A New More Efficient Cycloplegia Scheme

Study Overview
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Brief Summary
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The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)

Official Title
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A New More Efficient Cycloplegia Scheme

Conditions
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Refractive Errors

Intervention / Treatment
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* Drug: Cyclopentolate
* Drug: Cyclopentolate+tropicamide+phenylephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 1 and 10 years Exclusion Criteria: Strabismus Ocular surgery Another ocular disease than ametropias (i.e uveitis, cataract) Cardiovascular or neurologic disease. Allergy to any of drugs used in the study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclopentolate<br> | Drug: Cyclopentolate<br>* Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.<br>* Other names: Cyclogyl;Drug: Cyclopentolate+tropicamide+phenylephrine<br>* New scheme. All drugs together and wait 30 minutes for retinoscopy<br>* Other names: Cyclogyl, Mydfrin, Mydriacyl;|
| Experimental: Cyclopentolate+tropicamide+phenylephrine<br> | Drug: Cyclopentolate<br>* Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.<br>* Other names: Cyclogyl;Drug: Cyclopentolate+tropicamide+phenylephrine<br>* New scheme. All drugs together and wait 30 minutes for retinoscopy<br>* Other names: Cyclogyl, Mydfrin, Mydriacyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Spherical equivalent | In the first and second visit the spherical equivalent will be measured with retinoscopy. Change in spherical equivalent refraction from first visit to day average 18 days (second visit). On both visits the patient will receive different cyclopegia schemes. | average 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spherical refraction | Change in spherical refraction between visit 1 and 2. | average 18 days | 
| Change in cylindrical refraction | Change in cylindrical refraction between visit 1 and 2 | average 18 days | 
| iris motility | both schemes are effective in cycloplegia ? In visit 1 and 2 the iris motility after the cyclopegic schemes will be evaluated | average 18 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refraction in children, cycloplegia, cycloplegic agents, cycloplegic schemes, cyclopentolate