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Myopia Control: a Comparison Study Between Atropine and MiSight

Myopia Control: a Comparison Study Between Atropine and MiSight

Recruiting
5-12 years
All
Phase 2

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Overview

This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.

Eligibility

Inclusion Criteria:

  • Children age of 5-12 years old at their baseline exam
  • Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
  • Gestational age ≥ 32 weeks.
  • Birth weight >1500g.

Exclusion Criteria:

  • Current or previous form of myopia control
  • Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
  • Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
  • Abnormality of cornea, lens, central retina, iris, or ciliary body
  • Current or prior history of manifest strabismus, amblyopia, or nystagmus
  • Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
  • Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
  • Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
  • Abnormality of the cornea, lens, central retina, iris, or ciliary body.
  • Prior eyelid, strabismus, intraocular, or refractive surgery.
  • Down syndrome or cerebral palsy.
  • Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
  • Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
  • Any condition that in the judgement of the investigator could potentially influence refractive development.
  • Existing conditions that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, diabetes mellitus, pre-diabetes)
  • Inability to comprehend and/or perform any study-related clinical tests

Study details
    Myopia

NCT05815784

Ann & Robert H Lurie Children's Hospital of Chicago

12 September 2025

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