Effects of Vertical Prism on the Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria: A Randomized, Double-blinded, Placebo-controlled, Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms
研究概览
简要总结
The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription.
The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria
- •Must have symptoms of dizziness or headache or both:
- •Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness
- •Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes
- •Duration of symptoms greater than 4 months
- •Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM&R, Ophthalmology).
- •The patient (or their representative) must be able and willing to fill out extra paperwork
- •All Patients to be seen by same Optometrist for all visits
- •Must be willing to wear glasses.
- •The patient (or their representative) must be able to sign informed consent
- •Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
- •Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated
- •Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness
排除标准
- •Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"
- •Previous eye injury or eye operation (including RK and Lasik)
- •Diagnosis of glaucoma
- •Diagnosis of cataracts
- •Diagnosis of proptosis
- •Previous C-spine surgery / fusion
- •Previous Rx contains prismatic correction
- •>18 PD of exophoria
- •> 4 PD of vertical heterophoria on Initial Exam
结局指标
主要结局
Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms
时间窗: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed
次要结局
- Evidence that a new survey tool developed by the authors to assess changes / improvement in dizziness, headache and anxiety associated with Vertical Heterophoria correlates to validated, self-administered survey tools for these same symptoms(New survey tool to be administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed)