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Caffeine in Amblyopia Study (CAS)

Primary Purpose

Amblyopia

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Caffeine

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Caffeine

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Caffeine 20 mg

Caffeine 40 mg

Arm Description

Patching plus once daily caffeine for 12 weeks

Outcomes

Primary Outcome Measures

Visual acuity

Quantitative improvement in high resolution visual acuity measured at 3 meters

Secondary Outcome Measures

Questionnaire

A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life

Full Information

NCT ID

NCT02594358

First Posted

October 30, 2015

Last Updated

March 6, 2017

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT02594358

Brief Title

Caffeine in Amblyopia Study

Acronym

CAS

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Could not recruit

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amblyopia

Keywords

Caffeine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caffeine 20 mg

Arm Type

Active Comparator

Arm Description

Patching plus once daily caffeine for 12 weeks

Arm Title

Caffeine 40 mg

Arm Type

Active Comparator

Arm Description

Patching plus once daily caffeine for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Caffeine

Intervention Description

20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Primary Outcome Measure Information:

Title

Visual acuity

Description

Quantitative improvement in high resolution visual acuity measured at 3 meters

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Questionnaire

Description

A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael X Repka, MD, MBA

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Chair

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Caffeine in Amblyopia Study

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