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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-01

Study Completion Date

2027-12-31

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.

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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.

Conditions

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Paralytic Lagophthalmos

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Magnetic device prototype

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No