Myopia
Conditions
Brief 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.
Interventions
DRUGAtropine
0.05% atropine. One drop per eye per day for 2 years.
DEVICEMiSight contact lenses
Daily wear for 2 years.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| axial length | 2 years | change in axial length (as measured by biometry) over a 2-year time period |
| Refractive error | 2 years | change in refractive error over a 2-year time period |
Secondary
| Measure | Time frame |
|---|---|
| compliance with treatment | 2 years |
| reported side effects | 2 years |
| success rate of contact lens fitting in the younger children | 2 years |
| contact lens tolerance in the younger children | 2 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMagdalena Stec, OD
Ann & Robert H Lurie Children's Hospital of Chicago
Outcome results
None listed