Caffeine in Amblyopia Study

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Caffeine

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