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New treatment option for Myopia
Official title Myopia Control: a Comparison Study Between Atropine and MiSight
ClinicalTrials.gov ID: NCT05815784
What this study is testing
What is Atropine?
Atropine is an investigational medicine, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 12
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.