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A Longitudinal Study Evaluating the Impact of 0.01% Atropine in High Myopic Children (RAMCOM-II Study)
Pradeep Agarwal1, Veenu Maan1, Ashi Khurana2
1Department of Pediatric Ophthalmology, Strabismus and Neuro-Ophthalmology, CL Gupta Eye Institute, Moradabad, Uttar Pradesh, India.
Insights
Low-dose atropine eye drops (0.01%) effectively slowed myopia progression in children over five years. This treatment demonstrated sustained efficacy in managing pediatric high myopia, showing significant reductions in refractive error compared to controls.
Area of Science:
- Ophthalmology
- Pediatric Medicine
- Clinical Research
Background:
- High myopia in children poses significant risks for serious ocular conditions later in life.
- Effective myopia control strategies are crucial for preventing long-term vision impairment in pediatric populations.
- The RAMCOM-II study builds upon previous research to evaluate extended low-dose atropine treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of 0.01% atropine eye drops administered over four years in children with high myopia.
- To assess the long-term impact of atropine treatment following a one-year observation period.
Main Methods:
- An interventional, non-randomized study design (RAMCOM-II) involving a one-year baseline observation.
- Two groups: intervention (0.01% atropine daily) and control (no treatment).
- Annual assessments of myopia progression, axial elongation, visual acuity, adverse events, and compliance.
Main Results:
- At 4 years, atropine significantly reduced myopia progression (2.0 D vs. 3.2 D, P=0.01) and axial elongation compared to controls.
- Sustained efficacy observed at 5 years, with continued significant reduction in myopia progression (2.2 D vs. 3.4 D, P=0.01).
- Long-term benefits of 0.01% atropine in managing pediatric high myopia were highlighted.
Conclusions:
- The RAMCOM-II study confirms the efficacy of 0.01% atropine in controlling myopia progression over a five-year period.
- 0.01% atropine presents a promising therapeutic option for managing high myopia in children.
- Sustained use of low-dose atropine is effective for long-term myopia management in pediatric patients.
Purpose:
To assess the safety and efficacy of the 4-year administration of 0.01% atropine following a 1-year observation period in high myopic children.
Methods:
The RAMCOM-II study continues the RAMCOM study, designed as an interventional nonrandomized study. Participants were observed for 1 year without any intervention to establish a baseline. Subsequently, children were divided into two arms: participants in the intervention group received one drop of 0.01% atropine daily at bedtime from years 1 to 5, while the control arm received no treatment and was monitored with routine clinical examinations. Annual assessments captured myopia progression, visual acuity, adverse events, and compliance. Statistical analyses compared outcomes between the two groups, considering demographic factors.
Results:
At the 4-year follow-up, myopia progression from baseline in the intervention group (atropine-treated eyes) was significantly lower than in the control group (2.0 ± 2.0 diopter [D] vs. 3.2 ± 1.9 D, P = 0.01). Axial elongation also favored the intervention group. At the 5-year follow-up, similar trends persisted, underscoring the sustained efficacy of 0.01% atropine. Myopia progression remained significantly reduced in the intervention group compared to the control group (2.2 ± 2.0 D vs. 3.4 ± 1.9 D, P = 0.01). Although differences in axial elongation were less pronounced, these findings highlight the long-term benefits of 0.01% atropine in managing high myopia in children.
Conclusion:
The RAMCOM-II study supports the efficacy of 0.01% atropine in controlling myopia progression over 5 years, emphasizing its promising role in pediatric high myopia management.
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