Principal Investigator/Program Director: Houston, Kevin, E. 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.

Public Health Relevance

Principal Investigator(s): Houston, Kevin, E. Project Narrative There are no effective non-surgical treatments for Blepharoptosis (ptosis, paralysis of eye opening). We developed a prototype magnetic device which was able to re-animate the blink. In this study we will perform experiments to improve the device followed by clinical trials to assess the safety, efficacy, and clinical feasibility.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project (R01)
Project #
5R01EY029437-02
Application #
9784848
Study Section
Bioengineering of Neuroscience, Vision and Low Vision Technologies Study Section (BNVT)
Program Officer
Mckie, George Ann
Project Start
2018-09-30
Project End
2023-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Massachusetts Eye and Ear Infirmary
Department
Type
DUNS #
073825945
City
Boston
State
MA
Country
United States
Zip Code
02114