Myopia Control: a Comparison Study Between Atropine and MiSight

Study Overview
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Brief Summary
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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.

Official Title
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Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%

Conditions
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Myopia

Intervention / Treatment
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* Drug: Atropine
* Device: MiSight contact lenses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>No treatment. | |
| Other: Atropine<br>0.05% atropine. One drop per eye per day for 2 years. | Drug: Atropine<br>* 0.05% atropine. One drop per eye per day for 2 years.<br>|
| Other: MiSight contact lenses<br>MiSight contact lenses. Daily wear for 2 years. | Device: MiSight contact lenses<br>* Daily wear for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length | change in axial length (as measured by biometry) over a 2-year time period | 2 years | 
| Refractive error | change in refractive error over a 2-year time period | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |