Changes in Eye Shape With Myopia Management Interventions

June 4, 2024 updated by: Donald O Mutti, OD, PhD, Ohio State University

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

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marielle G. Reidy, OD, MS
  • Phone Number: 4409916205
  • Email: reidy.39@osu.edu

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
soft multifocal contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

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)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

Clinical Trials on Atropine Ophthalmic

3
Subscribe