Caffeine in Amblyopia Study

Study Overview
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Brief Summary
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Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial). Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety. Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family. Demonstrate recruitment potential of subjects to participate in a dietary intervention study.

Conditions
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Amblyopia

Intervention / Treatment
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* Drug: Caffeine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Amblyopia from strabismus and amblyopia Exclusion Criteria: Known intolerance to caffeine Diagnosis and/or treatment of attention deficit/hyperactivity disorder Presence of an ocular cause for reduced visual acuity Myopia with a special equivalent -6.00 diopters Current vision therapy or orthoptics - any type Ocular cause for reduced visual acuity Prior intraocular or refractive surgery History of narrow-angle glaucoma Strabismus surgery planned within 16 weeks Nystagmus per se does not exclude the subject if the above visual acuity criteria are met Known skin reactions to patch or bandage adhesives Known allergy or intolerance to food dyes Current treatment with topical atropine eyedrops Menarche, pregnancy or lactation Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeine 20 mg<br>Patching plus once daily caffeine for 12 weeks | Drug: Caffeine<br>* 20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING<br>|
| Active Comparator: Caffeine 40 mg<br>Patching plus once daily caffeine for 12 weeks | Drug: Caffeine<br>* 20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Quantitative improvement in high resolution visual acuity measured at 3 meters | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caffeine