Comparing Atropine and MiSight for controlling myopia in children
Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
This study is testing whether atropine eye drops or MiSight contact lenses work better to help control nearsightedness in children aged 5 to 12.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05815784 on ClinicalTrials.gov |
What this trial studies
This research project aims to compare the effectiveness of atropine eye drops and MiSight contact lenses in controlling myopia in children aged 5 to 12 years. The study will assess the pharmacological and optical methods of myopia control while also examining the biometry of the pediatric eye, which is crucial for understanding myopia progression. By gathering this data, the study seeks to enhance best practices for managing myopia in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 12 years with a spherical equivalent refractive error ranging from +0.50D to -7.50D.
Not a fit: Patients who have previously undergone myopia control treatments or have certain eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies for controlling myopia progression in children, potentially reducing the risk of severe vision problems later in life.
How similar studies have performed: Other studies have shown promising results in myopia control using atropine and optical interventions, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Magdalena Stec, OD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Chia-Ching Wu, MS
- Email: chwu@luriechildrens.org
- Phone: 3122274202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.