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OpenTrials
Active, Not Recruiting

NCT Number: NCT06450132

Changes in Eye Shape With Myopia Management Interventions

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine Ophthalmic

Drug

0.05% atropine ophthalmic solution

MiSight 1-day disposable contact lenses

Device

soft multifocal contact lenses

Primary outcomes

  1. Change in ocular shape

    Time frame: baseline to 12 months

    ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)

Secondary outcomes

  1. Axial elongation (or regression)

    Time frame: baseline to 12 months

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

  2. Change in accommodative response

    Time frame: baseline to 12 months

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

  3. Change in refractive error

    Time frame: baseline to 12 months

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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