Low Concentration Atropine for Myopia Progression in School Children

Low Concentrations of Atropine for Controlling Myopia Progression in School Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02130167

Enrollment

Registered

2014-05-05

Start date

2012-08-31

Completion date

2017-08-31

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia Progression

Keywords

Myopia progression, Low concentration atropine

Brief summary

Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Interventions

DRUGAtropine

Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Inclusion criteria

Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Exclusion criteria

strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Design outcomes

Primary

Measure	Time frame	Description
Cycloplegic spherical refraction change	1 year	Cycloplegic spherical refraction change is the main indicator of the myopia progression.

Secondary

Measure	Time frame	Description
Axial length change	1 year	Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)

Other

Measure	Time frame	Description
pupil size	6 months	Using computer scaling software. unit: millimeter(mm)
accommodation	6 months	Using accommodometer to measuer accommodation. Unit: diopeter
Questionnaire	baseline and 6 months	Questionnaire written by patients and their parents about how many hours per week of near work (ex. computer/video game, reading, piano playing...) and outdoor activities, the compliance of atropine use, discomfort after atropine use (ex. photophobia or blurred vision when near work)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026