Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Improvement in synkinesis symptoms
研究概览
简要总结
The purpose of this study is to determine efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic.
详细描述
UAB has a large Facial Nerve Clinic that treats patients with acquired facial nerve palsies and the associated difficulties of swallowing/speaking, and visual field defects from ptosis (a drooping or falling of the upper eyelid) and synkinesis (unwanted contractions of the muscles of the face during attempted movement.). Commonly, patients will experience involuntary eyelid contraction with oral movements like smiling. For eyelid synkinesis causing significant aesthetic or functional difficulty, surgery or botox is often the first line treatment. However, not all patients desire this, and some are poor surgical candidates due to other comorbidities. Botox has been shown to work well for these patients, but can be only partially effective. In addition, patients experience a wearing off period between treatments.
Several eye drops are available for the medical treatment of ptosis, including apraclonidine and 0.1% oxymetazoline. Both are alpha 2 adrenergic agonists, which stimulates Mullers muscle, causing muscle contraction and upper eyelid lifting. In addition, apraclonidine has been shown to be beneficial in patients with blepharospasm in a pilot study by Vijayakumar et. al.
We hypothesize that patients with synkinesis, similar to patients with ptosis and blepharospasm, could have symptomatic improvement with apraclonidine use.
Our study will initially be a pilot study, designed similarly to the Vijayakumar study. If this shows improvement for these patients, our hope is to pursue a randomized control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Ability to speak and comprehend English
- •Ability to consent for themselves
- •Diagnosis of synkinesis affecting eye movement
排除标准
- •Age less than 18 years
- •Unable to speak and comprehend English
- •Unable to consent for themselves
- •Diagnosis of congenital ptosis, Horner syndrome, myasthenia travis, mechanical ptosis
- •Visual field loss from causes unrelated to facial nerve injury
- •Currently receiving monoamine oxidase inhibitors
- •Known hypersensitivity to apraclonidine or other components of the drug under study
研究组 & 干预措施
Treatment Group
Participants will receive the study drug, apraclonidine, per its FDA-approved package labelling
干预措施: Apraclonidine (Drug)
结局指标
主要结局
Improvement in synkinesis symptoms
时间窗: Baseline - 20 minutes after study drug administration
A 30 second video clip will be taken prior to administration of the study drug to record the unwanted movements of the facial muscles around the eyes. Approximately 20 minutes after study drug administration, a second 30-second video clip will be taken. Video clips from all of the participants will be pooled together at the end of the study and given to two independent raters. The raters will use the Sunnybrook Facial Grading System to assess each video and rate improvement of synkinesis after administration of the study drug. The Sunnybrook Facial Grading System rates resting symmetry (a scale of 0-2), symmetry of voluntary movement (a scale of 1-5), and synkinesis (a scale of 0-3), and computes a composite score. The higher the composite score, the better - full range of movement is scored as 100 percent.
次要结局
未报告次要终点
研究者
Benjamin Greene
Principal Investigator
University of Alabama at Birmingham