Management of Blepharoptosis with Neodymium Magnet Systems: The Boston Blink-netic Project

使用钕磁铁系统治疗上睑下垂：波士顿 Blink-netic 项目

• 批准号: 10385085
• 负责人: Kevin Edward Houston
• 金额: $ 9.58万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385085
• 关键词: 3-Dimensional; Address; Adhesions; Blepharoptosis; Blinking; Boston; Brain Stem Infarctions; Clinical; Clinical Trials; Collaborations; Craniocerebral Trauma; Crutches; Custom; Development; Devices; Diplopia; Eye; Eyelid structure; Facial Muscles; Head; Lead; Magnetism; Mechanics; Medical; Methods; Myasthenia Gravis; Neodymium; Neuromuscular Diseases; Paralysed; Patients; Positioning Attribute; Printing; Property; Prosthesis; Ptosis; Recovery; Safety; Scanning; Silicones; System; Thinness; Translating; experimental study; improved; novel; ocular surface; post stroke; prototype; tool

Project Summary / Abstract This project will complete the development of a promising novel magnetic eyewear device for non-surgical treatment of ptosis (paralysis of eye opening) followed by a clinical trial in patients. There are many causes of ptosis, but it is most severe and disabling after brainstem stroke, severe head trauma, and in Myasthenia Gravis (a neuro-muscular disorder often causing droopy lids and double vision). An effective non-surgical and easily adjustable treatment is essential in the early recovery period after stroke and head trauma, and in Myasthenia Gravis where the condition varies throughout the day. Available non-surgical treatments such as taping the eye open and a wire on the glasses to mechanically elevate the lid (ptosis crutch) are not very effective because they open the eye but do not allow full eye closure, resulting in discomfort and drying of the ocular surface. The novel magnetic device we are developing (the magnetic levator prosthesis) consists of 3 small magnets embedded in silicone (PDMS) attached to the lid with thin medical tape and a larger magnet above the eye on the upper eyewire of the glasses. The static magnetic force elevates the lid and the facial muscles of eye closure can overcome the magnetic force, re-animating the eyelid. Prior to clinical trials we aim to improve the MLP by developing a method allowing the patient to adjust the magnetic force using a dial on the frame, address the need for proper and consistent positioning of the frame utilizing available 3-D head scanning and printing (custom frame for each patient), improve the adhesion properties of the lid magnets through collaboration with a bioadhesives expert, and improve the ability of the patient to self-apply the lid magnets through the development of an applicator tool. An effective non-surgical approach for these patients is long overdue and the development and clinical trial aims of this proposal would lead to a device which can be directly translated for clinical use.

项目总结/摘要 该项目将完成一种有前途的新型非手术磁性眼镜设备的开发 治疗上睑下垂（睁眼麻痹），然后在患者中进行临床试验。的原因很多 上睑下垂，但在脑干中风、严重头部创伤和肌无力后最为严重和致残 重症（一种神经肌肉疾病，常导致眼睑下垂和复视）。一种有效的非手术和 在中风和头部创伤后的早期恢复期， 重症肌无力的情况在一天中变化。可用的非手术治疗，如 用胶带把眼睛睁开，在眼镜上用金属丝机械地抬高眼睑（上睑下垂拐杖）， 有效，因为它们可以睁开眼睛，但不允许完全闭眼，导致不适和眼睛干燥 眼表我们正在开发的新型磁性装置（磁性提肌假体）由3个 一个小磁铁嵌入硅胶（PDMS），用薄医用胶带和一个大磁铁固定在盖子上 在眼睛上方的眼镜上眼线上。静磁力将眼睑和面部 闭上眼睛的肌肉可以克服磁力，使眼睑恢复活力。在临床试验之前，我们的目标是 通过开发一种允许患者使用表盘调节磁力的方法来改善MLP， 该框架，解决了利用可用的3-D头部对框架进行适当和一致定位的需要 扫描和打印（为每位患者定制框架），改善盖磁体的粘附性能 通过与生物粘合剂专家的合作，提高患者自我应用盖子的能力 磁铁通过一个应用程序工具的发展。对这些患者有效的非手术方法是 该提案的开发和临床试验目标将导致一种设备， 直接翻译用于临床。