Myopia Control: a Comparison Study Between Atropine and MiSight

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05815784
• Other study ID #: 2022-5570
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 20, 2023
• Est. completion date: March 13, 2026

Study information

• Verified date: April 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Chia-Ching Wu, MS
• Phone: 3122274202
• Email: chwu[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 348
• Est. completion date: March 13, 2026
• Est. primary completion date: March 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine
0.05% atropine. One drop per eye per day for 2 years.

Device:
• MiSight contact lenses
Daily wear for 2 years.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial length	change in axial length (as measured by biometry) over a 2-year time period	2 years
Primary	Refractive error	change in refractive error over a 2-year time period	2 years
Secondary	compliance with treatment		2 years
Secondary	reported side effects		2 years
Secondary	success rate of contact lens fitting in the younger children		2 years
Secondary	contact lens tolerance in the younger children		2 years