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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03848260
Study type Interventional
Source E-DA Hospital
Contact
Status Suspended
Phase N/A
Start date May 1, 2025
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT04944498 - Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients N/A
Recruiting NCT06291818 - Self-Adhering Magnetic Device to Treat Corneal Exposure N/A