Changes in Eye Shape With Myopia Management Interventions

NCT06450132 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 2023H0321
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Axial elongation (or regression)

  baseline to 12 months

• Change in accommodative response

  baseline to 12 months

• Change in refractive error

  baseline to 12 months

Study Arms (3)

Observation

NO INTERVENTION

Participants randomized to the observation arm will receive no intervention.

Low-dose atropine

EXPERIMENTAL

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

Soft multifocal contact lenses

EXPERIMENTAL

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

Interventions

Atropine Ophthalmic DRUG

0.05% atropine ophthalmic solution

Low-dose atropine

MiSight 1-day disposable contact lenses DEVICE

soft multifocal contact lenses

Soft multifocal contact lenses

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Donald O Mutti, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants and the examining investigator will not be masked to intervention. All measurements are objective in nature and not subject to examiner bias. All data images acquired will be coded to obscure participant ID by a study team member masked to intervention. This coding will allow for the examining investigator to complete image processing while masked to randomization assignment, thereby minimizing the chance of bias.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EF Wildermuth Foundation Professor in Optometry

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)