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

Paralytic Lagophthalmos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03848260
• Other study ID #: EMRP33106N
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2025
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 12
• Est. completion date: December 31, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lagophthalmos
• Paralytic Lagophthalmos

Intervention

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.

Locations

Country	Name	City	State
Taiwan	E-DA Hospital	Kaohsiung

Sponsors (3)

Lead Sponsor	Collaborator
E-DA Hospital	National Yang Ming Chiao Tung University, The Industrial Technology Research Institute

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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