A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis

Официальное название

Comparison of Treatment Outcomes for Blepharoptosis of Various Etiologies Using a Feedback-enabled Magnetic Device

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Evaluate the efficacy by measuring changes in distance. [Срок оценки: 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. [Срок оценки: 10-minutes after completion of the device testing]
• Evaluate frontalis muscle use by measuring changes in muscle activities in both amplitude and fluctuation. [Срок оценки: 10-minutes after completion of the testing]

Вторичные конечные точки (2)

• Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention. [Срок оценки: 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. [Срок оценки: 1 month and 6 months after surgical intervention]

Критерии участия

Критерии включения

• Patients with ptosis; they are capable of understanding and complying with protocol requirements
• Aged 18 years old or older

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• E-Da Hospital — Kaohsiung City
• Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Публикации

• 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

Идентификаторы

NCT: NCT03812016 · EDAHP107026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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