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Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
Condition(s) studied
Bell's PalsyRamsay Hunt SyndromeLyme DiseaseFacial Palsy
Investigational drug(s) / intervention(s)
BlinkER device.
BlinkER device.: Participants will use the BlinkER System for 8-16 hours daily (removed during sleep) at approximately 10 blinks/minute. The stimulation cycle will be ON and OFF to achieve the desired blink rate. Participants will receive training on device usage before starting the study.
Study summary
Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.
Eligibility
Inclusion Criteria:
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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center. — 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
Trial sites (1)
| Facility | City | Region | Status |
| Rand Eye Institute |
Deerfield Beach |
Florida |
|
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