Study Results
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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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2014-10-31
2018-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Caffeine 20 mg
Patching plus once daily caffeine for 12 weeks
Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
Caffeine 40 mg
Patching plus once daily caffeine for 12 weeks
Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
Interventions
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Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
7 Years
13 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Michael Repka
Professor of Ophthalmology
Principal Investigators
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Michael X Repka, MD, MBA
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NA_00066787
Identifier Type: -
Identifier Source: org_study_id
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