Eye Drops Study for Myopia Control in Schoolchildren

Study Overview
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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.

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.

Official Title
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Eye Drops Study for Myopia Control in Schoolchildren

Conditions
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Myopia, Progressive, Atropine Allergy

Intervention / Treatment
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* Drug: eye drops


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.01% atropine<br>children who received 0.01% atropine for myopia | Drug: eye drops<br>* children who received daily eye drops for myopia<br>|
| Experimental: 0.005% atropine<br>children who received 0.005% atropine for myopia | Drug: eye drops<br>* children who received daily eye drops for myopia<br>|
| Experimental: 0.25% Ketorolac<br>children who received 0.25% Ketorolac for myopia | Drug: eye drops<br>* children who received daily eye drops for myopia<br>|
| Experimental: 0.01% atropine plus 0.25% Ketorolac<br>children who received 0.01% atropine plus 0.25% Ketorolac for myopia | Drug: eye drops<br>* children who received daily eye drops for myopia<br>|
| Experimental: 0.005% atropine plus 0.25% Ketorolac<br>children who received 0.005% atropine plus 0.25% Ketorolac for myopia | Drug: eye drops<br>* children who received daily eye drops for myopia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) | Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression. | 1 year | 
| Axial length change (mm) measured by non-contact biometry | Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (mmHg) by non-contact tonometer | measures Intraocular pressure (mmHg) by non-contact tonometer | 1 year | 
| Accommodation (diopter) by accommodometer | Accommodation change (diopter) by accommodometer is another indicator of the myopia progression. | 1 year | 
| Pupil size (mm) by electronic rule | measures Pupil size (mm) by electronic rule | 1 year | 
| Anterior chamber depth (mm) measured by non-contact biometry | measures Anterior chamber depth (mm) measured by non-contact biometry | 1 year | 
| Posterior chamber depth (mm) measured by non-contact biometry | measures Posterior chamber depth (mm) measured by non-contact biometry | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work