Myopia Control: a Comparison Study Between Atropine and MiSight

Ann & Robert H Lurie Children's Hospital of Chicago

Status and phase: Enrolling; Phase 2

Conditions: Myopia

Treatments: Drug: Atropine; Device: MiSight contact lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT05815784

2022-5570

Details and patient eligibility

About

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.

Enrollment: 348 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 3 patient groups

Observation

No Intervention group

Description:

No treatment.

Atropine

Other group

Description:

0.05% atropine. One drop per eye per day for 2 years.

Treatment:

Drug: Atropine

MiSight contact lenses

Other group

Description:

MiSight contact lenses. Daily wear for 2 years.

Treatment:

Device: MiSight contact lenses