Changes in Eye Shape With Myopia Management Interventions

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450132
• Other study ID #: 2023H0321
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Ohio State University
• Contact: Marielle G. Reidy, OD, MS
• Phone: 4409916205
• Email: reidy.39[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine Ophthalmic
0.05% atropine ophthalmic solution

Device:
• MiSight 1-day disposable contact lenses
soft multifocal contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

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