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CTRI Number  CTRI/2023/12/060537 [Registered on: 19/12/2023] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Special Spectcales]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment to prevent the increase in myopia among children 
Scientific Title of Study   Evaluating Interventional Modalities to prevent progression of childhood myopia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Gupta 
Designation  Senior Research Fellow, PhD Scholar 
Affiliation  AIIMS New Delhi 
Address  8/55, AIIMS BOYS HOSTEL, AIIMS NEW DELHI
AIIMS, Ansari Nagar East, New Delhi
South
DELHI
110029
India 
Phone  8126404472  
Fax    
Email  vinay.dhruv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rohit Saxena 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  377, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS NEW DELHI
AIIMS, Ansari Nagar East, New Delhi
South
DELHI
110029
India 
Phone    
Fax    
Email  rohitsaxena80@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vinay Gupta 
Designation  Senior Research Fellow, PhD Scholar 
Affiliation  AIIMS New Delhi 
Address  8/55, AIIMS BOYS HOSTEL, AIIMS NEW DELHI
AIIMS, Ansari Nagar East, New Delhi

DELHI
110029
India 
Phone  8126404472  
Fax    
Email  vinay.dhruv@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  135, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS New Delhi 
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 
Dr Vinay Gupta  AIIMS New Delhi  135, Neuro-ophthalmology lab Dr. R. P. Centre, AIIMS New Delhi 110029
South
DELHI 		 8126404472

vinay.dhruv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atropine 0.01% eye drops  Atropine sulphate 0.01% ophthalmic solution once at night in both eyes for 2 years 
Intervention  Atropine 0.05% eye drops  Atropine sulphate 0.05% ophthalmic solution once at night in both eyes for 2 year 
Intervention  Defocus Induced Multiple Segment Spectacles  Defocus Induced Multiple Segment Spectacles for full time wear for 2 years 
Intervention  Increased outdoor activity  Increased outdoor activity by 120 minutes per day for 1 year 
Intervention  Multifocal Contact lens  Multifocal contact lens for daytime wear for 1 year 
Comparator Agent  NO comparator agent  NIL 
Intervention  Orthokeratology  Ortho-K lenses for overnight wear for 1 year 
Intervention  Spectacles with Highly Aspherical lenslets (high add)  Spectacles with Highly Aspherical lenslets (high add) for full time wear for 2 years 
Intervention  Spectacles with Highly Aspherical lenslets (Low add)  Spectacles with Highly Aspherical lenslets (Low add) for full time wear for 2 years 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  5-15 year children with documented myopia progression of ≥0.5D/year, myopic refractive error -1 D to -6 D, Best corrected visual acuity 6/9 or better in both the eyes. 
 
ExclusionCriteria 
Details  Previously on myopia control intervention, history of ocular surgery, anisometropia (> 1D), high astigmatism (> -1.5D), children with strabismus, amblyopia, ocular pathology including poor ocular surface, corneal opacities, staphyloma etc., high astigmatism (> -1.5D), not willing to follow-up/giving consent 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Spherical Equivalent Refractive error  Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in ocular biometric parameters (axial length, keratometry, Lens power)  Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month. 
Change in amplitude of accommodation  Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month. 
Change in pupil size  Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month. 
Effect on higher order aberrations, retinal image quality and contrast sensitivity  Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/12/2023 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - NO
Brief Summary  

This study hypothesizes that different interventional modalities will showcase varying efficacies in halting the progression of childhood myopia. The response to myopia control interventions can be influenced by multiple factors including age, gender, the severity of the baseline myopia, the presence of parental myopia, and patient compliance to the treatment. Additionally, myopia control strategies might have discernible effects on higher-order aberrations, retinal image quality, and contrast sensitivity at increased spatial frequencies in children diagnosed with myopia. An intriguing correlation is postulated between the progression rate of myopia and alterations in the parapapillary zones, suggesting these zones as promising biomarkers for tracking myopia advancement.

The primary aim of this study is to assess the efficacy of various interventional modalities in preventing the progression of childhood myopia. Concurrently, the research seeks to identify the specific factors that influence the response to these treatments. A significant part of the investigation will also focus on discerning the impacts of both myopia and its control interventions on parameters such as higher-order aberrations, retinal image quality, and contrast sensitivity at increased spatial frequencies.


 
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