An interventional study of Magnetic Levator Prosthesis (MLP) and Kinesiotape Frontalis Sling (KTFS) in Blepharoptosis, Ptosis, Eyelid and Myasthenia Gravis, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Treatment
This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).
Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of alloys of neodymium (Nd), iron (Fe) and boron (B)) to restore eyelid movement. The Kinesiotape Frontalis Sling (KTFS), involves the use of tape to help facilitate levator muscle contraction to open the eyelid. Video recordings of spontaneous and volitional blinks will be used to evaluate the effects of each device on eyelid reanimation.
The clinical trial will employ a crossover design in which participants will try each device at home in counterbalanced order with a washout period between. In each period of the crossover, participants will receive training (during study visits at Massachusetts Eye and Ear) in how to apply the device and will then try the device at home for one week with daily follow up by video calls. At the end of the one-week period of home use there will be a study visit at Massachusetts Eye and Ear when the device will be returned and additional video recordings of eye blinks will be made.
At the end of the crossover period, participants will be asked to complete a questionnaire comparing the two devices and to select their preferred device.
Exclusion Criteria:
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) · Device: 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.
Device: Magnetic Levator Prosthesis (MLP) · Device: Kinesiotape Frontalis Sling (KTFS)
Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin.
Kineso Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational therapist to support muscular healing and movement. It is sometimes used on the face in cases of facial palsy or on the eye lid to support the lid in cases of severe blepharoptosis. In such cases it may be attached near the lid margin above the lashes extending up to the forehead skin overlying the frontalis muscle. Alternatively it may be a very short piece attached only along the lid skin. The tape is easily removed.
Interpalpebral Fissure (IPF) During Spontaneous Blink
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.
Time frame: 2 weeks
Interpalpebral Fissure During Resting Open
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.
Time frame: 2 weeks
Proportion of Non-closure During Volitional Blinks
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.
Time frame: 2 weeks
Proportion of Subjects Selecting Each Device
Proportion of subjects selecting either the MLP, the KTFS or neither
Time frame: 6 weeks
Data for this study were collected at Massachusetts Eye and Ear, Boston, MA. Subjects were recruited by flyer and by referral from other ophthalmology clinics, or neurology clinics.
| Milestone | MLP First, KTFS Second | KTFS First, MLP Second |
|---|---|---|
| Started | 9 | 7 |
| Completed | 8 | 7 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| millimeters | Magnetic Levator Prosthesis (MLP) | Kinesiotape Frontalis Sling (KTFS) | Baseline (Sham) |
|---|---|---|---|
| Interpalpebral Fissure (IPF) During Spontaneous Blink | 2.4 (1.5 to 3.7) | 4.1 (2.6 to 6.5) | 1.1 (0.7 to 1.8) |
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.
| millimeters | Magnetic Levator Prosthesis (MLP) | KTFS | Baseline (Sham) |
|---|---|---|---|
| Interpalpebral Fissure During Resting Open | 6.8 (5.2 to 8.4) | 7.0 (5.4 to 8.6) | 3.9 (2.3 to 5.5) |
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.
| Proportion of Non-closure Blinks | Magnetic Levator Prosthesis (MLP) | KTFS | Baseline (Sham) |
|---|---|---|---|
| Proportion of Non-closure During Volitional Blinks | 0.067 | 0.356 | 0.022 |
Proportion of subjects selecting either the MLP, the KTFS or neither
| Participants | Preferred Magnetic Levator Prosthesis (MLP) | Preferred Kinesiotape Frontalis Sling (KTFS) | Preferred Neither Treatment |
|---|---|---|---|
| Proportion of Subjects Selecting Each Device | 7 | 6 | 2 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnetic Levator Prosthesis (MLP) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Kinesiotape Frontalis Sling (KTFS) | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Baseline (Sham) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Magnetic Levator Prosthesis (MLP) | Kinesiotape Frontalis Sling (KTFS) | Baseline (Sham) |
|---|---|---|---|
| Increase in skin erythema scale >3 pointsEye disorders | 0/15 | 2/15 | 0/15 |
| Increase in conjunctival staining >2 pointsEye disorders | 0/15 | 1/15 | 0/15 |
The subject that was lost to follow up did not contribute any data to the analysis. No data was collected at their first study visit and so we felt it was best not to report as part of the baseline demographics.
| Age, Continuous(years) | Participants |
|---|---|
| Median | 61 (55 to 65) |
| Sex: Female, Male(Participants) | Participants |
|---|---|
| Female | 6 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Participants |
|---|---|
| United States | 15 |
| Baseline Interpalpebral Fissure(millimeters) | Participants |
|---|---|
| Mean | 3.89 ± 2.36 |
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