NCT03848260

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: E-DA Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paralytic Lagophthalmos

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-08-01
• Completion: 2027-12-31
• First posted: 2019-02-20
• Last updated: 2025-08-14

Locations

1 site across 1 country: Taiwan