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Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression
Sponsor: Khyber Medical College, Peshawar
Summary
Myopia is one of the fastest-growing ocular disorders worldwide and has become a major public health concern, especially among children and adolescents. Progressive myopia is clinically significant because it increases the lifetime risk of serious ocular complications such as retinal detachment, glaucoma, cataract, and myopic maculopathy. Even a small increase in refractive error has been shown to increase the risk of irreversible visual impairment, highlighting the need for effective strategies to slow myopia progression during childhood. Atropine eye drops have emerged as one of the most effective pharmacological interventions for myopia control. Although high-dose atropine (1%) significantly slows myopia progression, its use is limited by adverse effects such as photophobia, blurred near vision, and poor tolerability. Recent landmark studies, including the Atropine for the Treatment of Myopia (ATOM) and Low-Concentration Atropine for Myopia Progression (LAMP) trials, demonstrated that lower concentrations of atropine (0.01%, 0.03%, and 0.05%) can effectively reduce myopia progression with fewer side effects. However, uncertainty remains regarding the optimal atropine concentration that provides the best balance between efficacy and safety, particularly in South Asian populations where local evidence is limited. This study aims to compare the efficacy and safety of 0.01%, 0.03%, and 0.05% atropine eye drops in controlling myopia progression among children aged 6-18 years in Pakistan. The research question investigates whether these atropine concentrations differ in reducing myopia progression as measured by changes in spherical equivalent refraction (SER) and axial length (AL) over the study period.
Official title: Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2024-06-03
Completion Date
2026-05-22
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Atropine sulphate eye drop 0.01%
Topical atropine sulfate ophthalmic solution 0.01% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.
Atropine sulphate eye drop 0.03%
Topical atropine sulfate ophthalmic solution 0.03% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.
Atropine sulphate eye drop 0.05%
Topical atropine sulfate ophthalmic solution 0.05% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.
Locations (1)
Khyber Teaching Hospital
Peshawar, KPK, Pakistan