Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
Overview
- Phase
- Phase 2
- Intervention
- Atropine
- Conditions
- Myopia
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Enrollment
- 348
- Locations
- 1
- Primary Endpoint
- axial length
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Magdalena Stec
Assistant Professor of Ophthalmology
Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility 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.
Arms & Interventions
Atropine
0.05% atropine. One drop per eye per day for 2 years.
Intervention: Atropine
MiSight contact lenses
MiSight contact lenses. Daily wear for 2 years.
Intervention: MiSight contact lenses
Outcomes
Primary Outcomes
axial length
Time Frame: 2 years
change in axial length (as measured by biometry) over a 2-year time period
Refractive error
Time Frame: 2 years
change in refractive error over a 2-year time period
Secondary Outcomes
- 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)