Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
研究概览
简要总结
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
详细描述
A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure over a 3-month period in individuals with facial nerve palsy. The study aims to enroll at least 80 participants for evaluation. Participants will use the investigative device for a duration of 3 months.
All subjects will undergo the following visits: Screening/Baseline (Day 0), Day 1, Week 1, Week 2, Month 1, Month 2 (Remote visit), and Month 3.
The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma.
The estimated total study duration is 12 months.
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
盲法说明
Open-label study
入排标准
- 年龄范围
- 22 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older
- •Unilateral facial palsy due to any of the following: Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma
- •A deficit in eye closure during blinking, defined as a mean blink score ≤2.0 in the study eye on the scale by Mäkelä, et al, as graded by the investigator.
- •Willing and able to comply with the study procedures and follow-up
- •Willing and able to provide informed consent
- •English, Spanish, or Hebrew, Arabic -speaking
- •In a trial with the BlinkER System, the device produces blinks sufficient to cover the pupil in the study eye, defined as a mean grade ≥ 3.0 on the Mäkelä scale, as graded by the investigator.
- •Participant successfully completes BlinkER System training and certification
排除标准
- •Bilateral facial paralysis (for example Parkinson's Disease)
- •History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.)
- •Has an implanted eyelid weight in the study eyelid.
- •History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe cognitive or motor impairment, severe immunological deficiency, or malignant diseases that are not in remission
- •Signs of corneal infection, severe ocular surface inflammation, or significant periorbital skin inflammation/infection
- •Suspected or diagnosed epilepsy.
- •Cancerous lesions in the area where the BlinkER system electrodes will be applied.
- •Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- •Cornea or iris abnormalities that preclude visualization of the pupil
- •Cranial nerve V palsy or neurotrophic keratitis
- •Synkinesis that results in eyelid closure
- •Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel)
- •Participants who are pregnant or nursing.
- •Participation in another ophthalmic clinical trial within one year prior to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study.
- •Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the participant to the protocol.
结局指标
主要结局
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.
时间窗: 2 weeks
Eyelid closure is defined as a mean blink score as graded by the independent masked graders using the Mäkelä scale: 5- Complete eye closure 4- Nearly complete eye closure 3- Eyelid covers the pupil 2-Eyelid partially covers the pupil 1-Twitch 0- No movement
次要结局
- Percent of participants who achieve eyelid closure in the study eye at 3 months.(up to 3 months)
- Percent of participants who achieve eyelid closure in the study eye at 1 month.(up to 1 month)
- safety outcome is the rate of adverse events through 3 months.(3 months)