Delaying the Onset of Nearsightedness Until Treatment Study

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-31

Brief Summary

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Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

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Detailed Description

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Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.

Study Groups

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0.01% Atropine

0.01% atropine eye drops

Group Type ACTIVE_COMPARATOR

Atropine Ophthalmic

Intervention Type DRUG

eye drops to be administered once daily

0.03% Atropine

0.03% atropine eye drops

Group Type ACTIVE_COMPARATOR

Atropine Ophthalmic

Intervention Type DRUG

eye drops to be administered once daily

0.05% atropine

0.05% atropine eye drops

Group Type ACTIVE_COMPARATOR

Atropine Ophthalmic

Intervention Type DRUG

eye drops to be administered once daily

Interventions

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Atropine Ophthalmic

eye drops to be administered once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: 6-11 years
* Refractive error measured in spherical equivalent, one eye meets criterion

* 6 years old: 0.50 to +0.38
* 7 years old: 0.50 to +0.25
* 8-11 years old: 0.50 to plano
* Anisometropia: spherical equivalent \<1.50 D
* Astigmatism: \<1.50 in both eyes
* Myopia: Less myopic than -0.74 D, both eyes