Study of 0.05% Atropine Eye Drops and Special Spectacle Lenses to Slow Myopia Progression in Children Aged 5 to 11

What this Trial Is About

Researchers are studying ways to slow the progression of myopia nearsightedness in children aged 5 to under 12 years. This trial evaluates the effects of low-concentration atropine eye drops and specially designed spectacle lenses with highly aspherical lenslets, compared to placebo eye drops and standard single-vision spectacles. The study aims to clarify the safety and effectiveness of these treatments during the critical years of eye growth, especially given limited and inconsistent results from previous studies outside Asia. Participants start with a run-in phase to check adherence using nightly artificial tear eye drops and spectacle correction. Then they are randomly assigned to one of four groups in a 2x2 design 0.05% atropine eye drops with single vision lenses, placebo eye drops with single vision lenses, placebo eye drops with highly aspherical lenslets, or atropine eye drops with highly aspherical lenslets. Treatments are given nightly for 24 months, followed by a 6-month period where only single-vision spectacles are worn. Throughout the study, children return every six months for eye exams measuring axial length and refractive error to assess myopia progression. A final visit occurs at 30 months after the no-treatment period. Researchers monitor adherence, visual acuity, and safety over this time. The study is funded by the National Eye Institute and coordinated by the Jaeb Center for Health Research, with equipment and support from Essilor International and Imprimis Rx.

A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control