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

2022-5570

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.

2023-04-20

2026-03-13

2026-03-13

Not yet recruiting

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 348, 'type': 'ESTIMATED'}}

2023-04-18