Clinical trial NCT03848260: A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos
Official title: A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Paralytic Lagophthalmos
Keywords: Lagophthalmos
Incomplete eye closure
Magnetic device
Blink restoration
Facial nerve palsy
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
Collaborators: name: National Yang Ming Chiao Tung University
name: The Industrial Technology Research Institute
First posted: 2019-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
* Aged 18 years old or older

Exclusion Criteria:

* Upper eyelid scar, contracture, fibrosis, and atrophy due to previous surgical intervention(s) or traffic accident
* Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
* Children younger than 18 years of age

Primary outcomes:
measure: Changes in palpebral gap from the baseline.
timeFrame: 10 minutes after completion of the testing
measure: Changes in visual acuity (blurred vision) from the baseline.
timeFrame: 10 minutes after completion of the testing
measure: Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.
timeFrame: 10 minutes after completion of the testing
measure: Changes in palpebral gap from the baseline.
timeFrame: 10 minutes after completion of the second testing within 12 months
measure: Changes in visual acuity (blurred vision) from the baseline.
timeFrame: 10 minutes after completion of the second testing within 12 months
measure: Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.
timeFrame: 10 minutes after completion of the second testing within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
Study officials:
affiliation: E-Da Hospital, Kaohsiung, Taiwan
name: Yuan-Kun Tu, MD
role: STUDY_CHAIR
References: