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

NCT03848260 | Suspended

• 1 other identifier: EMRP33106N
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Paralytic Lagophthalmos

Keywords

Lagophthalmos; Incomplete eye closure; Magnetic device; Blink restoration; Facial nerve palsy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Determine device feasibility

EXPERIMENTAL

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

Interventions

Magnetic device prototype DEVICE

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.

Determine device feasibility

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead
• National Yang Ming Chiao Tung University: collaborator
• The Industrial Technology Research Institute: collaborator
• I-Shou University: collaborator

Study Sites (1)

E-DA Hospital

Kaohsiung City, 82445, Taiwan

Location

MeSH Terms

Conditions

Lagophthalmos; Bell Palsy

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Eyelid Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Yuan-Kun Tu, MD

  E-Da Hospital, Kaohsiung, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy head of the Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 20, 2019
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)