Caffeine in Amblyopia Study

Phase 1

Withdrawn

• Conditions: Amblyopia
• Interventions: Drug: Caffeine

• Registration Number: NCT02594358
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caffeine 20 mg	Caffeine	Patching plus once daily caffeine for 12 weeks
Caffeine 40 mg	Caffeine	Patching plus once daily caffeine for 12 weeks

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 weeks	Quantitative improvement in high resolution visual acuity measured at 3 meters

Secondary Outcome Measures

Name	Time	Method
Questionnaire	12 weeks	A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States