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

E-DA Hospital

Status: Suspended

Conditions: Paralytic Lagophthalmos

Treatments: Device: Magnetic device prototype

Study type: Interventional

Funder types: Other

Identifiers

NCT03848260

EMRP33106N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Determine device feasibility

Experimental group

Description:

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

Treatment:

Device: Magnetic device prototype