0.01% Atropine for Myopia Prevention in Pre-myopia (AMPP study)

Area of Science:

• Ophthalmology
• Pediatric Medicine
• Clinical Research

Background:

• Myopia, or nearsightedness, is a growing global health concern in children.
• Early intervention is crucial to prevent high myopia and associated ocular complications.
• Pre-myopia represents a critical window for myopia control interventions.

Purpose of the Study:

• To assess the efficacy of 0.01% atropine eye drops in preventing myopia progression in children aged 5-12 years with pre-myopia.
• To evaluate the safety profile of 0.01% atropine eye drops during a 12-month treatment period.

Main Methods:

• A randomized controlled trial (ChiCTR2200055482) involving 64 children aged 5-12 years with pre-myopia.
• Participants were randomized 1:1 to receive either 0.01% atropine or placebo eye drops nightly for 12 months.
• The primary outcome measure was the change in cycloplegic spherical equivalent (SE) after 12 months.

Main Results:

• The 0.01% atropine group showed a significantly smaller change in SE compared to placebo (-0.23D vs. -0.49D, p=0.03), indicating a 53% reduction in myopia progression.
• Axial length (AL) elongation was reduced by 19% in the atropine group, though this difference was not statistically significant (p=0.13).
• Larger pupil diameters were observed in the atropine group, but key safety parameters like accommodation amplitude, tear film stability, and intraocular pressure remained comparable between groups.

Conclusions:

• Nightly 0.01% atropine eye drops are effective in delaying myopic shift in pre-myopic children aged 5-12 years over a 1-year period.
• The treatment demonstrated a favorable safety profile with no persistent adverse events.
• While axial elongation was reduced, further research may be needed to confirm its statistical significance.