BlepharoptosisNCT03812016
A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
A study testing Feedback-enabled magnetic device in people with Blepharoptosis and Device Usability, run by E-DA Hospital at 2 sites in Taiwan.
Trial summary
To develop a feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blepharoptosis, Device Usability
- What is being tested?
- Feedback-enabled magnetic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Apr 2023to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with ptosis; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Who cannot join
- Upper eyelid scar, contracture, or fibrosis 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
E-Da Hospital
Kaohsiung City, 82445
Ching-Feng Lien, MD, PhD, 886-975106033, lien980206@yahoo.com.tw
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Jiann-Horng Yeh, MD, 886-228332211 ext. 2071, m001074@ms.skh.org.tw
About this study
Official title: Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
To develop a feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human trial on patients with blepharoptosis.
Read the detailed description
The feedback-enabled magnetic device primarily comprises 2 matched pairs of one near-infrared light-emitting diode and one photodiode sensor, a magnetic actuator, an iron sheet (for affixing to the paralytic upper eyelid), and a biosignal acquisition module along with a power supply unit providing a wired connection with optical sensors and a magnetic actuator. Before the study, the differences between the affected and unaffected palpebral fissure heights were directly measured using a ruler. During the test after using the device, the distance of the paralytic eyelid lift was documented and the corrected distance (gain) of the paralytic upper eyelid was calculated. The efficacy and safety of the device were assessed. The efficacy was evaluated according to the symmetrical blinks and gain of paralytic eyelid lifts. Subjective sensation and complications were assessed by visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid. After the completion of the study procedure, the eyelid skin integrity, subjective sensation and discomfort were examined. Outcomes in the management of blepharoptosis of diverse etiologies using a feedback-enabled magnetic device will be demonstrated. Differences in outcomes between patients managed using the device and those who underwent surgery will be presented.
- Conditions
- Blepharoptosis, Device Usability
- Being tested
- Feedback-enabled magnetic device
- Keywords
- Blepharoptosis, Blink restoration, Magnetic device, Oculomotor nerve palsy, Ptosis
- Medical subject headings
- Blepharoptosis, Oculomotor Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback-enabled magnetic deviceDevice
The device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode and one sensor, a magnetic actuator, an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the feedback-enabled magnetic device.
| Study group | Role | What they receive |
|---|---|---|
| Determine device feasibility | Experimental | by evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device. Receives: Device: Feedback-enabled magnetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy by measuring changes in distance.
The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction before any intervention and during the device intervention by a ruler and a software.
Measured: 10-minutes after completion of the device testing.
Evaluate visual field changes and discomfort of blurred vision, cornea, upper eyelid, and skin before and after the device use based on a 3-point Likert scale.
The investigators score questionnaires by assessing visual field changes and discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after device use. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating no discomfort, score 2 mild to moderate discomfort, and score 1 severe discomfort.
Measured: 10-minutes after completion of the device testing
Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation.
The investigators assess electrical activities of the frontalis muscle and calculate total electromyographic areas (sum of all areas under the curve) before and after the device intervention.
Measured: 10-minutes after completion of the testing
Secondary outcomes (2)
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.
The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction after surgical intervention (performed after completion of the device intervention) by a ruler and a software.
Measured: 1 month and 6 months after completion of surgical intervention.
Evaluate visual field changes and complications 1 month and 6 months after surgical intervention based on a 3-point Likert scale.
The investigators score questionnaires by assessing visual field changes and complications (including cosmetic results, headache relief, undercorrection, infection, foreign body tissue reaction, lagophthalmos, and keratitis). For visual field changes based on the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating good outcomes, score 2 fair outcomes, and score 1 poor outcomes; for complications, with score 3 indicating no discomfort (satisfied), score 2 mild to moderate discomfort (somewhat satisfied), and score 1 severe discomfort (dissatisfied).
Measured: 1 month and 6 months after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharoptosisStudies 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
- 40 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, Shin Kong Wu Ho-Su Memorial Hospital, National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Lien, Ching-Feng, E-DA Hospital
- Investigators
- Yuan-Kun Tu, Study chair, E-Da Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812016
- Sponsor's protocol ID
- EDAHP107026
- Status last verified
- May 2026
- First submitted
- 17 Jan 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lien CF, Lin BS, Wu TM, Lin YC, Chang RC, Cheng CK, Yeh JH, Jeng SF. Efficacy and Safety of a Magnetic Device for Temporary Management of Blepharoptosis: Single-Arm Open-Label Trial. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1111-1120. doi: 10.1002/ohn.1350. Epub 2025 Jul 16.
PubMed 40671431
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
- ClinicalTrials.gov ID
- NCT03812016
- Acronym / sponsor ID
- EDAHP107026
- Conditions
- Blepharoptosis, Device Usability
- Keywords
- Blepharoptosis, Blink restoration, Magnetic device, Oculomotor nerve palsy, Ptosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, The Industrial Technology Research Institute, Shin Kong Wu Ho-Su Memorial Hospital, National Science and Technology Council, Taiwan
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 22 Jan 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 feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human trial on patients with blepharoptosis.
Detailed description
The feedback-enabled magnetic device primarily comprises 2 matched pairs of one near-infrared light-emitting diode and one photodiode sensor, a magnetic actuator, an iron sheet (for affixing to the paralytic upper eyelid), and a biosignal acquisition module along with a power supply unit providing a wired connection with optical sensors and a magnetic actuator. Before the study, the differences between the affected and unaffected palpebral fissure heights were directly measured using a ruler. During the test after using the device, the distance of the paralytic eyelid lift was documented and the corrected distance (gain) of the paralytic upper eyelid was calculated. The efficacy and safety of the device were assessed. The efficacy was evaluated according to the symmetrical blinks and gain of paralytic eyelid lifts. Subjective sensation and complications were assessed by visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid. After the completion of the study procedure, the eyelid skin integrity, subjective sensation and discomfort were examined. Outcomes in the management of blepharoptosis of diverse etiologies using a feedback-enabled magnetic device will be demonstrated. Differences in outcomes between patients managed using the device and those who underwent surgery will be presented.
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: Feedback-enabled magnetic deviceby evaluating efficacy and safety of the device. Test the device (duration: 120 mins/each time). Intervention: using the feedback-enabled magnetic device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ptosis; 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, or fibrosis 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 |
|---|---|---|
| Feedback-enabled magnetic deviceThe device comprises 1 or 2 matched pairs of one near-infrared light-emitting diode and one sensor, a magnetic actuator, an iron sheet, and a biosignal acquisition module. The efficacy and safety were assessed using the feedback-enabled magnetic device. | Device | Determine device feasibility |
Primary outcome
Evaluate the efficacy by measuring changes in distance.
Time frame: 10-minutes after completion of the device testing.
The investigators assess changes (in millimeter) of palpebral fissure height and visual field obstruction before any intervention and during the device intervention by a ruler and a software.
Evaluate visual field changes and discomfort of blurred vision, cornea, upper eyelid, and skin before and after the device use based on a 3-point Likert scale.
Time frame: 10-minutes after completion of the device testing
The investigators score questionnaires by assessing visual field changes and discomfort of blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid after device use. According to concepts from the 3-point Likert scale, the scale ranges from 1 to 3 with score 3 indicating no discomfort, score 2 mild to moderate discomfort, and score 1 severe discomfort.
Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation.
Time frame: 10-minutes after completion of the testing
The investigators assess electrical activities of the frontalis muscle and calculate total electromyographic areas (sum of all areas under the curve) before and after the device intervention.
2 secondary outcomes
Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.
Time frame: 1 month and 6 months after completion of surgical intervention.
Evaluate visual field changes and complications 1 month and 6 months after surgical intervention based on a 3-point Likert scale.
Time frame: 1 month and 6 months after surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 40671431Lien CF, Lin BS, Wu TM, Lin YC, Chang RC, Cheng CK, Yeh JH, Jeng SF. Efficacy and Safety of a Magnetic Device for Temporary Management of Blepharoptosis: Single-Arm Open-Label Trial. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1111-1120. doi: 10.1002/ohn.1350. Epub 2025 Jul 16.
- 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.
Yuan-Kun Tu study chair
E-Da Hospital, Kaohsiung, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback-enabled magnetic device in people with Blepharoptosis and Device Usability, run by E-DA Hospital at 2 sites 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Feng Lien, MD, PhD (886-975106033, lien980206@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy by measuring changes in distance. (time frame: 10-minutes after completion of the device testing.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812016, which also lists 1 linked publication.
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 23 Sep 2026.