Caffeine in Amblyopia Study

Amblyopia Clinical Trial

— CAS  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02594358
• Other study ID #: NA_00066787
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 30, 2015
• Last updated: March 6, 2017
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Drug:
• Caffeine
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Quantitative improvement in high resolution visual acuity measured at 3 meters	12 weeks
Secondary	Questionnaire	A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life	12 weeks