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

Singapore National Eye Centre

Status and phase: Active, not recruiting; Phase 3

Conditions: Myopia

Treatments: Drug: Atropine sulfate 0.01%; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03140358

R1359/45/2016

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

Premyopia atropine

Active Comparator group

Description:

On Atropine 0.01%

Treatment:

Drug: Atropine sulfate 0.01%

Premyopia placebo

Placebo Comparator group

Description:

On placebo

Treatment:

Drug: Placebo

Low myopia atropine

Active Comparator group

Description:

On Atropine 0.01% daily or every other day

Treatment:

Drug: Atropine sulfate 0.01%

Low myopia placebo

Placebo Comparator group

Description:

On placebo

Treatment:

Drug: Placebo