Delaying onset of nearsightedness trial Chairs grant

University Of Houston, Houston TX

Investigators

Linked publications, trials & patents

Abstract

Project Summary/Abstract The prevalence of nearsightedness (myopia) is increasing worldwide, and so is the prevalence of high myopia. Myopia, especially high myopia, is associated with reduced vision-related quality of life and sight- threatening complications such as glaucoma, retinal detachment, and myopic maculopathy. Delaying the onset of myopia when the eye is known to be growing the fastest may decrease how myopic a child ultimately becomes and may improve the person’s vision-related quality of life and reduce the risk of sight-threatening complications later in life. To date, all myopia control interventions are prescribed after the onset of myopia. Recent studies in Asia indicate that daily administration of 0.05% low-concentration atropine delays the onset of myopia. However, the results of recent clinical trials to slow myopia progression in children who are already myopic have been inconsistent between the United States and Asia, demonstrating the importance of studies in a US population. A prospective cohort study estimated that for every year later that myopia develops, a person is –0.86 D less myopic and 2.9 times less likely to become highly myopic. Based on these results, a treatment to delay the onset of myopia could lower how myopic a person is as an adult. This proposal aims to conduct a two-year, multi-center randomized clinical trial to determine whether 0.05% atropine eye drops administered to children at greatest risk of becoming myopic will delay the onset of myopia. We will enroll pre-myopic children (6-11 years old, inclusive) across 14 clinic centers in the United States and randomly assign them to nightly administration of either 0.05% low-concentration atropine or placebo eye drops. The primary endpoint is whether each participant develops myopia in at least one eye during the two-year clinical trial, as measured by cycloplegic autorefraction. We will determine if there is a difference in the probability of children becoming myopic between those randomly assigned to use 0.05% low- concentration atropine versus placebo over two years. The goal of myopia control is to slow eye growth to prevent mechanical changes due to a longer than normal eye. Previous myopia studies have found inconsistencies between changes in refractive error and axial eye growth. We will determine whether 0.05% low-concentration atropine slows axial elongation of the eye prior to myopia onset compared to placebo. The results of this study could improve care of children in the United States at greatest risk of developing myopia by determining whether treatment can be initiated prior to myopia onset.