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Caffeine in Amblyopia Study (CAS)

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ClinicalTrials.gov Identifier: NCT02594358
Recruitment Status : Withdrawn (Could not recruit)
First Posted : November 3, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Repka, Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Amblyopia Drug: Caffeine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia Caffeine

Arm Intervention/treatment
Active Comparator: Caffeine 20 mg
Patching plus once daily caffeine for 12 weeks
Drug: Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Active Comparator: Caffeine 40 mg
Patching plus once daily caffeine for 12 weeks
Drug: Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING




Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 12 weeks ]
    Quantitative improvement in high resolution visual acuity measured at 3 meters


Secondary Outcome Measures :
  1. Questionnaire [ Time Frame: 12 weeks ]
    A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594358


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Study Chair: Michael X Repka, MD, MBA Johns Hopkins University

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Responsible Party: Michael Repka, Professor of Ophthalmology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02594358     History of Changes
Other Study ID Numbers: NA_00066787
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Keywords provided by Michael Repka, Johns Hopkins University:
Caffeine
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents