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Completed

NCT Number: NCT02130167

Low Concentration Atropine for Myopia Progression in School Children

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.

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Key information

Conditions

Myopia Progression

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Atropine

Drug

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

Primary outcomes

  1. Cycloplegic spherical refraction change

    Time frame: 1 year

    Cycloplegic spherical refraction change is the main indicator of the myopia progression.

Secondary outcomes

  1. Axial length change

    Time frame: 1 year

    Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)

Other outcomes

  1. pupil size

    Time frame: 6 months

    Using computer scaling software. unit: millimeter(mm)

  2. accommodation

    Time frame: 6 months

    Using accommodometer to measuer accommodation. Unit: diopeter

  3. Questionnaire

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Low Concentrations of Atropine for Controlling Myopia Progression in School Children

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 5, 2014
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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