Myopia Control: a Comparison Study Between Atropine and MiSight
- Registration Number
- NCT05815784
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 348
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MiSight contact lenses MiSight contact lenses MiSight contact lenses. Daily wear for 2 years. Atropine Atropine 0.05% atropine. One drop per eye per day for 2 years.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States