Changes in Eye Shape With Myopia Management Interventions

The Ohio State University

Status and phase: Active, not recruiting; Phase 4

Conditions: Myopia

Treatments: Device: MiSight 1-day disposable contact lenses; Drug: Atropine Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT06450132

2023H0321

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 21 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Observation

No Intervention group

Description:

Participants randomized to the observation arm will receive no intervention.

Low-dose atropine

Experimental group

Description:

Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.

Treatment:

Drug: Atropine Ophthalmic

Soft multifocal contact lenses

Experimental group

Description:

Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.

Treatment:

Device: MiSight 1-day disposable contact lenses