Changes in Eye Shape With Myopia Management Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

The participants and the examining investigator will not be masked to intervention. All measurements are objective in nature and not subject to examiner bias. All data images acquired will be coded to obscure participant ID by a study team member masked to intervention. This coding will allow for the examining investigator to complete image processing while masked to randomization assignment, thereby minimizing the chance of bias.

Study Groups

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Observation

Participants randomized to the observation arm will receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Atropine Ophthalmic

Intervention Type DRUG

0.05% atropine ophthalmic solution

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.

Group Type EXPERIMENTAL

MiSight 1-day disposable contact lenses

Intervention Type DEVICE

soft multifocal contact lenses

Interventions

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Atropine Ophthalmic

0.05% atropine ophthalmic solution

Intervention Type DRUG

MiSight 1-day disposable contact lenses

soft multifocal contact lenses

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes