CClinicalTrials.gg
Active, not recruitingNCT06450132Updated Jan 27, 2026

Changes in Eye Shape With Myopia Management Interventions

A Phase 4 interventional study of Atropine Ophthalmic and MiSight 1-day disposable contact lenses in Myopia, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Ohio State University · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
21 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugAtropine Ophthalmic

    0.05% atropine ophthalmic solution

  • DeviceMiSight 1-day disposable contact lenses

    soft multifocal contact lenses

06

What researchers measure

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)

    Time frame: baseline to 12 months

Secondary outcomes

  1. Axial elongation (or regression)

    change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit)

    Time frame: baseline to 12 months

  2. Change in accommodative response

    change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K

    Time frame: baseline to 12 months

  3. Change in refractive error

    change in refractive error, as measured with the Grand Seiko WR-5100K

    Time frame: baseline to 12 months

07

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06450132
Lead sponsor
Ohio State University
Responsible party
Donald O Mutti, OD, PhD (EF Wildermuth Foundation Professor in Optometry, Ohio State University) — Principal investigator
First posted
Jun 10, 2024
Start date
Aug 1, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jan 27, 2026

Study contacts

Donald O Mutti, OD, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion