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CTRI Number  CTRI/2026/03/106684 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 21/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study in Indian Children to Compare Two Atropine Eye Drops for Slowing Nearsightedness (Myopia) 
Scientific Title of Study   EFFECT OF ATROPINE EYE DROPS 0.05% V/S 0.01% ON MYOPIA PROGRESSION IN INDIAN CHILDREN: A RANDOMISED, DOUBLE BLIND, CONTROLLED TRIAL 
Trial Acronym  AIM trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monika Meena  
Designation  Junior Resident  
Affiliation  All India institute of medical sciences, gorakhpur  
Address  Dept. Of Ophthalmology, OPD block ,1st floor, All india institute of medical sciences, gorakhpur , kunraghat

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  6356110941  
Fax    
Email  drmonikameena635@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Richa Agarwal  
Designation  Associate professor  
Affiliation  All india institue of medical sciences 
Address  Dept. Of Ophthalmology, OPD block , 1st floor, All india institute of medical sciences, gorakhpur , kunraghat

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9891177120  
Fax    
Email  richaagarwal101@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Richa Agarwal  
Designation  Associate professor  
Affiliation  All india institue of medical sciences 
Address  Dept. Of Ophthalmology, OPD block ,1st floor, All india institute of medical sciences, gorakhpur , kunraghat

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9891177120  
Fax    
Email  richaagarwal101@gmail.com   
 
Source of Monetary or Material Support  
All india institute of medical sciences, Gorakhpur  
 
Primary Sponsor  
Name  Dr monika meena 
Address  Dept. Of ophthalmology, opd block, 1st floor, AIIMS GORAKHPUR, kunraghat, UP, India 273008 
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 Monika Meena  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, GORAKHPUR  Department of Ophthalmology OPD, AIIMS GORAKHPUR , KUNRAGHAT, GORAKHPUR , UP, 273008
Gorakhpur
UTTAR PRADESH 
6356110941

drmonikameena635@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur  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 
Comparator Agent  Atropine 0.01%   Atropine ophthalmic solution 0.01% one drop instilled in each eye once nightly for myopia control, continued for 12 months 
Intervention  Atropine 0.05%   Atropine ophthalmic solution 0.05% one drop instilled in each eye once nightly for myopia control, continued for 12 months  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children aged 5 to 14 years at the time of enrollment.
2. Baseline cycloplegic SER between minus 1.00 D and minus 6.00 D in each eye.
3. Astigmatism (cylindrical) less than or equal to minus 2.5 D.
4. Best-corrected visual acuity 6 by 9 or better in both eyes.
5. Child and parent or guardian willing to give consent and comply with follow up and treatment. 
 
ExclusionCriteria 
Details  1. Prior use of atropine or other myopia control treatments (orthokeratology, multifocal lenses,
etc.) in the past 12 months.
2. Ocular diseases other than simple refractive error (e.g., amblyopia, strabismus, glaucoma,
uveitis, retinal disease etc).
3. History of ocular surgery, trauma, or systemic/ocular medications affecting refraction.
4. Known allergy or hypersensitivity to atropine or formulation ingredients.
5. Systemic or neurological conditions interfering with compliance or accurate testing.
6. Inability of child or parent to adhere to study schedule or follow-up. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The mean change in spherical equivalent refraction (SER) from baseline to 12 months
between children treated with 0.05% atropine and those treated with 0.01% atropine.
 
At baseline,1 month,6 month and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
1.The change in axial length (mm) from baseline to 12 months between the two groups.
2.The changes in accommodative amplitude induced by the two concentrations.
3.The incidence and severity of adverse effects (photophobia, near vision blur, allergic
reactions, etc.) between 0.05% and 0.01% atropine groups.
4. To explore potential predictors of response.
 
At baseline,1 month,6 month and 12 months  
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/04/2026 
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 - NO
Brief Summary   Myopia or nearsightedness is one of the most common refractive errors in children and has 
become a major global public health concern. Its prevalence has increased markedly in recent 
decades, especially in Asian countries, including India. The global burden of myopia is expected 
to reach epidemic levels, with projections estimating that half of the world’s population will be 
myopic by 2050. Early-onset myopia often progresses during childhood and increases the risk of 
high myopia in adulthood. High myopia is associated with complications such as retinal 
detachment, glaucoma, and myopic maculopathy d/t excessive axial length elongation, which 
can cause permanent visual impairment. 
Atropine eye drops are widely recognized as an effective intervention for slowing myopia 
progression. Mainly Low-dose atropine is now widely used to slow myopia progression, but its 
optimal concentration varies. Earlier, high concentrations such as 1% atropine were shown to be 
highly effective in reducing myopia progression, but they caused significant side effects 
including photophobia and near blur, as demonstrated in the ATOM1 ( Atropine for the 
Treatment of Childhood Myopia) study. To address these concerns, the ATOM2 study 
compared 0.5%, 0.1% and 0.01% atropine, and found that while all concentrations were 
effective, 0.01% had the least side effects, although it was less effective in controlling axial 
elongation. More recently, the LAMP (Low-Concentration Atropine for Myopia Progression) 
study reported that 0.05% atropine provided better control of myopia progression and axial 
length growth compared to 0.01%, while still maintaining acceptable tolerability. These 
findings suggest that 0.05% and 0.01% represent two clinically useful concentrations, and 
comparing their effectiveness in different populations, such as Indian children, is necessary to 
select the most suitable dosage for routine clinical use.
Although low-dose atropine therapy is used for myopia management, region-specific evidence in 
North Indian pediatric populations is limited. Environmental and lifestyle factors such as 
outdoor activity, near-work duration, and screen exposure vary across different regions and may 
influence treatment outcomes.
Hence by comparing 0.05% and 0.01% atropine, this study aims to assess which concentration 
provides better control of myopia progression (refractive and axial length changes) with acceptable tolerance in the local population. The findings may help develop region-appropriate 
myopia management recommendations for Indian children.
 
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