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

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

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.

Study Overview

• Status: Suspended
• Conditions: Paralytic Lagophthalmos
• Intervention / Treatment: Device: Magnetic device prototype

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 82445
    • E-DA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)
• Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
• Children younger than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Determine device feasibility; by evaluating efficacy and safety of the device prototype. Test the device one time (duration: 60-120 mins/each time) and second time within 12 months. Intervention: using the magnetic device prototype

Device: Magnetic device prototype; 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.

What is the study measuring?

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.	10 minutes after completion of the second testing within 12 months
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 second testing within 12 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.	10 minutes after completion of the second testing within 12 months

Collaborators and Investigators

• Sponsor: E-DA Hospital
• Collaborators: National Yang Ming Chiao Tung University; I-Shou University; The Industrial Technology Research Institute
• Investigators: Study Chair: Yuan-Kun Tu, MD, E-Da Hospital, Kaohsiung, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 9, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Facial nerve palsy; Lagophthalmos; Incomplete eye closure; Magnetic device; Blink restoration
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Eye Manifestations; Lagophthalmos
• Other Study ID Numbers: EMRP33106N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No