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The purpose of the experimental group is to test the intervention. Participants will have their acuity measured (refraction as needed), slit lamp with Nafl \& NEI scale, visual functioning questionnaire (VFQ), cognitive assessment (MOCA).The eye lid will be prepped and video recorded.The masked clinical staff will then apply the polarized magnets and perform a number of measurements to ascertain effectiveness of intervention.

-Intervention - Magnetic Levator Prosthesis (MLP)

The purpose of the normal vision group is to test the experimental setup prior to enrolling ptosis patients. If the measurements of the normal vision group are found to be non-different to the experimental group, the data will be pooled.

-Intervention - Magnetic Levator Prosthesis (MLP)

Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin. Tegaderm, which is essentially the same adhesive, is even FDA approved as an eye covering (we used Tegaderm in early studies but switched to IV 3000 for its superior ease of handling based on packaging technique).

Magnetic Levator Prosthesis (MLP)

Kevin Houston, OD, M. Sc.

Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device could restore eyelid movement. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device that could restore eyelid movement.

Blepharoptosis (incomplete opening of the eyelids) occurs because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. An external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force (Conway, 1973; Barmettler et. al, 2014; Houston et. al, 2014). Despite this seemingly straight-forward application, permanent magnets for eyelid movement disorders have not thus far become an available treatment. It is possible that earlier magnetic materials lacked the strength (at sizes which were acceptable to patients) to effectively restore the blink, or methods of implantation or external mounting were not effective. A newer class of permanent magnets made of alloys of neodymium (Nd), iron (Fe) and boron (B) might provide the technology needed to develop a feasible external magnetic device. They generate the strongest static magnetic fields yet possible, (1.3T compared to 0.4T of conventional ferrite magnets) (Cyrot, 2005) with exceptional uniaxial magnetocrystalline anisotropy, which makes them resistive to demagnetization (Chikazumui, 1997). The increased magnetic force at a fraction of the size has led to attempts for other medical applications including implantation for gastroesophageal reflux disease (Ganz, 2013), in dental prosthetics (Uribe, 2006), ocular reconstructive surgery (de Negreiros, 2012), and glaucoma (Paschalis et. al, 2013). Problems with extended external non-surgical adhesion to the skin of the eyelid may be solved with hydrocolloid-based medical adhesives e.g. Tegaderm™ (Chen, 1997), already used for IV catheter securement, wound dressing, and as a protective eye covering (FDA, 1997). This material is extremely thin, transparent, and oxygen permeable with an established safety profile for days to weeks of wear. The hydrophyllic properties (FDA, 1997) may be beneficial to the eyelids, which are often moist. In our prior work we established proof-of-concept data demonstrating safety and efficacy for temporary management ptosis up to 2 hour per day for 2 weeks. Due to the sensitive force distance relationship characteristics of magnetic fields and variable nature of ptosis (often worsens throughout the day) the MLP required frequent readjustment and consistent correction was difficult to achieve. Other challenges included lid redness with longer wear times (in the participants who wore the MLP longer than instructed), incomplete spontaneous blinking, and difficultly with self-application of the magnetic lid array to the eye lid. This study aims to address these challenges. In order to improve the MLP we will determine the range of force in the target severe ptosis population to open the lid and where blinking is inhibited, determine the best polarity combination between the lid magnets and the spectacle magnet, determine if rotating the spectacle magnet is a good method to allow simple force adjustment via a dial on the side of the frame, determine if custom made frames improve stability of the frame, and create an applicator tool to help participants apply the lid magnet themselves.

This is a prospective cross-over study with some aims having double-blind methodology. Randomization and masking will be used in aims 1 and 2 experiments. Aim 1: The spectacle magnet will be rotated to 1 of 4 settings in an order which will be counterbalanced using a Latin Square approach. Patient and experimenters will be masked to the actual force setting. Aim 2: 17 participants were randomized to be fitted first with either through thickness or through height polarization of the lid magnets using an online randomizer by a study staff not involved in the data collection or analysis who will keep the code. Every other subject in the sequence will be balanced to receive the alternative order. Counterbalancing is being used because of the small sample size.

Masked/blinded clinical staff will apply the lid magnets polarized either through thickness or through height (counterbalanced) to the study subjects. Also, 10 magnets of different sizes will be placed inside a plastic housing in order to prevent bias (participant and clinical staff will not know the actual size of the magnets) and counterbalance to control for order effect.

Clinical Trial to Improve the Magnetic Levator Prosthesis

Clinical Trial to Improve the Magnetic Levator Prosthesis (MLP) Including the Development and Testing of a Novel Adjustable Force System

A \> 1mm change in interpalpebral fissure (resting open) at min and max force of the rotatable system; a \>1mm change in interpalpebral fissure when the lid array is polarized through thickness as compared to through height.

Video analysis to measure the completeness of eye closure with the MLP compared to 1) no device, 2) relative to the contralateral side (if normal), 3) relative to different configurations of the device and custom vs. non-custom frames.

Massachusetts Eye and Ear Infirmary

Assistant Professor of Ophthalmology

Musculoskeletal Diseases

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Ophthalmoplegia

Ophthalmoplegia, Chronic Progressive External

Ocular Motility Disorders

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Paralysis

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Oculocerebral Syndrome With Hypopigmentation

Chronic Progressive External Ophthalmoplegia

Ocular Muscular Dystrophy

Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.

Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.

Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin.

Kineso Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational therapist to support muscular healing and movement. It is sometimes used on the face in cases of facial palsy or on the eye lid to support the lid in cases of severe blepharoptosis. In such cases it may be attached near the lid margin above the lashes extending up to the forehead skin overlying the frontalis muscle. Alternatively it may be a very short piece attached only along the lid skin. The tape is easily removed.

Kinesiotape Frontalis Sling (KTFS)

Kevin Houston, OD MSc

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of alloys of neodymium (Nd), iron (Fe) and boron (B)) to restore eyelid movement. The Kinesiotape Frontalis Sling (KTFS), involves the use of tape to help facilitate levator muscle contraction to open the eyelid. Video recordings of spontaneous and volitional blinks will be used to evaluate the effects of each device on eyelid reanimation.

The clinical trial will employ a crossover design in which participants will try each device at home in counterbalanced order with a washout period between. In each period of the crossover, participants will receive training (during study visits at Massachusetts Eye and Ear) in how to apply the device and will then try the device at home for one week with daily follow up by video calls. At the end of the one-week period of home use there will be a study visit at Massachusetts Eye and Ear when the device will be returned and additional video recordings of eye blinks will be made.

At the end of the crossover period, participants will be asked to complete a questionnaire comparing the two devices and to select their preferred device. If considered clinically appropriate, participants may be invited to continue using the preferred device for an additional two months with weekly follow ups to provide information about longer-term use of the intervention. Participants who are still using one of the devices at the end of the two months will be returned to clinical care and receive a study follow up (telephone call) after another 6 and 12 months.

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices

Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices

Proportion of subjects selecting either the MLP, the KTFS or neither

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial to Improve the Magnetic Levator Prosthesis	NCT03818204	Blepharoptosis Ptosis, Eyelid Myasthenia Grav... Stroke Traumatic Brain...	Magnetic Levato...	4 Years -	Massachusetts Eye and Ear Infirmary
Clinical Trial to Improve the Magnetic Levator Prosthesis	NCT03818204	Blepharoptosis Ptosis, Eyelid Myasthenia Grav... Stroke Traumatic Brain...	Magnetic Levato...	4 Years -	Massachusetts Eye and Ear Infirmary
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis	NCT04678115	Blepharoptosis Ptosis, Eyelid Myasthenia Grav... Stroke Traumatic Brain... Chronic Progres...	Magnetic Levato... Kinesiotape Fro...	5 Years -	Massachusetts Eye and Ear Infirmary
Clinical Trial to Improve the Magnetic Levator Prosthesis	NCT03818204	Blepharoptosis Ptosis, Eyelid Myasthenia Grav... Stroke Traumatic Brain...	Magnetic Levato...	4 Years -	Massachusetts Eye and Ear Infirmary

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