Clinical trial NCT05815784: Myopia Control: a Comparison Study Between Atropine and MiSight
Official title: Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myopia
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 348
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: axial length
timeFrame: 2 years
measure: Refractive error
timeFrame: 2 years
Secondary outcomes:
measure: compliance with treatment
timeFrame: 2 years
measure: reported side effects
timeFrame: 2 years
measure: success rate of contact lens fitting in the younger children
timeFrame: 2 years
measure: contact lens tolerance in the younger children
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Magdalena Stec, OD
role: PRINCIPAL_INVESTIGATOR
References: