Status:
SUSPENDED
A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos
Lead Sponsor:
E-DA Hospital
Collaborating Sponsors:
National Yang Ming Chiao Tung University
The Industrial Technology Research Institute
Conditions:
Paralytic Lagophthalmos
Eligibility:
All Genders
18-85 years
Phase:
NA
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 cl...
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 pe...
Eligibility Criteria
Inclusion
- Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03848260
Start Date
August 1 2026
End Date
December 31 2027
Last Update
August 14 2025
Active Locations (1)
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1
E-DA Hospital
Kaohsiung City, Taiwan, 82445