Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Not Applicable

Completed

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

Interventions: Device: Magnetic Levator Prosthesis (MLP)
Device: Kinesiotape Frontalis Sling (KTFS)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MLP first, KTFS second	Magnetic Levator Prosthesis (MLP)	Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
KTFS first, MLP second	Magnetic Levator Prosthesis (MLP)	Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.
MLP first, KTFS second	Kinesiotape Frontalis Sling (KTFS)	Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period.
KTFS first, MLP second	Kinesiotape Frontalis Sling (KTFS)	Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period.

Primary Outcome Measures

Name	Time	Method
Interpalpebral Fissure (IPF) During Spontaneous Blink	2 weeks	The primary outcome was objective measurement of the IPF midpoint height during maximum closing in five spontaneous blinks, captured with a Nikon mirrorless SLR video recording system (Z7II; Nikon USA, Melville, NY, USA), with a visible light source mounted just above the lens, measured manually with ImageJ (National Institutes of Health, Bethesda, MD, USA). Spontaneous blinks are normally incomplete, a behavior that is dependent upon age, gender, task, and environmental demands. Maximum closing was defined as the three points at the base of the blink. Participants were instructed to look at the camera lens and try to relax and behave normally. Recording was stopped after 1 minute or after five spontaneous blinks, whichever came first. Recording always occurred in the same windowless clinical research room with consistent lighting, temperature, humidity, and air flow. The IPF midpoint height during maximum closing in five spontaneous blinks is averaged and reported below.

Secondary Outcome Measures

Name	Time	Method
Interpalpebral Fissure During Resting Open	2 weeks	Resting open IPF was the median between blink-event IPF, measured automatically by a deep learning model for eyelid landmark detection. the IPF midpoint height during resting open was averaged and reported below.
Proportion of Subjects Selecting Each Device	6 weeks	Proportion of subjects selecting either the MLP, the KTFS or neither
Proportion of Non-closure During Volitional Blinks	2 weeks	At the end of recording, participants were instructed to close their eyes completely and open completely three times, representing volitional blink trials. These were evaluated manually with ImageJ. Blinks were classified by a human rater as having complete closure, or not, and then the proportion of non-closure blinks across all subjects was calculated for each condition and reported below.