| 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
|
|
|
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
|
|
|
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. |