The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

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

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2025-12-31

Brief Summary

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Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

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Detailed Description

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High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Premyopia atropine

On Atropine 0.01%

Group Type ACTIVE_COMPARATOR

Atropine sulfate 0.01%

Intervention Type DRUG

Atropine 0.01%

Premyopia placebo

On placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Low myopia atropine

On Atropine 0.01% daily or every other day

Group Type ACTIVE_COMPARATOR

Atropine sulfate 0.01%

Intervention Type DRUG

Atropine 0.01%

Low myopia placebo

On placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Atropine sulfate 0.01%

Atropine 0.01%

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. One parent with myopia (\<-3D in at least one eye)
2. SE +1.00D to -1.50D
3. Astigmatism \< = 1.50D
4. Distance vision logMAR 0.2 or better in both eyes
5. Intraocular pressure of not greater than 21 mmHg
6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria

1. Any eye or systemic disease that affect vision or refractive error
2. Conditions where topical atropine contraindicated
3. Previous use of atropine or pirenzepine
4. Known past/current amblyopia or strabismus

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes