Methylphenidate Effect on Performing Humphrey Visual Fields
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- improvement rate of a repeat visual field result
研究概览
简要总结
Study will include adults with abnormal visual fields. Half of them will be given either methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as controls. All Subjects will also have a complete eye examination, a short questionnaire and a questionnaire to screen for attention deficit disorder. The investigators will compare the visual field results between the 2 tests.
详细描述
Healthy adults with abnormal visual fields will be offered to participate Subjects will have a complete ophthalmic examination including dilated fundus examination.
Subjects with clear explanation for a visual field defect (e.g. optic neuropathy or retinal disorder) will be excluded from the study the subjects will be randomly assigned to the study group and control group using a 1:1 allocation.
Subjects in the study group will be provided with a single tablet of methylphenidate 10 mg to be taken orally 2 hours before repeating their visual field test.
The control group will not receive any placebo Both groups will repeat their visual fields. Both groups will fill out a short questionnaire to evaluate their experience in the second visual field test.
The study group will also fill out a screening questionnaire to rule out previously undiagnosed attention deficit disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abnormal visual fields
- •must be able to swallow pills
排除标准
- •psychiatric disorder
- •ocular disorder which is known to cause abnormal visual fields
- •prescription of psychoactive medications
- •visual acuity lower than 20/100
- •cardiac arrhythmia
- •hypersensitivity to methylphenidate
- •prescription of warfarin
研究组 & 干预措施
methylphenidate provided
the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test
干预措施: methylphenidate (Drug)
methylphenidate provided
the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test
干预措施: guidance (Other)
control
control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation
干预措施: guidance (Other)
结局指标
主要结局
improvement rate of a repeat visual field result
时间窗: immediate
the percentage of subjects whose second (repeat) visual field has improved compared to the first visual field - as interpreted by independent blinded ophthalmologists
次要结局
- Humphrey visual field Mean Deviation (MD)(immediate)
- Humphrey visual field severity score(immediate)
研究者
Bialer
Dr. Omer Y. Bialer
Rabin Medical Center