Myopia Control: a Comparison Study Between Atropine and MiSight
Running, not enrolling · Phase 2
Conditions studied: Myopia
In brief
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.
Key facts
- Study ID
- NCT05815784
- Run by
- Ann & Robert H Lurie Children's Hospital of Chicago
- People needed
- 348
- Starts
- 2023-05-02
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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