Myopia Control: a Comparison Study Between Atropine and MiSight

• Status: Not yet recruiting
• Trial end date: 2026-03-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Treatments: Atropine

Criteria

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