A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos

Conditions
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Paralytic Lagophthalmos

Intervention / Treatment
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* Device: Magnetic device prototype


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Determine device feasibility<br>by evaluating efficacy and safety of the device prototype. Test the device one time (duration: 30-120 mins/each time) and 3 times within 3 months. Intervention: using the magnetic device prototype | Device: Magnetic device prototype<br>* The device prototype comprises a near-infrared 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. The efficacy and safety of the device prototype was assessed using the device prototype.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in palpebral gap from the baseline. | 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. | 10 minutes after completion of the testing | 
| Changes in visual acuity (blurred vision) from the baseline. | Assess visual acuity by Snellen test before and after the intervention. | 10 minutes after completion of the testing | 
| Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale. | 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) | 10 minutes after completion of the testing | 
| Changes in palpebral gap from the baseline. | 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. | 3-months | 
| Changes in visual acuity (blurred vision) from the baseline. | Assess visual acuity by Snellen test before and after the intervention. | 3-months | 
| Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale. | 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. | 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lagophthalmos, Incomplete eye closure, Magnetic device, Blink restoration, Facial nerve palsy