Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

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

Conditions
-----------------
Stroke, Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia

Intervention / Treatment
-----------------
* Device: Magnetic Levator Prosthesis (MLP)
* Device: Kinesiotape Frontalis Sling (KTFS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles) Moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam (MMSE) Exclusion Criteria: Absence of ptosis which occludes the visual axis Presence of a corneal ulcer of any size Age less than 5 years Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. Presence of corneal hypoaesthesia; Orbicularis weakness on the side of the ptosis Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos. Previous ptosis surgery less than 3 months prior to Visit 1. Lid position affected by lid or conjunctival scarring. History of herpes keratitis. Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the side of the ptosis within 3 months prior to Visit 1 and during the study. History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MLP first, KTFS second<br>Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period. | Device: Magnetic Levator Prosthesis (MLP)<br>* 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.<br>Device: Kinesiotape Frontalis Sling (KTFS)<br>* 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.<br>|
| Experimental: KTFS first, MLP second<br>Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period. | Device: Magnetic Levator Prosthesis (MLP)<br>* 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.<br>Device: Kinesiotape Frontalis Sling (KTFS)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between MLP and KTFS in the change in interpalpebral fissure during opening and spontaneous blinking | Measurements of the interpalpebral fissure will be taken from video recordings of eye lid opening and closing when using each of the devices | Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between MLP and KTFS in the changes in interpalpebral fissure during volitional blinking | Measurements of the interpalpebral fissure will be taken from video recordings of volitional eye lid closing when using each of the devices | Evaluated at baseline and then after being fitted with each device (immediately after, 20 minutes after and 1 week after) | 
| Proportion of subjects selecting each device | Proportion of subjects selecting either the MLP, the KTFS or neither | At the end of the one-week period of home use of the second device |