Preventing Nearsightedness in Children Ages 6 to 11 Using Nightly 0.05% Atropine Eye Drops Compared to Placebo

What this Trial Is About

Researchers are investigating whether nightly eye drops containing 0.05% atropine can delay the onset of nearsightedness myopia in children aged 6 to 11 years who are at high risk of developing this condition. This study compares atropine drops to placebo drops in a randomized clinical trial involving 606 children across multiple centers. The main goal is to measure the two-year cumulative incidence of myopia and to see if atropine slows eye growth. Participants will be randomly assigned to receive either 0.05% atropine eye drops or placebo drops nightly in both eyes at bedtime. The study will last at least two years, during which children will be monitored every six months to assess the onset of nearsightedness and changes in eye growth. The atropine solution is specially prepared by a pharmacy, and the placebo matches the treatment minus the atropine. Throughout the study, children will visit the clinic every six months for eye exams using tools like the Myopia Master to measure eye shape and vision changes. Researchers will track the development of myopia, axial elongation, and progression of refractive error. Safety and adherence will be monitored, including a run-in period to ensure compliance with daily drops. The total participation time is at least two years, allowing thorough evaluation of the treatments effects.

Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial