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University of Houston and Ohio State to Lead $25M National Trial Testing Atropine to Prevent Myopia Onset

09/18/2025

The University of Houston (UH) and The Ohio State University (OSU) are co-leading a first-of-its-kind clinical trial to determine whether low-concentration atropine eye drops can delay the onset of nearsightedness in children and lessen its progression over a lifetime. The National Eye Institute has awarded two grants totaling $25 million to launch the 'Delaying the Onset of Nearsightedness Until Treatment (DONUT) Study.'

“The more nearsighted, or myopic, someone becomes, the greater their risk of sight-threatening complications later on as an adult including myopic degeneration, retinal detachment, glaucoma,” said David Berntsen, OD, PhD, co-principal investigator and Golden-Golden Professor of Optometry at UH. “Our goal is to ultimately decrease how myopic someone becomes to hopefully reduce their risk of complications later in life.”

Dr. Berntsen is co-leading the study with Jeffrey Walline, OD, PhD, professor at OSU’s College of Optometry, and Lisa Jordan, PhD, research professor and director of OSU’s Data Coordination and Analysis Center.

According to UH, the study is important because of several factors:

  • Unmet need: Prior U.S. and Asian studies suggest low-dose atropine slows progression after myopia begins; only an Asian study has examined delaying onset. No US trial has tested prevention before diagnosis—until now.

  • Public health impact: Myopia already affects at least one-third of U.S. adults and is rising, with downstream risks and costs in the $4–$7B range annually.

  • Practice relevance: If effective, pre-emptive atropine could redefine risk-based screening and early intervention strategies in primary eye care.

Study at a glance

  • Design & Sites: Multicenter, randomized, placebo-controlled clinical trial at UH, OSU, and 12 additional U.S. centers

  • Participants: >600 children, ages 6–11, identified as high-risk for developing myopia based on reduced age-appropriate hyperopia by third grade (predictive accuracy ~90% for myopia by eighth grade)

  • Intervention: Nightly 0.05% low-concentration atropine vs placebo for 2 years

  • Rescue/Standard Care: Children in the placebo arm who develop myopia during the study will start atropine. All children who become myopic receive an annual voucher for corrective lenses

  • Primary outcomes:

    • Incidence reduction: Predicted drop in new myopia from 20% (placebo) to 10% (atropine)

    • Eye growth: 30% reduction in pre-myopic axial elongation over the study period

  • Natural history context: Ocular growth accelerates just before myopia onset—typically ages 8–10—and progression often continues until about age 16

Previous evidence in the US and Asia shows low-dose atropine can slow myopia progression after onset. One Asian study also reported delayed onset with atropine. The DONUT Study extends this trajectory by initiating therapy before diagnosis in high-risk children, aiming to shift the incidence curve rather than only mitigate progression.

Drs. Berntsen, Walline, and Jordan previously co-led trials demonstrating that multifocal contact lenses—particularly high add power designs—significantly slow progression in myopic children as young as seven. Follow-up data reported in 2025 indicated sustained benefits after treatment cessation, reinforcing the value of early, active management.

“Our previous work has shown that young children are very successful with treatments to slow the progression of myopia. This new study will now look to see if we can delay when a child first becomes myopic,” Dr. Berntsen said.

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