A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Changes in palpebral gap from the baseline. [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.
- Changes in visual acuity (blurred vision) from the baseline. [10 minutes after completion of the testing]
Assess visual acuity by Snellen test before and after the intervention.
- Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale. [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)
- Changes in palpebral gap from the baseline. [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.
- Changes in visual acuity (blurred vision) from the baseline. [3-months]
Assess visual acuity by Snellen test before and after the intervention.
- Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale. [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.
Eligibility Criteria
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
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Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
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Children younger than 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | E-DA Hospital | Kaohsiung | Taiwan | 82445 |
Sponsors and Collaborators
- E-DA Hospital
Investigators
- Study Chair: Yuan-Kun Tu, MD, E-Da Hospital, Kaohsiung, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMRP33106N