Correspondence
REPLY: We thank Dr Venkatesh for his interest in our study. The
I-ATOM study was a multicentric, double-blinded, placebo-
controlled clinical trial.1 All myopic children with a range of
myopia from e0.50 to
e6 diopter sphere (DS) were screened.
A documented increase of  0.5 DS of myopia during the
preceding year was used to define children with progression for
the purpose of the study. Using the study’s inclusion criteria, it is
possible that a child who has þ0.25 D hyperopia in the
previous year and progresses to develop e0.5 D myopia could
have been eligible for inclusion in this study. However, the
minimum refractive error at the time of enrolment in either of the
groups in this study was e1.00 D.
Both eyes were treated with low-dose atropine (0.01%) and
clustered data from both eyes of the same patient was pooled using
robust standard error.2
The sample size was based on a previous study that noted a

60% decrease in myopia progression in a Chinese population with
atropine 0.01% in 1 year.3 Because atropine 0.01% may be
differentially effective in an Indian population, an appropriate
estimate of effect size was done. To detect a  40% difference in
myopia progression using within-group standard deviation of 0.5
D and 1:1 randomization, a sample size of 84 participants (42
participants per arm) was required to achieve 90% power with a
2-sided test of 5% (0.05 significance level). Considering the
attrition rate of 15%, a total sample size of 100 participants (50
participants per arm) was required.
Refraction was carried out by a single optometrist in every
center. Automated refraction was done under homatropine 2%
instilled thrice at a 10-minute interval followed by subjective
acceptance. Three readings using an automated refractometer were
taken and the median was recorded. The final power was prescribed
based on subjective acceptance and was recorded for analysis.
Because changes in spherical equivalent are nearly constant over
time in the atropine group, the effect of significant change in
myopia progression is possibly related to the cumulative effect of
0.01% atropine (Fig S1 in the original article1). We analyzed the
spherical equivalent change in 3 different quadrimesters (4-month
Table 1. Mean Change in Spherical Equivalent Between Different
Time Period in 2 Study Groups
Mean D Spherical Equivalent Baseline to 4 4e8 8e12 P correlated data. Biometrics. 2000;56:645e646.
(in Diopters) months months months value
Atropine treatment group 0.04 0.07 0.03 0.09
Placebo control group 0.15 0.13 0.16 0.14
periods) in the 2 groups. Change in the spherical equivalent
between different time periods (from baseline to 4 months, 4e8
months, and 8e12 months) in the atropine treatment group was
evaluated and was not found to be significant (P ¼ 0.09) (Table 1).
We agree with the author that atropine could increase the pupil
size, but a small change is difficult to appreciate clinically. In our
study, we found statistically insignificant changes in pupil size with
0.01% atropine. Such clinically insignificant change on follow-up
in the pupil size from baseline did not result in the unmasking of
therapy to the blinded observer in this study.
This study evaluated the effect of 0.01% atropine versus placebo
at 1 year. After completion of the study period and as per the study
protocol, all patients were shifted to open-label 0.01% atropine
drops.
ROHIT SAXENA, MD, PHD
VINAY GUPTA, MS
REBIKA DHIMAN, MD
SWATI PHULJHELE, MD
NAMRATA SHARMA, MD
Paediatric Ophthalmology and Strabismus Services, Dr. R. P. Centre for
Ophthalmic Sciences, AIIMS, New Delhi, India
Disclosure(s):
All authors have completed and submitted the ICMJE disclosures form.
The authors have no proprietary or commercial interest in any materials
discussed in this article.
Available online: ---.
Correspondence:
Rohit Saxena, MD, PhD, Neuro-ophthalmology and Strabismus Ser-
vices, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of
Medical Sciences, Ansari Nagar, New Delhi, India. E-mail:
rohitsaxena80@yahoo.com.
References
1. Saxena R, Dhiman R, Gupta V, et al. Atropine for the treatment
of childhood myopia in India: Multicentric randomized trial.
Ophthalmology. 2021;128:1367e1369.
2. Williams RL. A note on robust variance estimation for cluster
3. Chia A, Chua W-H, Cheung Y-B, et al. Atropine for the treat-
ment of childhood myopia: safety and efficacy of 0.5%, 0.1%
and 0.01% doses (Atropine for the Treatment of Myopia 2).
Ophthalmology. 2012;119:347e354.
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