Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy (NCT06542289) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy
United States80 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range22 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Cancer…
What they're measuring
1
The percent of participants who achieve eyelid closure graded by independent, masked graders at a reading center.