A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in palpebral gap from the baseline.
研究概览
简要总结
To develop a real-time wearable device based on the principle of magnetic force for temporary management of lagophthalmos, and evaluate its efficacy and safety, including synchronous blinks and eye closure, blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid, by performing a human trial on patients with lagophthalmos.
详细描述
The wearable system includes a near-infrared (NIR) light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and receiver (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet affixed to the paralytic upper eyelid, and a bio-signal acquisition module together with a power supply unit providing a wired connection to the NIR sensor and permanent electromagnetic actuator. The palpebral gap was measured before and after the wearing of the device. The efficacy of the device prototype was assessed in terms of synchronous blinks and eye closure. Subjective sensation and complications were assessed by blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid. After the completion of the study procedure, eyelid skin condition was examined.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
- •Aged 18 years old or older
排除标准
- •Upper eyelid scar, contracture, fibrosis, and atrophy due to previous surgical intervention(s)
- •Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
- •Children younger than 18 years of age
结局指标
主要结局
Changes in palpebral gap from the baseline.
时间窗: 10 minutes after completion of the second testing within 12 months
The investigators assess changes in distance between the upper and lower eyelid margins at the axis of the pupil (palpebral gap, millimeter) before and during the intervention by a ruler and/or a software.
Changes in visual acuity (blurred vision) from the baseline.
时间窗: 10 minutes after completion of the second testing within 12 months
Assess visual acuity by Snellen test before and after the intervention.
Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.
时间窗: 10 minutes after completion of the testing
The investigator assess discomfort of the eyeball, and examine erythema or swelling over upper eyelid and facial skin after the intervention. (The score 0 indicating no discomfort, score 1 indicating positive discomfort)
Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.
时间窗: 10 minutes after completion of the second testing within 12 months
The investigator assess discomfort of the eyeball, and examine erythema or swelling over upper eyelid and facial skin after the intervention. The scale ranges from 1 to 3, with score 1 indicating no discomfort at all, score 2 moderate discomfort, and score 3 extremely discomfort.
次要结局
未报告次要终点
研究者
Lien, Ching-Feng
Deputy head of the Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital
E-DA Hospital