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

NCT03848260 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Paralytic Lagophthalmos

Interventions

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.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    collaborator OTHER

  • The Industrial Technology Research Institute

    collaborator OTHER

  • I-Shou University

    collaborator OTHER

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Yuan-Kun Tu, MD · E-Da Hospital, Kaohsiung, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848260 on ClinicalTrials.gov