Eye Drops Study for Myopia Control in Schoolchildren

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-20

Study Completion Date

2019-12-31

Brief Summary

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The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.

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Detailed Description

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Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.

Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.

Conditions

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Myopia, Progressive Atropine Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

children who received daily eye drops for myopia

Interventions

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eye drops

children who received daily eye drops for myopia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
* Must be able to use eye drops

Exclusion Criteria

* astigmatism -1.50 D or greater
* strabismus
* amblyopia
* cataract
* glaucoma
* any ocular diseases ocular surgery
* history of systemic diseases (ex. asthma, heart disease...)
* contact lenses user
* orthokeratology user

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No