Caffeine in Amblyopia Study
| Status: | Withdrawn |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 7 - 13 |
| Updated: | 3/8/2017 |
| Start Date: | October 2014 |
| End Date: | December 2018 |
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-5492
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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