Paralytic LagophthalmosNCT03848260
A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos
A study testing Magnetic device prototype in people with Paralytic Lagophthalmos, run by E-DA Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Paralytic Lagophthalmos
- What is being tested?
- Magnetic device prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos
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.
Read the 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.
- Conditions
- Paralytic Lagophthalmos
- Being tested
- Magnetic device prototype
- Keywords
- Lagophthalmos, Incomplete eye closure, Magnetic device, Blink restoration, Facial nerve palsy
- Medical subject headings
- Lagophthalmos, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic device prototypeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Determine device feasibility | Experimental | by evaluating efficacy and safety of the device prototype. Test the device one time (duration: 60-120 mins/each time) and second time within 12 months.
Intervention: using the magnetic device prototype Receives: Device: Magnetic device prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in palpebral gap from the baseline.
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.
Measured: 10 minutes after completion of the testing
Changes in visual acuity (blurred vision) from the baseline.
Assess visual acuity by Snellen test before and after the intervention.
Measured: 10 minutes after completion of the testing
Discomfort of the eyeball and condition of the upper eyelid and facial skin based on a dichotomous Likert scale.
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)
Measured: 10 minutes after completion of the testing
Changes in palpebral gap from the baseline.
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.
Measured: 10 minutes after completion of the second testing within 12 months
Changes in visual acuity (blurred vision) from the baseline.
Assess visual acuity by Snellen test before and after the intervention.
Measured: 10 minutes after completion of the second testing within 12 months
Discomfort of the eyeball and degree of the upper eyelid and facial skin based on a 3-point Likert scale.
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.
Measured: 10 minutes after completion of the second testing within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Although six patients completed the test using device prototype before Dec 2019, but due to the large size and shape, we failed to well miniaturize and manufacture a resilient system that stands the test of time for the future trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic LagophthalmosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, The Industrial Technology Research Institute, I-Shou University
- Responsible party
- Principal investigator, Lien, Ching-Feng, E-DA Hospital
- Investigators
- Yuan-Kun Tu, MD, Study chair, E-Da Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848260
- Sponsor's protocol ID
- EMRP33106N
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2019
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-Time Magnetic Device Prototype for Management of Paralytic Lagophthalmos
- ClinicalTrials.gov ID
- NCT03848260
- Acronym / sponsor ID
- EMRP33106N
- Conditions
- Paralytic Lagophthalmos
- Keywords
- Lagophthalmos, Incomplete eye closure, Magnetic device, Blink restoration, Facial nerve palsy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Although six patients completed the test using device prototype before Dec 2019, but due to the large size and shape, we failed to well miniaturize and manufacture a resilient system that stands the test of time for the future trial.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, The Industrial Technology Research Institute, I-Shou University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determine device feasibility | Experimental | Device: Magnetic device prototypeby evaluating efficacy and safety of the device prototype. Test the device one time (duration: 60-120 mins/each time) and second time within 12 months. Intervention: using the magnetic device prototype |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic device prototypeThe 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. | Device | Determine device feasibility |
Primary outcome
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.
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.
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)
Changes in palpebral gap from the baseline.
Time frame: 10 minutes after completion of the second testing within 12 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.
Time frame: 10 minutes after completion of the second testing within 12 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.
Time frame: 10 minutes after completion of the second testing within 12 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Kun Tu, MD study chair
E-Da Hospital, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic device prototype in people with Paralytic Lagophthalmos, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in palpebral gap from the baseline. (time frame: 10 minutes after completion of the testing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.