Friday, May 9, 2025
5/9/2025
Feasibility of study to delay myopia onset - 7. 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 sight-threatening complications such as myopic maculopathy and retinal detachment. Slowing the progression of myopia may reduce the risk of sight- threatening complications and improve a person’s quality of life. To date, all myopia control methods are prescribed after the onset of the disease. A retrospective cohort study indicates that daily administration of low concentration atropine may delay the onset of myopia, and a prospective cohort study of 928 myopic children examined at age 11 estimated that for every year later myopia develops, a person is -0.86 less myopic or 2.86 times more likely to be highly myopic. Therefore, delaying the onset of myopia could lower the amount of myopia experienced in adulthood and lower the risk of sight-threatening complications. This proposal aims to establish the feasibility of conducting a randomized clinical trial to determine whether 0.05% atropine eye drops administered to children at risk of becoming myopic will delay the onset of myopia. Before conducting the randomized clinical trial, we must determine the feasibility of finding 6-11 year old pre- myopic children and establish the feasibility of enrolling them in a future randomized clinical trial to delay the onset of myopia. We will establish the feasibility of enrolling 6-11 year old children in a randomized clinical trial to determine if we can delay the onset of myopia by comparing the time to myopia onset of children randomly assigned to daily administration of 0.05% atropine or placebo. This will take place via two protocols: 1. We will measure non-cycloplegic retinoscopy on at least 3,500 children (at least 250 children at each of 14 clinic sites) to determine the proportion of children who would meet the non-cycloplegic retinoscopy entry criteria. 2. We will invite 5 children per clinical site to participate in a two-week study to establish the feasibility of enrolling pre-myopic children in a randomized clinical trial and measure compliance of eye drop administration. All of this information will help us determine how many children we must screen in order to enroll one child in a future randomized clinical trial to delay the onset of myopia. We will also create a detailed manual of procedures that will improve standardization of outcome measures, train examiners, and answer many questions that may arise during the randomized clinical trial.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).