Caffeine in Amblyopia Study (CAS)
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.
研究概览
研究类型
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Caffeine 20 mg
Patching plus once daily caffeine for 12 weeks
|
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
|
|
有源比较器：Caffeine 40 mg
Patching plus once daily caffeine for 12 weeks
|
20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual acuity
大体时间：12 weeks
|
Quantitative improvement in high resolution visual acuity measured at 3 meters
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Questionnaire
大体时间：12 weeks
|
A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life
|
12 weeks
|
合作者和调查者
调查人员
- 学习椅：Michael X Repka, MD, MBA、Johns Hopkins University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.