Caffeine in Amblyopia Study (CAS)

March 6, 2017 updated by: Michael Repka, Johns Hopkins University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Study Chair: Michael X Repka, MD, MBA, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00066787

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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