Changes in Eye Shape With Myopia Management Interventions

Phase 4

Recruiting

• Conditions: Myopia
• Interventions: Device: MiSight 1-day disposable contact lenses; Drug: Atropine Ophthalmic

• Registration Number: NCT06450132
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-10
• Study Start: 2024-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soft multifocal contact lenses	MiSight 1-day disposable 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.
Low-dose atropine	Atropine Ophthalmic	Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.

Primary Outcome Measures

Name	Time	Method
Change in ocular shape	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 Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States