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OpenTrials
Active, Not Recruiting

NCT Number: NCT05815784

Myopia Control: a Comparison Study Between Atropine and MiSight

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

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

MiSight contact lenses

Device

Daily wear for 2 years.

Primary outcomes

  1. axial length

    Time frame: 2 years

    change in axial length (as measured by biometry) over a 2-year time period

  2. Refractive error

    Time frame: 2 years

    change in refractive error over a 2-year time period

Secondary outcomes

  1. compliance with treatment

    Time frame: 2 years

  2. reported side effects

    Time frame: 2 years

  3. success rate of contact lens fitting in the younger children

    Time frame: 2 years

  4. contact lens tolerance in the younger children

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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