Caffeine in Amblyopia Study (CAS)

Johns Hopkins University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Amblyopia

Treatments

Drug: Caffeine

Study type

Interventional

Funder types

Other

Identifiers

NCT02594358

NA_00066787

Details and patient eligibility

About

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.

Sex

All

Ages

7 to 13 years old

Volunteers

No 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