EFFECT OF ATROPINE EYE DROPS 0.05% V/S 0.01% ON MYOPIA PROGRESSION IN INDIAN CHILDREN: A RANDOMISED, DOUBLE BLIND, CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5 to 14 years at the time of enrollment.
- •Baseline cycloplegic SER between minus 1.00 D and minus 6.00 D in each eye.
- •Astigmatism (cylindrical) less than or equal to minus 2.5 D.
- •Best-corrected visual acuity 6 by 9 or better in both eyes.
- •Child and parent or guardian willing to give consent and comply with follow up and treatment.
排除标准
- •Prior use of atropine or other myopia control treatments (orthokeratology, multifocal lenses, etc.) in the past 12 months.
- •Ocular diseases other than simple refractive error (e.g., amblyopia, strabismus, glaucoma, uveitis, retinal disease etc).
- •History of ocular surgery, trauma, or systemic/ocular medications affecting refraction.
- •Known allergy or hypersensitivity to atropine or formulation ingredients.
- •Inability of child or parent to adhere to study schedule or follow-up.
研究者
Dr Monika Meena
All India institute of medical sciences, gorakhpur