跳至主要内容
临床试验/NCT03812016
NCT03812016招募中不适用

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

E-DA Hospital3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
3
主要终点
Evaluate the efficacy by measuring changes in distance.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Evaluate the efficacy by measuring changes in distance.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

  • Evaluate the efficacy by measuring changes in distance 1 month and 6 months after surgical intervention.(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.(1 month and 6 months after surgical intervention)

研究者

发起方
E-DA Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lien, Ching-Feng

Deputy head of the Department of Otolaryngology-Head and Neck Surgery, E-Da Hospital

E-DA Hospital

研究点 (3)

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