Comparing Atropine 0.5% and 0.05% Eye Drops to Prevent Myopia Progression in Children Aged 6 to 11

What this Trial Is About

Researchers are evaluating the effectiveness of two different doses of Atropine eye drops 0.05% and 0.5% in slowing the progression of axial length growth in European children aged 6 to 11 years with progressive myopia. The study aims to compare how well these doses prevent worsening of myopia, assess safety, adherence to treatment, and reasons why some children might not respond to the treatment. Progressive myopia can lead to serious eye problems, so preventing its advancement in childhood is important to reduce risks of vision loss later in life. Participants in this study will be randomly assigned to receive either Atropine 0.05% or Atropine 0.5% eye drops. They will administer one drop in each eye once daily at bedtime for 3 years. After this treatment phase, participants will be observed for an additional 2 years without treatment to monitor long-term effects. This design helps compare the two doses in terms of controlling eye growth and side effects over time. During the study, children will have their eye measurements taken to track axial length progression, visual function tests, and assessments of their response to treatment and any side effects. Researchers will also monitor adherence to the eye drop regimen and evaluate quality of life changes over 5 years. The primary outcome is the change in axial length after 3 years of treatment, with additional follow-up to 5 years. Safety and vision tests will be performed regularly to ensure participant well-being throughout the trial.

MAD Trial: Myopia Atropine Dose