A Randomized Cross-Over Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Phase: NA
Conditions: Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke, Traumatic Brain Injury, Chronic Progressive External Ophthalmoplegia
Sponsor: Massachusetts Eye and Ear Infirmary

ii 
 
 
A single center sham and active controlled double blind randomized 
crossover trial of the magnetic levator prothesis for severe 
blepharoptosis  
 
ClinicalTrials.gov title: Clinical Trial Comparing Two Non-Surgical Treatments for 
Severe Blepharoptosis 
 
ClinicalTrials.gov ID number: NCT04678115 
Institutional IRB title: Clinical Trial to improve the magnetic levator prosthesis 
(MLP) including the development and testing of a novel adjustable force system 
and comparison to the Kinesio Tape frontalis sling (KTFS) 
Institutional IRB Protocol Identifying Number: 2019P003055 
 
Principal Investigators: Kevin E. Houston, OD, MSc, FAAO, Lotfi Merabet, OD, PhD  
Protocol contributors: Kevin E. Houston, OD, MSc, FAAO; Shrinivas Pundlik, PhD; Prerana 
Shivshanker, MPhil Optometry; Alex Bowers, MCOptom, PhD; Sara LaRosa, OT; Mara Robinson, 
PT; Patrick Lee, OD; Eleftherios I. Paschalis, PhD 
 
Draft or Version Number:  version 1 
Date: May 30, 2024,  
Funding:  NIH/NEI R01EY029437 
 
Disclosure:  
E.I. Paschalis and K.E. Houston are named on a US patent application assigned to Schepens Eye 
Research Institute for the technology that is the topic of this research. The institution has 
reviewed this potential conflict and the authors have followed any requirements for 
management. The IP is not currently licensed and the device is not commercially available. E.I. 
Paschalis is also a paid consultant for Strategic Intelligence Inc. but is not a conflict to this 
work.  

iii 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 
Page  
LIST OF ABBREVIATIONS 
1 
STATEMENT OF COMPLIANCE 
1 
PROTOCOL SUMMARY 
1 
SCHEMATIC OF STUDY DESIGN 
2 
1. KEY ROLES 
2 
2. INTRODUCTION: BACKGROUND 
INFORMATION AND SCIENTIFIC 
RATIONALE 
2 
2.1 Background information 
2 
2.2 Rationale 
4 
2.3 Potential Risks and Benefits 
5 
2.3.1 Known potential risks 
5 
2.3.2 known potential benefits  
6 
3. OBJECTIVES AND PURPOSE 
6 
4. STUDY DESIGN AND ENDPOINTS 
6 
4.1 Description of the Study Design 
6 
4.2.1 Primary endpoint 
6 
4.2.2 Secondary endpoints 
6 
4.2.3 Exploratory endpoints  
6 
5. STUDY ENROLLMENT AND WITHDRAWAL 
6 
5.1 Participant Inclusion Criteria 
7 
5.2 Participant Exclusion Criteria 
7 
5.3 Strategies for Recruitment and Retention 
7 
5.4 Participant Withdrawal or termination 
8 
5.4.1 Reasons for Withdrawal or Termination 
8 
5.4.2 Handling of Participant Withdrawals or 
termination 
8 
5.5 Premature Termination or Suspension of 
Study 
8 
6. STUDY AGENT 
8 
6.1 Study Agent(s) and Control Description 
9 
6.1.1 Acquisition 
9 

iv 
 
6.1.2 Formulation, Appearance, Packaging, and 
Labeling 
9 
6.1.3 Product Storage and Stability 
9 
6.1.4 Preparation 
9 
6.1.5 Dosing and Administration 
9 
6.1.6 Route of Administration 
9 
6.1.7 Starting Dose and Dose Escalation Schedule 
9 
6.1.8 Dose Adjustments/Modifications/Delays 
9 
6.1.9 Duration of Therapy 
9 
6.1.10 Tracking of Dose 
9 
6.1.11 Device Specific Considerations 
10 
6.2 Study agent Accountability Procedures 
10 
7. STUDY PROCEDURES AND SCHEDULE 
10 
7.1 Study Procedures/Evaluations 
10 
7.1.1 Study specific procedures 
10 
7.1.2 Standard of care study procedures 
11 
7.2 Laboratory Procedures/Evaluations 
11 
7.2.1 Clinical Laboratory Evaluations 
11 
7.2.2 Other Assays or Procedures 
11 
7.2.3 Specimen Preparation, Handling, and 
Storage 
11 
7.2.4 Specimen Shipment 
11 
7.3 Study Schedule 
11 
7.3.1 Screening 
11 
7.3.2 Enrollment/Baseline 
11 
7.3.3 Follow-up 
12 
7.3.4 Final Study Visit 
 
13 
7.3.5 Early Termination Visit 
13 
7.3.6 Schedule of Events Table 
13 
7.4 Justification for Sensitive Procedures 
14 
7.5 Concomitant Medications, Treatments, and 
Procedures 
14 
7.5.1 Precautionary Medications, Treatments, 
and Procedures 
14 
7.6 Prohibited Medications, Treatments, and 
Procedures 
14 
7.7 Prophylactic Medications, Treatments, and 
Procedures 
14 
7.8 Rescue Medications, Treatments, and 
Procedures 
14 
7.9 Participant Access to Study Agent At Study 
Closure 
14 
8. ASSESSMENT OF SAFETY 
15 
8.1 Specification of Safety Parameters 
15 
8.1.1 Definition of Adverse Events (AE) 
15 
8.1.2 Definition of Serious Adverse Events (SAE) 
15 

v 
 
8.1.3 Definition of Unanticipated Problems (UP) 
16 
8.2 Classification of an Adverse Event 
16 
8.2.1 Severity of Event 
16 
8.2.2 Relationship to Study Agent 
16 
8.2.3 Expectedness 
16 
8.3 Time Period and Frequency for Event 
Assessment and Follow-Up 
16 
8.4 Reporting Procedures 
16 
8.4.1 Adverse Event Reporting 
16 
8.4.2 Serious Adverse Event Reporting 
16 
8.4.3 Unanticipated Problem Reporting 
17 
8.4.4 Events of Special Interest 
17 
8.4.5 Reporting of Pregnancy 
17 
8.5 Study Halting Rules 
17 
8.6 Safety Oversight 
17 
9. CLINICAL MONITORING 
17 
10. STATISTICAL CONSIDERATIONS 
17 
10.1 Statistical and Analytical Plans 
17 
10.2 Statistical Hypotheses 
17 
10.3 Analysis Datasets 
17 
10.4 Description of Statistical Methods 
17 
10.4.1 General Approach 
17 
10.4.2 Analysis of the Primary Efficacy 
Endpoint(s) 
20 
10.4.3 Analysis of the Secondary Endpoint(s) 
21 
10.4.4 Safety Analyses 
21 
10.4.5 Adherence and Retention Analyses 
21 
10.4.6 Baseline Descriptive Statistics 
21 
10.4.7 Planned Interim Analyses 
21 
10.4.8 Multiple Comparison/Multiplicity 
22 
10.4.9 Tabulation of Individual Response Data 
22 
10.4.10 Exploratory Analyses 
22 
10.5 Sample Size 
22 
10.6 Measures to Minimize Bias 
22 
10.6.1 Enrollment/ Randomization/ Masking 
Procedures 
22 
10.6.2 Evaluation of Success of Blinding 
23 
10.6.3 Breaking the Study Blind/Participant Code 
23 
11. SOURCE DOCUMENTS AND ACCESS TO 
SOURCE DATA/DOCUMENTS 
24 
12. QUALITY ASSURANCE AND QUALITY 
CONTROL 
24 
13. ETHICS/PROTECTION OF HUMAN 
SUBJECTS 
24 
13.1 Ethical Standard 
24 
13.2 Institutional Review Board 
24 

vi 
 
13.3 Informed Consent Process 
24 
13.3.1 Consent/assent and Other Informational 
Documents Provided to Participants 
25 
13.3.2 Consent Procedures and Documentation 
25 
13.4 Participant and data Confidentiality 
26 
13.4.1 Research Use of Stored Human Samples, 
Specimens or Data 
26 
13.5 Future Use of Stored Specimens 
26 
14. DATA HANDLING AND RECORD KEEPING 
26 
14.1 Data Collection and Management 
Responsibilities 
26 
14.2 Study Records Retention 
26 
14.3 Protocol Deviations 
27 
14.4 Publication and Data Sharing Policy 
27 
15. STUDY ADMINISTRATION 
27 
15.1 Study Leadership 
27 
16. CONFLICT OF INTEREST POLICY 
27 
17. LITERATURE REFERENCES 
27 
 
 
 

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
1 
 
LIST OF ABBREVIATIONS 
 
MLP 
Magnetic levator prosthesis 
IPF 
Interpalpebral fissure 
PI 
Principal Investigator 
NEI 
National Eye Institute 
NAFL 
Sodium Fluorescein 
IRB 
Institutional Review Board 
MEEI 
Massachusetts Eye and Ear Infirmary 
HRPP 
Human Research Protections Program 
MMSE 
Mini Mental Status Exam 
KTFS 
Kinesio Tape frontalis sling  
aQoL 
Assessment of Quality of Life 
EQ-5D-5L 
Euro Quality of Life Questionnaire 
GBI-5F 
Glasgow Benefit Inventory 
 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with Good Clinical Practices, the U.S. Code of Federal Regulations 
on the Protection of Human Subjects (45 CFR Part 46), the Code of Federal Regulations applicable to 
clinical studies (21 CFR 312 – Investigational New Drug Application, 21 CFR 50 – Protection of Human 
Subjects and 21 CFR 54.  The Principal Investigator at the study site Massachusetts Eye and Ear Infirmary 
will assure that no deviation from, or changes to the protocol will take place without prior agreement 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the study participants. All personnel involved in the conduct of this study have 
completed Human Subjects Protection Training. 
 
PROTOCOL SUMMARY 
Title: 
A single center sham and active controlled double blind randomized crossover 
trial of the magnetic levator prothesis for severe blepharoptosis 
 
 
 
 
 
 
Outcome 
measures 
Primary outcome: Difference between MLP and KTFS in the change in 
interpalpebral fissure during and spontaneous blinking 
 
 
Secondary outcome: Difference between MLP and KTFS in the changes in 
interpalpebral fissure during opening and volitional blinking 
 
 
Secondary outcome: Proportion of subjects selecting each device at the end of 
the crossover 
 
 
 
Population: 
Individuals with severe unilateral or bilateral ptosis defined as occlusion of the 
visual axis by the lid in the resting state 
Phase: 
N/A 

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
2 
 
Number of Sites 
enrolling 
participants: 
1 
Description of 
Study Agent : 
Magnetic levator prosthesis (MLP) with compatible spectacle frames 
Kinesio Tape frontalis sling (KTFS) 
Study Duration: 
2 to 3 years 
Participant 
Duration: 
8 or 9 weeks from enrollment to the end of the crossover period of the clinical 
trial, with an additional 8 weeks after the end of the crossover for subjects who 
have a clinical decision to participate in the extended wear part of the clinical 
trial  
 
SCHEMATIC OF STUDY DESIGN 
Also, please refer to the study schema: 
 
FU: Follow up 
 
1 
KEY ROLES 
Principal Investigator – Overall responsibility for all study related activities.   
Co-investigator (clinical trial lead):  Responsibility for randomized crossover clinical trial management.  
Clinical Research Technicians- Responsible for consenting, enrolling and scheduling subjects. Also will 
collect, record and report all study data, and fit and train for the MLP device and the tape (KTFS) as a 
backup plan. 
Physical Therapy Advisor:  Training of clinical study staff and monitoring the quality of fitting for the KTFS. 
Engineering research fellow: Responsible for: Assembling MLP devices and maintaining device logs 
Independent safety monitor:  Examine participants with adverse events and review all safety outcome 
reports. 
 
2  
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
 
2.1 
Background Information  
Blepharoptosis, defined as incomplete opening of the upper eyelid, occurs due to abnormalities 
in the function or structure of the levator palpebrae superioris muscle, injury to or dysfunction of the 
superior division of the 3rd cranial nerve, or structural abnormalities.[1] Etiologies include congenital 
Determine 
eligibility and 
consent subject
Randomise
First period of 
crossover
Washout
Second period 
of crossover
Debrief and 
clinical decision 
whether to 
continue with 
preferred 
device
If want to 
continue:
Extended wear 
of preferred 
device + 6 & 12 
month FU 
phone calls 
Post 6 & 12 
month phone 
call to 
administer  ED-
5-5L & GBI-5L 
regardless of 
extended trial 
or not

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
3 
 
abnormalities, stroke, traumatic brain injury, tumors of the brain or face, viral illnesses, diabetes, 
autoimmune disorders such as myasthenia gravis, and general aging mechanisms.[1] The prevalence of 
blepharoptosis within the US general population is unknown; however, in Korean and U.K. general 
population it has been reported to be 11% [2, 3] suggesting 30 million people in the U.S. have the 
disorder. 
Severe ptosis and associated ophthalmoplegia cause low vision with negative effects on 
function and quality of life – Total bilateral ptosis causes profound yet potentially reversible visual 
impairment.  Associated ophthalmoplegia results in an inability to consistently utilize the fovea, and so in 
many cases magnification is useful.  In bilateral 3rd nerve palsy, for example, the eye is frequently 
permanently abducted 30° or more, so even if the lids are opened common low vision rehabilitation 
interventions are needed.  A similar but usually less severe situation exists in poorly controlled myasthenia 
gravis.  When ptosis is subtotal but severe, patients are symptomatic of constricted visual field reporting 
problems with mobility and inability to drive.  Inability to drive and effort of constant frontalis recruitment 
limits employability, making travel to work and sustained computer viewing very difficult.  Severe 
unilateral ptosis (CN III palsy) causes loss of binocular peripheral field (~30°), stereopsis, and binocular 
summation (which is often problematic at night or other dim environments).  All levels of ptosis have 
negative social and cosmetic impacts which are likely to affect employment and social well-being.   
Common surgical treatments - The most common method currently used to correct ptosis 
involves surgical tightening of the levator muscle, or in more severe cases, frontalis sling.[1]  While these 
procedures are a mainstay of treatment, in our experience they have disadvantages in that they do not 
always restore normal blink function and over-correction may result in exposure keratitis.  In severe cases 
of ptosis a conservative approach is needed leaving the ptosis under-corrected, and so even surgical 
candidates may benefit from magnetic correction.    
An effective easily adjustable and/or non-surgical treatment is needed - Substantially less 
attention has been given to non-surgical approaches for ptosis, which has led to lack of effective options 
during the early recovery period from neurological etiologies, in cases with daily variability in the ptosis 
such as Myasthenia Gravis, or other cases where surgery is contraindicated.  Ability for the patient to 
easily adjust the correction as the ptosis varies would be advantageous whether it were applied surgically 
or not.      
Limitations of available temporary treatments - We believe that available temporary or non-
surgical treatments are ineffective and even contraindicated for many target populations. These include 
taping the lid(s) open and propping the lid open with a wire on the glasses (ptosis crutch).[4]  
Unfortunately there is a paucity of data on safety or efficacy of the ptosis crutch or taping. The crutch has 
to be continually adjusted to keep the lid elevated, does not allow a complete blink,[5]  and poses a risk 
for ocular injury during adjustment or should the patient fall. We have frequently encountered use of skin 
tape to elevate the eye lid, but this has potentially damaging effects on the ocular surface from incomplete 
eye closure. A newly released eye drop (Upneeq, Osmotica/RVL, January 2021) has recently been 
approved for mild age-related ptosis (might be used off label for severe myo or neurogenic ptosis), but its 
effects are unknown for severe ptosis. 
Static magnets could provide force to elevate the eyelid while still allowing eye closure - In 
most types of ptosis, while opening of the eyelid is impaired, the neuromuscular complex for eye closure 
(Orbicularis oculi muscle/cranial nerve (CN) VII) is intact. [1]  In these cases the ptosis might be alleviated 
using a permanent static magnet system to provide the force to elevate the upper eyelid.[6]  The static 
force exerted by the permanent magnet to open the eyelid should be easily overcome by the Orbicularis 
Oculi muscle, assuming the force of the magnet is not too great, reanimating the blink.  This approach 
utilizes well-understood, widely available and inexpensive static magnetic materials.  Electromagnets 
might seem like an attractive option for the ability to modulate force; however, they generate heat and 
would consume too much energy to be feasible for continuous use.  We had also considered electrical 

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
4 
 
stimulation of the levator muscle; however, our mentors who have investigated the possibility of this 
approach previously indicated that repeated stimulation externally on the skin is painful in addition to 
difficulty accessing the levator non-surgically via this technique.      
Prior attempts to use magnets for ptosis - The concept of correcting ptosis with magnetic force 
was first presented in the 1970’s.[6]  Conway described attaching Mu-metal 13 x 4 x 0.5 mm to the upper 
lid in 3 patients (attached with eyelash adhesive or blenderm tape), and a small bar magnet to the 
spectacles.  Specifications of the ferrite spectacle magnet were not provided; however, we measured 
them in the photos to be ~20 x 5 x 10mm.  Conway’s photographs showed elevation of the eyelid when 
the lid and spectacle magnet were in contact; however, the ferrite magnet/Mu-metal would not have 
generated enough force to elevate the lid from the closed position, where there is typically 15 to 20mm 
separation.[5]  As a result the magnet glasses would have needed frequent adjustment to bring the 
materials back into direct contact after each blink offering no substantial benefit over the long available 
ptosis crutch.  It is therefore not surprising that the treatment was never commercialized.  Since Conway’s 
report, we find no publications on the use of magnets for ptosis, although they have been attempted for 
lagophthalmos via surgical implantation with only limited success.[7-10]  Problems related to surgical 
implantation highlight the benefit of first refining the approach non-surgically.  Static magnets are also 
better suited for ptosis as compared to lagophthalmos, because of the relative strength of the orbicularis 
compared to the levator.     
 
2.2 
Rationale  
We recently described a novel non-surgical magnetic eyewear device referred to as the 
Magnetic Levator Prosthesis (MLP) that restored blinking in patients with severe paralytic ptosis.[5, 17-
19] The force to lift the lid was produced by a static Neodymium magnet embedded in a glasses frame 
and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with Tegaderm IV 
securement film (Fig 1).  The Tegaderm is FDA approved for extended wear on the skin and even as an eye 
covering.  It generated a strong bond, keeping the magnetic array affixed to the eye lid skin for a mean of 
6 ± 4 days with good patient reported comfort when used for 2 hours per day during rehabilitation 
therapies. 
Translational Promise – This proposed research to further improve the approach and confirm 
safety, feasibility, and relative efficacy for chronic management of ptosis is needed prior to 
commercialization.  The aims of the proposed study target the clinical population of the PI who specializes 
in low vision rehabilitation with subspecialty in neurological visual impairments.  This is a large and 
underserved patient population which includes many individuals with recent neurological pathology, 
many of whom are residing in inpatient rehabilitation facilities (IRF). IRFs provide 24 hour medical 
supervision and rehabilitation therapies to patients who are medically stable and are able to participate 
in a minimum of 3 hours/day of therapy. There are 1,165 IRFs in the U.S.[20]  with an average length of 
stay of 16 days.[21] If we conservatively estimate an average of 50 beds per 1,165 IRFs revolving every 16 
days there should be approximately 1.2 million admissions and discharges per year in IRFs nationwide. Of 
that population, ~32% are recovering from stroke and 6% from traumatic brain injury.[21] Prevalence of 
CN III palsy in stroke populations has been reported at 2.5%,[22] and 4.4% in TBI (internal data).  
Therefore, the estimated national target population for temporary management of severe ptosis in IRFs 
alone is 12,000 patients annually.  In our IRF, internal review found a rate of 24 cases of severe ptosis in 
2015-2016.  No one stands to directly and immediately benefit more from this technology than patients 
with severe bilateral ptosis.  While this is presumed to be a rare situation we have encountered 8 such 
patients in the past 2 years without any active recruiting effort.  We have also encountered multiple 
patients with severe unilateral ptosis obscuring the vision in their better eye for whom surgery was 
contraindicated.  There is no available option for these patients other than taping the lids open or the 
ptosis crutch with the aforementioned problems with these approaches.     

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
5 
 
Scientific Premise:  In summary, the premise for the proposed work is that ptosis is a major 
public health concern which to this point has received less attention than it’s lagophthalmos counterpart 
despite the fact that it causes similar discomfort and disability (but without the extreme consequence of 
exposure and scarring).  Better non-surgical options are needed.  Weaknesses in prior work in the field 
concerning magnetic correction included use of ferrite magnets, inadequate adhesion methods for 
external placement, moving too soon to surgical implantation, and lack of evidence from randomized 
controlled trials to guide clinical approaches.  We will fill a significant gap in the field in terms of non-
surgical correction while not excluding use of data and methodology to advance success with surgical 
implantation.   In the first part of this study the magnetic levator prosthesis (MLP) was improved by 
development and testing of a novel adjustable force system and in the second part of the study the MLP 
will be compared to another non-surgical treatment for blepharoptosis, the Kinesio Tape frontalis sling 
(KTFS) 
 
 
2.3 
Potential Risks and Benefits  
 
2.3.1 Known Potential Risks  
Risks related to use of the MLP: 
Risk 1:  Dryness or soreness in the eye or on the lid skin from prolonged use of the MLP has been reported 
in a prior study of the MLP (Singh et. al 2016).  In that study (n = 6), “total usage time was 32 weeks, 3 
weeks, 1 week, 8 weeks, 2 weeks, and 2 weeks, in each patient respectively.  The average wear time of the 
device was 5 (±2) hrs/d. Patients 1,2,4,5-6 continued to use the device at the end of the study period while 
P3 recovered negating further need.  There were no adverse events (as predefined). Mild (2/10) skin 
irritation and worsening in superficial inferior corneal staining (from 0 to 2) occurred in P1’s first week 
after 8 hrs/d of wear.  Reducing wear time to 4 hrs/d and starting artificial tears every 4 hrs reversed SPK 
& prevented further complications.”    
Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary 
outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118. 
There have not been any cases of irreversible damage to the ocular surface occurring during use of the 
MLP and this would be extremely unlikely because the MLP is easily disengaged by removing the glasses 
and the lid magnet is easily removed with nylon tweezers.  We include the remote possibility of 
irreversible effects of extended exposure in the consent materials, which is meant to refer to any 
permanent ocular surface manifestation that may result from exposure ranging from minor dry sensation 
to scarring of the cornea.   
 
Risk 2, reduced blink reflex:  If the fitting of the MLP is not ideal, it is possible that participants (children 
and adults) would experience slowed or incomplete blink reflex.  There is the potential that this could 
cause reversible ocular surface drying and discomfort.  Participants, parents, and involved caregivers will 
be given specific instruction on how identify problems and when to remove the MLP.  To summarize, they 
will be instructed to ask themselves at regular intervals “what is my level of comfort on a scale of 1-10” 
and if it is lower than 5 to remove the MLP and contact the study staff to schedule a visit to investigate.   
It is also possible that a reduced blink reflex could elevate the risk of foreign body in the case of projectiles.  
All participants will be fitted with safety grade or polycarbonate lenses, in their prescription (or non-
prescription plano if they require none).  Participants will be instructed to wear additional protective 
eyewear and to avoid places like machine shops where there could be metal shavings.  The lid magnets 
are not strong enough to propel a magnetic/metal object towards the eye and the magnets should actually 
reduce the risk for metallic foreign body projectile entering the eye by redirecting it towards the spectacle 
magnet; however, there is risk that metal shavings could accumulate around the magnets if the device is 

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
6 
 
used in a situation such as a workshop where shavings are present.  While these would not be projected 
into the eye, minor injury may result if the shavings get around the eye and then are rubbed into or 
sprinkle into the eye(s).  Standard safety goggles will fit over the spectacles and participants will be 
informed that they should be worn as they normally would.   
 
Risks related to KTFS taping: 
Kinesio Tape is FDA registered with an indication for extended use on the skin.  Clinically it is most often 
used on the upper extremities to support sore or injured muscles.  It is also often used on the face for 
facial palsy [7], and sometimes on the eye lids for blepharoptosis.  It is easily removed without any special 
tools or procedures.  Similar to the MLP, there is the possibility that participants might experience ocular 
surface drying and discomfort. There is also a possibility of skin irritation from the tape. Participants, 
parents, and involved caregivers will be given specific instruction on how to identify problems and when 
to remove the tape.   
 
2.3.2 Known Potential Benefits  
Possible treatment for restoration of eyelid motility in subjects who wear the device comfortably. 
  
3 
OBJECTIVES AND PURPOSE 
To provide a higher level of evidence for the MLP as an emerging treatment, and to 
determine barriers to displacing current non-surgical and temporary approaches. 
To improve the magnetic levator prosthesis (MLP) by development and testing of a novel adjustable force 
system. If endpoints are met and the device is determined to be feasible the study will continue to a 
randomized clinical trial comparing the MLP against the predicate treatment of taping the lids. 
 
4 
STUDY DESIGN AND ENDPOINTS 
 
4.1 
Description of the Study Design 
The study is a double-blind, randomized crossover clinical trial comparing two non-surgical treatments, 
the MLP and KTFS, for blepharoptosis. After the end of the crossover, there will be an optional extended 
wear period in which participants may be invited to continue using the preferred device for up to another 
six months, if clinically appropriate. 
4.2.1 Primary Endpoints 
A difference between MLP and KTFS of at least 1mm in the change in interpalpebral fissure during 
opening and spontaneous blinking.  
 
5 
STUDY RECRUITMENT, ENROLLMENT AND WITHDRAWAL 
 
Patient Gateway for recruitment will be utilized. 
 
5.1 
Participant Inclusion Criteria: 
1. 
Presence of Blepharoptosis for at least one eye which occludes the visual axis in the resting state (no 
frontalis drive),  
2. 
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.  

Clinical Trial to improve the magnetic levator prosthesis (MLP) including the development and testing of a novel adjustable 
force system and comparison to the Kinesio Tape frontalis sling (KTFS)  Version 1 
 
 
 
 
7 
 
3. 
Age 5 or older.   (Children need to be included because they represent an important target 
population (pediatric neuro-muscular conditions), and because facial structure and skin 
characteristics may result in a different response than adults) 
 
5.2 
Participant Exclusion Criteria: 
1. 
Absence of ptosis which occludes the visual axis  
2. 
Presence of a corneal ulcer of any size, unless managed with a protective contact lens or other 
method and permission is granted from the candidate’s managing eye doctor.   
3. 
Age less than 5,  
4. 
Severe Cognitive impairment defined as MMSE score <18, behaviors consistent with delirium 
(combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy.  
5. 
Presence of corneal hypoaesthesia unless cleared for enrollment by a cornea or contact lens 
specialist; 
6. 
Orbicularis weakness on the side of the ptosis.  
7. 
Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the 
movements of the upper lid, and enophthalmos. 
8. 
Previous ptosis surgery less than 3 months prior to Visit 1. 
9. 
Lid position affected by lid or conjunctival scarring. 
10. History of herpes keratitis. 
11. 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. 
12. 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.  
 
Hypoaesthesia and chronic corneal ulcers may be treated successfully, usually with artificial tears and/or 
a protective contact lens.  Therefore, when there is hypoaesthesia or chronic epithelial defect the PI will 
contact the candidate’s cornea or contact lens specialist (e.g. via email or EMR message (EPIC)), and 
request permission to enroll the candidate.  If they do not have a cornea or contact lens specialist, a 
consult with one at MEE who is not affiliated with the study will be requested prior to enrollment.         
 
5.3 
Strategies for Recruitment and Retention 
Subjects will be recruited from two main sources: 
 
1. 
Subjects will be recruited from the PI’s clinical practice, which specializes in patients with 
low vision related to neurological conditions.  Several ophthalmologists, neurologists, and 
physiatrists in the MGB system are aware of the PI’s expertise in severe neuro and 
myogenic ptosis and associated strabismus, and routinely refer their patients to the PI’s 
clinic where they will be offered participation if appropriate. Subjects recruited from the 
PI’s clinic will be contacted by telephone, email or letter with brief details about the study 
(see attached telephone script and email/letter script). For participants who are among 
the investigator’s own patients, the risks of coercion or undue influence will be minimized 
by having a study team member other than the PI contact the patient about the study. 
 
2. 
Subjects will be recruited from other relevant clinics within the MGB network (e.g., the 
MGH neuromuscular clinic). Non-study staff physicians at MEEI and other local Boston 

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area practices within the MGB network will be sent a letter (see uploaded practitioner’s 
letter) asking them to provide approved study recruitment flyer (see uploaded flyer) to 
potential participants.  The flyer includes contact information so the participant can 
directly contact a member of the study team.  In addition, flyers may also be posted in 
public areas in clinics, when permitted.           
 
We do not anticipate any problems with subject retention. Typically patients are eager to participate 
because we are providing treatments that may improve eye opening. Subjects will receive regular 
follow ups which will help facilitate retention.  Participants will receive remuneration for 
participating in this research study. They will receive $60 at the end of the second period of 
the crossover (typically visit 6).  This will be done using a CliniCard.   
 
5.4 
Participant Withdrawal or termination 
 
5.4.1 Reasons for Withdrawal or Termination 
Subjects have a right to withdraw from the study at any time. Additionally, the subject may be withdrawn 
from the study for any reasons: if it is in the best interest of the subject, intercurrent illness, adverse 
events, or worsening condition.  The site investigators may request the withdrawal of a subject because 
of protocol violations, administrative reasons, or any other valid and ethical reasons.   
Reasons for subject discontinuation may include, but are not limited to, the following: 
1. 
Investigator determination that it is not in the best interest of the subject to continue 
participation 
2. 
Serious adverse events 
3. 
Any other safety concerns 
 
5.4.2 Handling of Participant Withdrawals or termination 
If a participant needs to withdraw early, they will be asked to accept a final telephone call at the end of 
the study to confirm vital status.  Participants who are withdrawn due to an adverse event, serious or not, 
will be followed until the resolution of the event.   
 
5.5 
Premature Termination or Suspension of Study 
If the study is terminated or suspended prematurely, all enrolled participants will be notified and asked 
to attend a final safety visit.  If there are participants with ongoing adverse events at the time of premature 
termination those participants will be followed until resolution of the event.   
 
6 
STUDY Device 
 
6.1 
Study Device Description 
 
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).  It generates a strong bond, in a prior study keeping the magnetic array 
affixed to the eye lid skin for a mean of 6 ± 4 days with good participant reported comfort when used for 

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2 hours per day during rehabilitation therapies.  In order to allow doctors and patients to easily adjust the 
force of the MLP in the interest of maximizing their comfort and blink quality while accommodating 
variability in ptosis or lid magnet positioning, we propose to further develop and test a novel approach 
where the force is adjusted by manually rotating the spectacle magnet with a small dial on the side of the 
spectacle frame.  The MLP is FDA exempt as a Class 1 Device.  An Investigational Device Exemption (IDE) 
application was not required in prior studies approved by the MEEI IRB HSC and should not be required in 
order to carry out this study.  MLP status as a device was reviewed extensively by Leila Foster and her 
team as well as by legal (Maureen Kelley), last reviewed in fall 2017.    
 
Kinesio Tape Frontalis Sling (KTFS): 
Kinesio Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational 
therapists 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. 
 
 
6.1.1 Acquisition 
Magnets will be acquired from SM Magnetics, Pelham AL or similar supplier.  PDMS supplies will be 
acquired from Fisher Scientific.  Frame supplies will be acquired from Designs For Vision Rokokam, NY , 
Michelle Moretti Eyeware and Skelmet, Boston MA.  Kinesiotape will be acquired from  Kinesio Holding 
Corporation, Albuquerque, NM. 
 
6.1.2 Formulation, Appearance, Packaging, and Labeling 
Arrays will be labeled with lot and batch numbers.   
 
6.1.3 Product Storage and Stability 
Only the arrays have an expiration date.  Neodymium magnets are highly stable and resistant to 
demagnetization.  The spectacle magnets will have an expiration of 5 years.  The PDMS arrays will have 
an expiration of 1 year.  They are stored at room temperature.   
 
6.1.4 Preparation 
Magnets are prepared by the manufacturer and coated in nickel.  They will be embedded in PDMS at 
Schepens Eye Research Institute using a mold produced onsite with a 3-D printer.   
 
6.1.9 Duration of Therapy 
see other sections 
 
6.1.10 Device Specific Considerations 
The MLP is FDA exempt as a Class 1 Device and therefore an Investigational Device Exemption 
(IDE) application was not required in prior studies approved by the MEEI IRB HSC and should not be 
required in order to carry out this study.  MLP status as a device was reviewed extensively in the fall of 
2017 by Leila Foster and her team as well as by legal (Maureen Kelley).  Mass Eye and Ear has submitted 
a patent application for the technology, and so status was also reviewed by Ojas Mehta and his team in 
the Intellectual Property department.        

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Kinesio Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and 
occupational therapists to support muscular healing and movement. It is currently used as a treatment to 
support the lid in cases of severe blepharoptosis. As such an IDE should not be required. 
 
6.2 
Study agent Accountability Procedures 
The devices will be stored in the lab offices at Schepens Eye Institute and dispensed at Massachusetts 
Eye and Ear in the vision rehabilitation service clinical research lab (8th floor, 243 Charles St).  Logs will 
be kept by the Research Assistant and Engineering Research Fellow to keep account of which devices 
were used for the specific subjects.  If devices are returned that will also be noted on the device logs. 
 
7 
STUDY PROCEDURES AND SCHEDULE 
  
7.1 
Study Procedures/Evaluations 
 
7.1.1 Study specific procedures  
The following procedures will be performed as part of the study (see schedule of events table in section 
7.3.7.) 
1. 
Refraction (if needed) 
2. 
Visual acuity  
3. 
Slit lamp examination of external eye, lid and cornea with Nafl & NEI scale 
4. 
Comfort rating 
5. 
Video recording of eye blinks  
6. 
Rating of skin integrity 
7. 
EQ-5D-5L questionnaire 
8. 
GBI questionnaire 
9. 
aQoL questionnaire 
 
Based on experience, we anticipate that the first study visit will typically last about 120 minutes and 
subsequent visits about 60 minutes.  
Some of the visits will be conducted virtually (as detailed in subsequent sections). To facilitate virtual 
visits, a visual acuity chart will be given to the subject to allow this safety outcome monitoring remotely 
and other safety outcomes will be conducted during the call (comfort scale, inspection of the external 
eye and lid skin).   
 
Detailed plan for REDCap text message and email communication: 
A short three-question survey will be used to document whether subjects are wearing a device 
during the periods of home use. Consent to receive a survey link by text message or email will be 
documented in the consent form along with the preferred contact method (text, email, or both). For 
subjects that consent to receive the survey links, their preferred phone number and/or email address will 
be recorded on a sheet separate from the consent form, which will be kept in a locked cabinet in a locked 
office. As soon as the phone number and/or email address have been input into REDCap, the original will 
be shredded.  
Subjects who consent to receive the survey links will receive a text message or email (based on 
their communication preference) with a link to a REDCap survey twice daily when using one of the devices 
at home during the trial week. Please see uploaded document for details of the survey language and 
questions. Subjects will be able to decline receiving the survey links at any time.  

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Text message plan: Text messages will be sent to subjects using the Twilio platform. The “Survey 
as webpage” option will be selected so that subjects can access the REDCap survey URL directly from the 
text. Subjects’ phone numbers will only be entered if they consented to receiving messages in this way. A 
sentence in the text message will notify the subject that they can opt out of receiving these texts by 
replying “Stop”. 
Email plan: In the event that subjects prefer to be contacted by email, they will receive the link 
to survey sent to their email through the REDCap platform. The “automated invitations” option will be 
used to send out emails at certain times of day to the subjects. Subjects’ emails will only be entered if 
they consented to receiving messages in this way. A sentence in the email message will notify the subject 
that they can opt out of receiving these emails by replying “Stop”. 
 
7.3 
Study Schedule 
 
The study schedule is summarized below (section 7.3.7).  
 
7.3.1 Screening 
Pre-Screening:  In order to guide the consent/assent process, the approved study staff will 
administer a pre-consent cognitive screening using the Mini-Mental State Exam (MMSE).  If score 
is 18-23 (maximum of 30) representing mild cognitive impairment (Tomburgh et al 1992), 
candidates will be asked to return with a caregiver (if one is not present).  If score is <18, they 
will not be eligible.  
 
Screening: Subjects with MMSE scores of at least 18 will undergo consent procedures at the start 
of the first visit. After consent, the eligibility check list (uploaded) will be used to determine 
eligibility. Only eligible subjects will be enrolled in the clinical trial.   
 
7.3.2 CROSSOVER 
After consent and enrollment, subjects will be randomly assigned to one of the two 
arms for the crossover period. In one arm subjects will receive the MLP first and the KTFS 
second. In the other arm, subjects will receive the KTFS first and the MLP second.  
Each period of the crossover will last for about three weeks, including about two weeks 
of training in how to apply and remove the device followed by about one week of using the device 
at home. Training will be conducted at study visits at Mass Eye and Ear. Typically there will be 
two training visits. Baseline measures of eye lid blinking without and with the device will be taken 
during training. For the MLP, two baseline measures of eye lid blinking will be recorded one with 
the real MLP device and one with a sham MLP device to determine how much improvement 
might occur simply through a placebo effect. However, for the KTFS it will not be possible to take 
a baseline measure with a sham KTFS. Only subjects and caregivers who demonstrate sufficient 
ability to apply and remove the device will be permitted to take it home. During the period of 
home wear, there will be a video call every other day to monitor the subject’s use of the device 
and safety.  During the kfts arm, an occupational or physical therapist consulting with the 
Massachusetts eye and ear study team may talk with the subject during the video conference call 
to ensure that the kinesio tape is in the correct position.  Mass General Brigham approved 
software will be used for video calls. During the trial week of home use of devices, subjects will 

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also receive REDCap survey link notifications each day to complete a brief survey to log if they 
are wearing the device (see the detailed plan above, and see attached document for survey 
language and questions).  
To ensure no carry-over effects, there will be a washout of about 2 weeks duration 
between the first and second period of the crossover during which subjects will not be 
permitted to use any device for their blepharoptosis. (This will be similar to their habitual state 
before enrollment since none of the participants would have been using any device for their 
blepharoptosis about two weeks before enrollment).  
At the end of the second period of the crossover, subjects will receive a phone call at 
which the comparison questionnaire (comparing the two devices) and the debriefing 
questionnaire will be administered. Subjects who express a preference for one of the devices and 
are interested in continuing to use the preferred device will be asked to attend Mass Eye and Ear 
for a study visit with Dr. Merabet determine whether it is clinically appropriate for them to 
continue with the preferred device. Subjects who do not wish to continue with either of the 
devices will have no further in-person study visits after this point (but will be asked to complete 
the 6 and 12 month telephone follow ups), and they will be asked to return the study device 
unless they get special approval from the clinic to keep it as part of their continued treatment.  
 
 
7.3.3  EXTENDED WEAR Follow-up 
Only subjects for whom the study doctor determined it was clinically appropriate to continue 
with the preferred device (either MLP or KTFS) will be invited to participate in the extended wear part of 
the clinical trial.  The extended wear will involve about six months of home-use of the preferred device 
with a study visit at every one month period. More frequent monitoring visits may be requested by the 
study doctor based on clinical judgment.  During the extended wear period, subjects may also receive 
REDCap survey link notifications each day to complete a brief survey to log if they are wearing the device. 
Please see section 7.3.7 for procedures that will be conducted at follow up visits. 
 
7.3.4 Final Study Visit 
At the final study visit (at the end of the extended wear) a clinical decision will be made as to whether or 
not the MLP or KTFS is recommended for continued use. Participants will be allowed to take the preferred 
device (MLP or KTFS) and continue wearing it, if considered clinically appropriate, and transferred to the 
clinical practice of the PI.   
 
7.3.5 Long-term follow up: 6 and 12-month telephone follow ups 
 All subjects will be called at 6 & 12 months after the final study visit to complete some of the same 
questionnaires from earlier in the study (regardless of participation in extended trial). If subjects had 
continued using the device after the final study visit, the study staff will also ask them about device use & 
abandonment.   
 
7.3.6 Early Termination Visit 
 In the event a participant is terminated from the study due to an Adverse Event, the study PI will follow 
the participant for at least 30 days after termination to confirm the event has resolved or the patient is 
receiving appropriate treatment.  
 
7.3.7 Schedule of Events Table 

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*Visits 8-10 are in office, approximately every second week. There will be video 
call follow ups on weeks without an in-office visit  
 
 
7.5 
Concomitant Medications, Treatments, and Procedures  
 
Oral and ophthalmic concomitant medications will be reviewed and recorded to confirm the patient 
does not have any systemic disease that would interfere with the study assessments and or data. 
 
 
Consent 
EQ-5D-5L Questionnaire 
aQoL Questionnaire 
GBI Questionnaire 
Visual Acuity 
SlitLamp, skin rating, & NEI 
grading 
Video Recordings & 
Comfort ratings 
Application & Removal 
training 
Debrief and device 
comparison questionnaire 
Clinical decision 
 
 
Device 1 
Visit 1 
x 
x 
x 
x 
x 
x 
x 
 
 
Visit 2 
 
 
 
x 
x 
x 
x 
 
 
 
About 1 week wearing at home with video calls for safety monitoring and 
daily survey about wear time 
Visit 3 
 
x 
x 
x 
x 
x 
x 
 
 
 
 
Washout (about 2 weeks) 
 
 
Device 2 
Visit 4 
 
x 
x 
 
x 
x 
x 
x 
 
 
Visit 5 
 
 
x 
x 
x 
x 
 
 
 
About 1 week wearing at home with video calls for safety monitoring  and 
daily survey about wear time 
Visit 6 
x 
x 
x 
x 
x 
x 
 
 
 
 
End of crossover period 
 
Phone call 
 
 
 
 
 
 
 
 
x 
 
 
Visit 7 
 
 
 
 
x 
x 
x 
 
 
x 
 
Start of extended wear trial (about 6 months) 
Chosen 
device 
Visit 8 
 
x 
x 
x 
x 
x 
x 
 
 
 
Long term follow up 
 
6 month 
phonecall 
 
x 
x 
x 
 
 
 
 
 
 
 
12 month 
phonecall 
 
x 
x 
x 
 
 
 
 
 
 

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7.5.1 Precautionary Medications, Treatments, and Procedures 
None. 
 
7.6 
Prohibited Medications, Treatments, and Procedures  
Ophthalmic ointment or skin ointment applied near the eyes interferes with adhesion of the lid magnet 
and will need to be discontinued at least 1 day prior to the study.  Patients may continue with artificial 
tears.     
 
7.9 
Participant Access to Study Agent At Study Closure  
 
If considered clinically appropriate, participants will be allowed to take the MLP and continue wearing it 
after completion of the study, or to continue with the KTFS after completion of the study.  MEEI has 
already approved provision of the MLP to non-research subject patients under the Humanitarian Devices 
rules, and Kinesio Tape is commonly used as a treatment for ptosis.    
 
7.10  
Virtual Visits 
 
REDCap consent module will be used to obtain econsent. 
 
In 2022, the NIH provided a supplement to allow virtual enrollment of up to 10 
participants to help meet enrollment goals while promoting greater diversity of the study sample.  
Study procedures will be identical to those described in section 7.3, but will be conducted 
virtually via video visit.  Methods for virtual monitoring of active participants during the pandemic 
related shutdown were developed and successfully implemented during the in 2020, as described 
in prior sections.  The key differences and logistical solutions needed for entirely remote 
participation are summarized here:  
Prior to consideration for enrollment, candidates will be required to provide a copy of a 
complete eye exam by any licensed provider conducted within the 3 months prior to the pre-
screening consent video visit.  The first video visit will be for the pre-screening MMSE. A visual 
acuity paper chart, and supplies for corneal sensitivity testing will be mailed to candidates ahead 
of this first visit. Study activities will not begin until the second video visit, to allow time for 
participants to receive a study equipment package in the mail from us.  The package will include 
device supplies, device application instructions, Burton lamp artificial tears and NaFl strips (for 
remote cornea exam), paper questionnaires, and instructions for downloading a visual acuity and 
external eye photography app.  Everything described in section 7.3 will be done on the video visit 
platform including but not limited to training to self-apply the lid devices and video recording of 
blinking.   
 
 
 
8 
ASSESSMENT OF SAFETY 
 
8.1 
Specification of Safety Parameters 
The safety of the study devices will be evaluated at every visit following the enrollment visit and will be 
defined by the incidence of related adverse events. Specifically, we will evaluate:  

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10. 
Systemic safety: Incidence and severity of systemic adverse events during the study (adverse 
events spontaneously reported or observed by the Research Assistant).  
11. 
Ocular safety: Incidence and severity of ocular adverse events during the study (ophthalmic 
examination, adverse events spontaneously reported).  
SAFETY CUTOFFS:  Serious adverse events which would result in study suspension:  Should visual 
acuity decrease more than 2 lines, worsening of corneal rating of more than 1.5 points or other 
ocular surface ratings more than 2 points, and comfort rating lower than 5/10; study activities 
will cease for at least 1 week and an adverse event report will be sent to the IRB.  Corneal rating 
changes >1.5 points will be reviewed by the independent safety monitor at the Eye and Ear to 
determine if criteria for study suspension or dismissal are met, and when it may be possible to 
continue.   Serious adverse events which will result in immediate dismissal from the study (and 
treatment) include: 1) development of a related corneal ulcer (as judged clinically by the 
independent safety monitor) with or without infiltrate or 2) broken skin on the eyelid (skin 
decompensation).  
 
 
8.1.1 Definition of Adverse Events (AE) 
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human subject, including any 
abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, 
temporally associated with the subject’s participation in the research, whether or not considered 
related to the subject’s participation in the research.  
 
8.1.2 Definition of Serious Adverse Events (SAE) 
Serious Adverse Event (SAE): Any event temporally associated with the subject’s participation in 
research that meets any of the following criteria:  
1. 
Results in death  
2. 
Is life threatening  
3. 
Requires hospitalization/prolongation of hospitalization  
4. 
Results in congenital anomaly  
5. 
Results in persistent or significant disability/incapacity  
6. 
Required intervention to prevent permanent impairment/damage  
 
8.1.3 Definition of Unanticipated Problems (UP) 
Any incident, experience, or outcome (including data loss) that is unexpected (in terms of nature, 
severity, or frequency) given (a) the research procedures described in the protocol and the 
characteristics of the subject population being studied. Unanticipated problems may include protocol 
deviations that are not adverse events 
 
8.2 
Classification of an Adverse Event 
The Investigator will promptly review documented adverse events and abnormal findings to determine 
1) if the abnormal finding should be classified as an adverse event: 2) if there is a reasonable possibility 
that the adverse event was caused by the study device(s); and 3) if the adverse event meets the criteria 
for a serious adverse event. 
 
8.2.2 Relationship to Study device 

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If an adverse event or serious adverse event is recorded the study PI will determine the relationship to 
the study device.   
 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up 
Adverse events or abnormal findings thought to be associated with the study device will be followed 
until the event (or its sequel) or the abnormal finding resolves or stabilizes at a level acceptable to the 
Investigator.  Events that have not resolved or stabilized will be followed for 30 days post study 
completion. Subjects will be encouraged to follow up with their physician for the treatment of any 
events beyond 30 days post study completion. 
 
8.4 
Reporting Procedures 
 
8.4.1 Adverse Event Reporting  
All adverse events will be reviewed by the principal investigator within 24 hours of notification and 
reported to the Mass Eye and Ear IRB on the following schedule: 
7. 
Possibly, Probably, or Definitely Related Expected AE – Report to IRB on annual basis 
8. 
Possibly, Probably, or Definitely Related Expected Serious AE – Report to IRB within 7 days 
9. 
Possibly, Probably, or Definitely Related Unexpected AE – Report to IRB within 30 days of event 
10. 
Possibly, Probably, or Definitely Related Unanticipated Problem – Report to IRB within 7 days of 
event (24 hours for death or data loss) 
11. 
Possibly, Probably, or Definitely Related Unexpected Serious AE – Report to IRB within 7 days of 
event (24 hours for death) 
 
8.4.2 Serious Adverse Event Reporting  
Any adverse events that are serious, unexpected and related or possibly related to the study will be 
reported to the Mass Eye and Ear IRB within 7 calendar days from the time the PI becomes aware of the 
event. Any unexpected and study-related death will be reported to the Mass Eye and Ear IRB within 24 
hours of the PI’s knowledge of the event by e-mail or telephone.  
 
8.4.3 Unanticipated Problem Reporting  
All UAPs involving risks to subjects or others will be reported in writing to the Mass Eye and Ear IRB within 
7 calendar days from the time the PI becomes aware of the event. If a UAP or an unexpected SAE results 
in a subject’s death or was potentially life-threatening, the PI will notify the Mass Eye and Ear IRB through 
e-mail or phone within 24 hours from the time the event is identified. A follow-up report will be submitted 
if applicable, at a later date when more information is available.  For UAPs that result in data loss the PI 
will notify the Mass Eye and Ear IRB through e-mail or phone within 24 hours from the time the UAP is 
identified.   
 
10 
STATISTICAL CONSIDERATIONS  
 
10.1 
Statistical and Analytical Plans 
Statistical analysis plans are summarized in the subsequent sections.  
 
10.2 
Statistical Hypotheses 
Primary outcome measure: 
 

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Statistics for the participant characteristics will be presented in terms of mean ± standard deviation or 
median ± interquartile range (25th to 75th). Within subjects repeated measurements, linear mixed effects 
regression will be used to determine the effect of treatment condition on the IPF values (spontaneous 
and resting state open), with a random intercept for the subject factor. Subject age, gender, blink 
sequence (the order of the blink recorded in the video), and the order of interventions (whether 
evaluated in the first or the second arm of the crossover) will be covariates of interest. Effect of each 
covariate will be investigated alone, and only statistically significant (P<.05) covariates will be included in 
the final regression model, from which, the estimated marginal means and their 95% confidence interval 
(CIs) will be reported for each of the outcomes. Missing values at the T2 time point will be imputed from 
another time point within the same subject (T1 by default or T0 if both T1 and T2 were not available). 
For volitional blinks, a test of proportionality will be performed to determine the effect of the 3 
treatments on the probability of eye not fully closing.  
 
10.3 
Analysis Datasets 
 
The dataset for the analysis of the primary outcome measure will be an intention-to-treat 
dataset.   
 
10.4 
Description of Statistical Methods 
 
10.4.1 General Approach 
This clinical trial uses a prospective, double-masked, within-subjects crossover design.  Descriptive 
statistics for continuous data for each of the primary and secondary endpoints will be presented as means 
with standard deviations or medians and ranges, as appropriate. The normality of the data will be 
examined and appropriate statistics and descriptives used based on the results.  
Measurements of Eye Lid Kinematics: 
Our main measures of device efficacy involves the measurement of eyelid kinematics from video 
recordings made at various timepoints throughout the clinical trial. Measurements may be made 
manually within NIH’s image J software, automatically using a software we create (in Python or similar 
platform), or using crowdsourcing with Amazon Mechanical Turk. 
 
 
10.4.2 Analysis of the Primary Efficacy Endpoint(s) 
 
We will use a repeated measures mixed effects model for analysis of the primary outcome measure 
(change in interpalpebral fissure during opening and spontaneous blinking). The model will include a 
random subject-level intercept and a fixed treatment effect (MLP or KTFS). A repeated measures model 
will be used with primary timepoint for analysis being after 1 week of use.  . The model will also include 
fixed effects of treatment order (i.e., MLP: KTFS vs KTFS:MLP), and crossover period (period 1 or 2), and 
will control for age and sham opening interpalpebral fissure.   
   
10.4.3 Analysis of the Secondary Endpoint(s) 
The change in interpalpebral fissure during volitional blinking will be analyzed using the same approach 
as for the primary outcome measure.Questionnaire responses will be summarized using descriptive 
statistics and analyzed using non-parametric tests. 
 
10.4.4 Safety Analyses 

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Clinical study staff will acquire high resolution magnified images of the ocular surface and eyelid 
skin which will be reviewed by the PI and at least 1 other study team member with clinical 
training will produce quarterly reports to be reviewed by the independent safety monitor.  On-
site monitoring of participant safety will be utilized by the PI or other study personnel.  This is 
appropriate since problems can be immediately detected and addressed by research staff 
experienced in examination of the eye.  A monitoring log of expected and unexpected events 
will be kept.  Events will be documented on paper and sent to the PI (if he is not the one 
examining the participant) who will place a follow-up call to the participant that day and the 
next day as needed.  Paper documentation will be kept in the study binder and then transferred 
to a worksheet in the study master spreadsheet.  Non-compliance with protocol (e.g. failure to 
use the study checklist or properly document or report in a timely manner adverse events) will 
be documented.  Once identified, minor issues will be addressed by the PI by special meeting or 
at weekly study meetings.  Special meetings will be called depending on the seriousness of the 
issue.  Repeated offenses will result in removal of that study staff from the protocol. Adverse 
events will be documented and reported to the IRB and NEI per protocol.   
 
10.4.5 Adherence and Retention Analyses 
Data summaries will be produced (including data on subject enrollment, withdrawals, primary 
outcome measures, and any safety issues) on a periodic basis and reviewed by the PI, other 
study personnel and the independent safety monitor.  
 
 
10.4.6  Baseline Descriptive Statistics 
Baseline data will be summarized using descriptive statistics, as appropriate.  
 
10.4.7 Planned Interim Analyses  
 
10.4.7.1Safety Review 
The data summaries will be reviewed by an internal committee comprising the PI and members 
of the research team to monitor data quality, study progress and determine whether the study should 
change in any way or be stopped. Data summaries will be sent to the independent safety monitor on a 
quarterly basis for a safety review (at the monitor’s discretion) and to determine whether the study should 
change in any way or be stopped. Serious (expected or unexpected) adverse events will be reported 
immediately to the PI (by a subject or member of the research team).  
Minor adverse events (e.g. mild discomfort of the lids) will be recorded on a subject’s data sheet 
at the time of occurrence; they will subsequently be reported  internally for that study.  Minor adverse 
events will also be reported on an annual basis to the relevant IRB committees, as part of the annual IRB 
review of each approved study. 
 
10.4.7.2 
Efficacy Review 
Preliminary data analyses will occur periodically.   
 
10.4.8 Additional Sub-Group Analyses 
Subgroup analysis is not part of the analysis plan 
 

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10.4.9 Multiple Comparison/Multiplicity 
P-values used to indicate significance will be corrected where appropriate.  There is no plan for multiple 
comparisons.   
 
10.4.10 
Tabulation of Individual Response Data 
Individual response data will be recorded on data sheets and input into Excel spreadsheets. 
 
10.4.11 
Exploratory Analyses 
 No exploratory analyses are planned. 
 
10.5 
Sample Size 
Sample size was estimated based on available preliminary data at the time of study planning, estimating 
40 would need to complete the crossover with an estimated attrition of 10 giving a total of 50 planned 
for enrollment.  However, this was able to be greatly reduced given the size of the effects measured in 
the interim analyses conducted after 8 participants had completed the crossover.  The final sample size 
required to measure the primary outcome with power of 0.80 and type II error of alpha 0.05 was 16.   
10.6 
Measures to Minimize Bias 
 
10.6.1 Masking AND RANDOMIZATION Procedures 
Masking: 
Subjects will be masked as to which of the two devices is the new treatment. They will simply be told that 
they are evaluating two non-surgical treatments for blepharoptosis. A debriefing questionnaire will be 
administered after the second period of the crossover to determine whether subjects guessed that the 
MLP was the new treatment and the KTFS was the comparison treatment. 
Data assessors (e.g. Turkers) for the primary outcome will be masked since they will not be familiar with 
the study or the 2 treatments. They will review videos of blink dynamics which have been cropped to show 
only the eye region so the subject cannot be identified (see Measurements of Eye Lid Kinematics in section 
10.4.1).   
The person conducting statistical analyses of the primary outcome will be masked. 
It is not possible to mask the study team member who will fit and provide training for the MLP device, 
since the fitting requires specialist expertise. That study team member will avoid telling subjects that the 
MLP is the new treatment. Furthermore the quantification and analysis of the primary outcome will be 
conducted by masked data assessors. 
A person external to the study team will fit and provide training for the KTFS. Again, it will not be possible 
to mask this person. However, this person is highly experienced in using Kinesio Tape, a proponent for its 
use for blepharoptosis, and has received training in fitting Kinesio Tape for ptosis. Again they will avoid 
telling subjects that the KTFS is the comparison treatment, and the quantification and analysis of the 
primary outcome will be conducted by masked data assessors. 
Recruitment for the clinical trial has been very successful so far. However the greater number of subjects 
than initially anticipated means that we have been running into problems when trying to schedule visits 
with the Physical Therapy Team Member (PT) for fitting of the kinesiotape frontalis sling (KTFS). The PT 
sometimes does not have sufficient room in her clinic schedule to accommodate a  taping visit per the 
schedule in the protocol. We’ve described a backup plan below to ensure that participants receive taping 
visits per the original protocol schedule even when the PT is not available.  Please note that the proposed 
plan requires that the PT will provide oversight of all taping visits by reviewing videos of the taping 
sessions. 

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As a backup plan in case scheduling constraints mean that it is not possible to schedule a taping visit with 
the PT: 
1. 
The PI will perform the tape placement. 
2. 
The PI or the research staff will be in attendance as the participants practice placing the tape. 
3. 
The entire process will be recorded and the video loaded onto a secure server or shared via 
Institutional DropBox 
4. 
The PT will be responsible for reviewing the videos within two days of placement, to ensure 
proper technique. 
 
  
Randomization 
Participants will be assigned to one of two possible treatment allocations: 1) MLP then KTFS or 2) KTFS 
then MLP. The allocation will be performed using software that implements the process of minimization. 
The first participant will be assigned randomly with each subsequent participant assigned in such a way 
as to approximately balance the number of participants who are 65 years of age and over and who have 
acute vs chronic ptosis. We propose to balance for these two factors because adults over the age of 65 
typically have thinner and looser eyelid skin, and participants with acute ptosis may recover while enrolled 
in the study, which may affect outcomes. Letter codes, randomly assigned to each of the treatment 
allocations by a researcher external to the study will be used by the software. The code breaker will be 
kept in a sealed envelope in a location known only to the external researcher. Data provided to the masked 
data assessors and the masked person conducting statistical analyses will use the letter codes to identify 
treatment allocation.  
 
10.6.3 Breaking the Study Blind/Participant Code 
The PI will determine if for safety reasons, the study staff needs to be unblinded on a subject by subject 
basis and/or during a specific study visit  
 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Data collection sheets will be completed for each subject enrolled into the clinical study.  Data Collection 
sheets will be study visit specific and the research technician (oversight by PI) will review and sign 
each subject visit for completeness and document any minor protocol deviations. Investigator’s 
signature or record locking serving as attestation of the responsibility for ensuring that all clinical data 
entered on the data collection sheets are complete, accurate and authentic.   
All computer generated data will be stored on internal MEEI servers located on encrypted, password 
protected MEEI computers. Only the PI and researchers specific to this study who have been granted 
access to the data by the PI will be able to view the data in the MEEI network protected folder. If data is 
sent out to be analyzed the data will be de-identified. The data will contain subject identification 
numbers, which are linked to identifiers on a separately secured spreadsheet. The data will be coded by 
assigning each participant a subject identification number and removing any identifiable information. 
The code will be secured by the PI and Study staff in the drive located on encrypted, password protected 
computers at Schepens. The code that links information that can identify the participant to the data 
collected for this research will be kept separate from their health information, which will be destroyed 
once this study is complete and the manuscript has been published. 
 
12 
QUALITY ASSURANCE AND QUALITY CONTROL 
The Principal Investigator will be responsible for quality assurance during this study.  The Principal 
Investigator will confirm that the study device is stored correctly.  The Principal Investigator will also 

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train study staff on the protocol procedures and will confirm staff can confidently complete the study 
related assessments.   
 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS  
 
13.1 
Ethical Standard  
All staff designated to work on this trial will have CITI certification for confirmation of GCP training and 
their CV’s, licenses and other forms of certifications related to conducting research will be kept with the 
study regulatory binder. 
 
13.2 
Institutional Review Board  
The IRB of record for this study will be the Mass General Brigham IRB.  The protocol will be approved 
prior to subject enrollment and will be reviewed yearly after initial approval.  Any adverse events or 
serious adverse events will be reported to the Mass General Brigham IRB office; however this is not 
expected to occur because this is a minimal risk protocol.     
 
13.3 
Informed Consent Process  
Subjects are required to sign an informed consent before participating in the study. The consent will be 
signed in front of a study team member (witness). The witness and investigator will sign and date the 
consent form. A note will be made on the study record that the informed consent was signed by the 
participant. The informed consent will follow the guidelines set by the Mass General Brigham IRB. A copy 
of the consent form will be given to the participant. A member of the study team will review the study 
procedures, visit schedule, risk and benefits, alternative treatments and rights to withdraw and ask 
questions with all potential subjects before signing the consent. Every participant has a right to withdraw 
at any time from the study without affecting their care or relationship with the treating physician and 
participating institution. The financial responsibilities of the participant will be discussed. All participants 
are required to sign a Health Insurance Portability and Accountability Act (HIPAA) form before 
participating (unless this is combined with the consent). A study member will explain and discuss with the 
participant their confidentiality rights as described in the HIPAA form. 
 
13.3.1 Consent/assent and Other Informational Documents Provided to Participants 
Consent and assent forms have been uploaded. 
 
13.3.2 Consent Procedures and Documentation 
Participants who are determined by their clinical specialist to have Blepharoptosis will receive a 
recruitment packet from the services’ administrative assistant.  If subjects are identified by a pre-
screening (i.e. chart is prescreened and tagged by the clinical research office) and they are 
interested in the study they will schedule another appointment in the Vision Rehab Service 
research lab at Massachusetts Eye and Ear Infirmary, 243 Charles St., 8th floor.  The 
scheduler/study coordinator/research assistant will inquire about any prior diagnosis of 
dementia or significant cognitive impairment, and if so coordinate the primary caregiver to also 
attend the visit.   
 
Pre-Screening and assent for decisionally impaired:  Approved study staff will administer a short 
cognitive pre-screening (mini-mental state exam, MMSE) to determine if there is any cognitive 
impairment.  The MMSE will not be linked to a study identifier and will be retained for aggregate 

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analysis only.  If score is <18, the individual is not eligible.  If score is 18-23 (may be decisionally 
impaired), an assent process will occur, and consent obtained from the primary caregiver (the 
health care proxy (if one has been named), or the spouse or family member (in that order of 
preference)).   
 
Children: If the study candidate is a child, one parent will sign the consent and children under 14 
will sign the assent and children over 14 and older will sign the consent (unless decisionally 
impaired as determined with the same MMSE criteria).   
 
Consent procedures: The PI has approximately 10 years experience in providing informed 
consent to patients with neurological disorders, and >15 years providing eye care for this 
population.  One of the trained clinical research technicians will perform the informed consent 
in a private room at Massachusetts Eye and Ear. The PI will not be directly involved in the consent 
process and he will not be in the room during signature, to prevent any sense of 
pressure/coercion.  Alternatively, informed consent may be performed over the telephone, to 
limit the face to face time so long as the COVID-19 pandemic is a concern. The study will be 
explained to the potential participant and they will be asked to read (or have read to them) and 
sign the approved informed consent (or assent) form before participation in the study.  
Alternatives to participating will be explained.  They will be given ample opportunity to discuss 
all aspects of the study before signing the form.  A detailed explanation of the interventions and 
how they work will be given, including showing them the devices (pictures of the devices if 
consented on the phone) and allowing them to ask questions.  The study staff will leave the room 
allowing the prospective participant and any family members to discuss in private.  Prospective 
participants will be specifically offered the opportunity to discuss the interventions and the study 
with the PI, their ophthalmologist, and family members/caregivers prior to consenting.  A copy 
of the consent form will be given to the participant. 
 
 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY  
Safeguards will be employed to protect the confidentiality of participant data including the 
following:  Each member of the study team has completed privacy training and information security 
training at Mass Eye and Ear, paper files will be locked in cabinets when not in use, paper files will be 
protected from inappropriate access when in use, mobile computing devices and storage media will be 
locked in cabinets when not in use, computing devices will be protected from inappropriate access when 
in use, research data will be coded using a study identification number that does not include the 
participant’s initials and is not derived from the participant’s identifiable information, the key linking the 
study ID to the participant’s info is available only to the study team, the key will be stored in a locked 
password protected network with access limited to the study members who require access to this 
information, electronic data will be stored on folders only available to the study team.  Devices for video 
recording components of the study will be encrypted and/or password protected where possible and data 
will be promptly transferred and deleted from the device.  All video/image and other data will be de-
identified prior to publication.  We will attempt to capture video/image data so as to only include the 
eyes, which will therefore not be identifiable.  In situations where this is not possible (ie participant 
moves), video/image data will be cropped to reduce the image to eliminate other facial features.  Audio 

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will ultimately be removed from the video files, but may be needed during processing to determine if 
blinks are reflexive or the experimenter has asked the participant to volitionally blink.  De-identified 
cropped videos with sound removed will be published as supplementary data or on a public site such as 
YouTube, and will be used in lectures presenting results of the work.  Participants will be informed that 
their de-identified video recordings may be shared in this manner and ask to check a box on the consent 
form.  Those who decline will not be excluded from participation and this will be emphasized in the 
consent form and verbally by the PI during the consent process.  
 
 
 
14 
DATA HANDLING AND RECORD KEEPING  
 
14.1 
Data Collection and Management Responsibilities  
Data management and collection will be monitored by the PI.  Study staff involved in data collection will 
maintain all training and certifications required by the MGB IRB.   Paper data forms will be stored in a 
locked file cabinet in the vision rehab lab on the 8th floor at Mass Eye and Ear 243 Charles St. Boston MA 
02114, or in or near the PI’s office at Schepens Eye Research Institute, 20 Staniford St.  Boston MA, 02114.  
 
14.2 
Study Records Retention  
Identifiers will be destroyed after publication of the results.  The projected time frame is 3 years 
from the beginning of the study.  Study records in deidenified form will be kept indefinitely.   
 
14.3 
Protocol Deviations  
Protocol deviations and unanticipated problems will be reported following the MGB IRB office policy.   
 
14.4 
Publication and Data Sharing Policy 
Study results will be published at scientific conferences and peer-reviewed journals. Study participants 
will not be identifiable by the data presented within the publications. 
 
16 
CONFLICT OF INTEREST POLICY 
Per MGB Human Protection Program policy, the Principal Investigator and Sub Investigators will 
complete the MGB IRB Conflict of Interest In Research Project Specific Disclosure Forms before 
participating in the Study.   
 
17  
LITERATURE REFERENCES  
1. 
Houston KE, Tomasi M, Yoon M, Paschalis EI.  A Prototype External Magnetic Eyelid 
Device for Blepharoptosis.  Translational Vision Science & Technology. 2014; 3(6):9. 
2. 
Houston KE, Tomasi M, Yoon M, Batalha G, Paschalis EI. An external magnetic device for 
severe bilateral blepharoptosis: proof of concept (abstract). Optom Vis Sci 2015; E-
abstract 15092. 
3. 
Lawrence G, Paschalis EI, Tomasi M, Finch N, Houston KE. A non-invasive magnetic 
system for temporary management of lagophthalmos- proof of concept (abstract). 
Optom Vis Sci 2016;93: E-abstract 16091. 
4. 
Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: 
preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 
16118. 

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5. 
Houston KE, Pachalis EI, Angueira DC, Bronstad PM, Barrett AM, Iaccarino MA. 
Restoration of Vision After Brain Injury Using Magnet Glasses. Am J Phys Med Rehabil 
2017 Apr;96(4):e70-e74.  
6. 
Houston KE, Tomasi M, Armaral C, Finch N, Yoon MK, Paschalis EI.  The Magnetic Levator 
Prosthesis for Temporary Management of Severe Blepharoptosis: Initial Safety and 
Efficacy. Transl Vis Sci Technol, 2018. 7(1): p. 7. 
7. 
Sun ZH, Tian YP, Tan YF, et al. Effectiveness of Kinesio taping on peripheral facial 
paralysis: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 
2020;99(46):e23090. doi:10.1097/MD.0000000000023090