly assign them to either a vision therapy intervention group or a control group receiving standard care. The primary outcome will be the change in spherical equivalent refractive error and axial length over the study period. Secondary outcomes will include improvements in visual function, accommodative response, and quality of life measures.

By systematically assessing clinical outcomes, this study seeks to provide evidence on whether vision therapy can serve as an effective adjunct in myopia management, potentially reducing the burden of high myopia and associated complications in later life.


 
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