Changes in Eye Shape With Myopia Management Interventions

Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses

The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:

• do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
• are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?

Participants will:

• have multiple different types of photos taken
• have their prescription for glasses/contacts checked
• have their eye health checked, including the use of dilating eye drops
• be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
• will complete five study visits over the course of 12 months

Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine Ophthalmic; Device: MiSight 1-day disposable contact lenses

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• best corrected visual acuity of 20/25 or better in each eye
• nearsighted
• current contact lens wearer
• normal binocular vision (to be determined by an examiner at the first study visit)

Exclusion Criteria:

• eye diseases (including lazy eye or eye turn)
• pregnant, nursing, or planning a pregnancy in the next 12 months
• history of refractive surgery (e.g., LASIK)
• history of myopia control treatment
• sensitivity to anesthetics or preservative in eye drops
• difficulty with pupillary dilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation; Participants randomized to the observation arm will receive no intervention.
Experimental: Low-dose atropine; Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.	Drug: Atropine Ophthalmic; 0.05% atropine ophthalmic solution
Experimental: Soft multifocal contact lenses; Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.	Device: MiSight 1-day disposable contact lenses; soft multifocal contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ocular shape	ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)	baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial elongation (or regression)	change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit)	baseline to 12 months
Change in accommodative response	change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K	baseline to 12 months
Change in refractive error	change in refractive error, as measured with the Grand Seiko WR-5100K	baseline to 12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Donald O Mutti, OD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Atropine
• Other Study ID Numbers: 2023H0321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes