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

Not Applicable

Suspended

• Conditions: Paralytic Lagophthalmos
• Interventions: Device: Magnetic device prototype

• Registration Number: NCT03848260
• Lead Sponsor: E-DA Hospital

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.

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 Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-31
• Last Update Posted: 2024-04-02
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Determine device feasibility	Magnetic device prototype	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

Primary Outcome Measures

Name	Time	Method
Changes in palpebral gap from the baseline.	10 minutes after completion of the second testing within 12 months	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.
Changes in visual acuity (blurred vision) from the baseline.	10 minutes after completion of the second testing within 12 months	Assess visual acuity by Snellen test before and after the intervention.
Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.	10 minutes after completion of the testing	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)
Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.	10 minutes after completion of the second testing within 12 months	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.

Trial Locations

Locations (1)

E-DA Hospital; 🇨🇳 Kaohsiung, Taiwan