A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feedback-enabled magnetic device.
- Who it may be relevant to
- Registry conditions: Blepharoptosis, Device Usability. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device
Overview
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.
Interventions
- Device Feedback-enabled magnetic device
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.
Primary outcome measures
- Evaluate the efficacy by measuring changes in distance. [Time frame: 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. [Time frame: 10-minutes after completion of the device testing]
- Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation. [Time frame: 10-minutes after completion of the testing]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Patients with ptosis; they are capable of understanding and complying with protocol requirements
- Aged 18 years old or older
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 2 centers
- E-Da Hospital — Kaohsiung City
- Shin Kong Wu Ho-Su Memorial Hospital — Taipei
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. PMID 40671431
Identifiers
NCT: NCT03812016 · EDAHP107026