Caffeine in Amblyopia Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Amblyopia from strabismus and amblyopia
排除标准
- •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
研究组 & 干预措施
Caffeine 40 mg
Patching plus once daily caffeine for 12 weeks
干预措施: Caffeine (Drug)
Caffeine 20 mg
Patching plus once daily caffeine for 12 weeks
干预措施: Caffeine (Drug)
结局指标
主要结局
Visual acuity
时间窗: 12 weeks
Quantitative improvement in high resolution visual acuity measured at 3 meters
次要结局
- Questionnaire(12 weeks)
研究者
Michael Repka
Professor of Ophthalmology
Johns Hopkins University