Actively Recruiting

Phase 2
Age: 5Years - 12Years
All Genders
NCT05815784

Myopia Control: a Comparison Study Between Atropine and MiSight

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-11-19

348

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Myopia Control: a Comparison Study Between Atropine and MiSight

Who Can Participate

Age: 5Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 12 years at baseline exam
  • Spherical equivalent refractive error from +0.50D (minimal farsightedness) to -7.50D (high myopia)
  • Gestational age of 32 weeks or more
  • Birth weight greater than 1500 grams
Not Eligible

You will not qualify if you...

  • Current or previous use of any myopia control treatment
  • Use of bifocal, progressive-addition, or multifocal contact lenses currently or previously
  • Known allergy to atropine or intolerance to contact lenses (allergy to one allows enrollment in other group)
  • Abnormalities in cornea, lens, central retina, iris, or ciliary body
  • History of strabismus, amblyopia, or nystagmus
  • Previous treatment with atropine, pirenzepine, or other anti-muscarinic agents
  • Use of orthoK, rigid gas permeable, or other myopia-reducing contact lenses
  • Prior eyelid, strabismus, intraocular, or refractive surgery
  • Down syndrome or cerebral palsy
  • Diseases affecting eye accommodation, vergence, or movement (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
  • Existing ocular or systemic/neurodevelopmental conditions influencing refractive development
  • Any condition potentially influencing refractive development as judged by investigator
  • Conditions affecting long-term eye health or requiring medications that may interact adversely with study treatments
  • Inability to understand or perform study-related clinical tests

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

C

Chia-Ching Wu, MS

CONTACT

H

Hanta Ralay Ranaivo, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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