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

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ClinicalTrials.gov Identifier: NCT03848260
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Paralytic Lagophthalmos Device: Magnetic device prototype Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : October 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Determine device feasibility

by evaluating efficacy and safety of the device prototype. Test the device one time (duration: 30-120 mins/each time) and 3 times within 3 months.

Intervention: using the magnetic device prototype

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.




Primary Outcome Measures :
  1. Changes in palpebral gap from the baseline. [ Time Frame: 10 minutes after completion of the testing ]
    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.

  2. Changes in visual acuity (blurred vision) from the baseline. [ Time Frame: 10 minutes after completion of the testing ]
    Assess visual acuity by Snellen test before and after the intervention.

  3. Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale. [ Time Frame: 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)

  4. Changes in palpebral gap from the baseline. [ Time Frame: 3-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.

  5. Changes in visual acuity (blurred vision) from the baseline. [ Time Frame: 3-months ]
    Assess visual acuity by Snellen test before and after the intervention.

  6. Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale. [ Time Frame: 3-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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848260


Contacts
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Contact: Ching-Feng Lien, MD 886-7-6150011 ext 5678 lien980206@yahoo.com.tw

Locations
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Taiwan
E-DA Hospital Recruiting
Kaohsiung, Taiwan, 82445
Contact: Ching-Feng Lien, MD    886-7-6150011 ext 5678    lien980206@yahoo.com.tw   
Sponsors and Collaborators
E-DA Hospital
Investigators
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Study Chair: Yuan-Kun Tu, MD E-Da Hospital, Kaohsiung, Taiwan

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Responsible Party: E-DA Hospital
ClinicalTrials.gov Identifier: NCT03848260     History of Changes
Other Study ID Numbers: EMRP33106N
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by E-DA Hospital:
Lagophthalmos
Incomplete eye closure
Magnetic device
Blink restoration
Facial nerve palsy