Myopia Control: a Comparison Study Between Atropine and MiSight

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine; Device: MiSight contact lenses

• Study Type: Interventional
• Enrollment (Anticipated): 348
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chia-Ching Wu, MS; Phone Number: 3122274202; Email: chwu@luriechildrens.org
• Study Contact Backup: Name: Hanta Ralay Ranaivo, PhD; Phone Number: 3122276719; Email: hralay@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Chia-Ching Wu, MS
      • Contact: Hanta Ralay Ranaivo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation; No treatment.
Other: Atropine; 0.05% atropine. One drop per eye per day for 2 years.	Drug: Atropine; 0.05% atropine. One drop per eye per day for 2 years.
Other: MiSight contact lenses; MiSight contact lenses. Daily wear for 2 years.	Device: MiSight contact lenses; Daily wear for 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
axial length	change in axial length (as measured by biometry) over a 2-year time period	2 years
Refractive error	change in refractive error over a 2-year time period	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
compliance with treatment	2 years
reported side effects	2 years
success rate of contact lens fitting in the younger children	2 years
contact lens tolerance in the younger children	2 years

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Magdalena Stec, OD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2023
• Primary Completion (Anticipated): March 13, 2026
• Study Completion (Anticipated): March 13, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 2022-5570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No