Trial Outcomes & Findings for Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis (NCT NCT04678115)

Last Updated: 2025-04-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

2 weeks

Results posted on

2025-04-22

Participant Flow

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.

One candidate was ruled as ineligible at a pre-screening visit due to lack of blepharoptosis.

Participant milestones

Participant milestones
Measure	MLP First, KTFS Second Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP device. 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. Kinesiotape Frontalis Sling (KTFS): 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.	KTFS First, MLP Second Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP device. 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. Kinesiotape Frontalis Sling (KTFS): 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.
Overall Study STARTED	9	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MLP First, KTFS Second Participants in this arm will receive the MLP in the first period of the crossover and the KTFS in the second period. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP device. 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. Kinesiotape Frontalis Sling (KTFS): 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.	KTFS First, MLP Second Participants in this arm will receive the KTFS in the first period of the crossover and the MLP in the second period. This was a cross-over study in which participants received each the Magnetic Levator Prosthesis (MLP) and the Kinesiotape Frontalis Sling (KTFS) devices in counterbalanced order with a washout period between the two interventions. Additionally, the participants also completed a training period for each device prior to the week of at home use, where participants completed baseline assessments with each respective Device and during the MLP training they also underwent assessment using a Sham MLP device. 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. Kinesiotape Frontalis Sling (KTFS): 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.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=15 Participants Baseline characteristics were calculated for the entire group.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
Baseline Interpalpebral Fissure	3.89 millimeters STANDARD_DEVIATION 2.36 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Magnetic Levator Prosthesis (MLP) n=15 Participants Data from when the participants were wearing the MLP.	Kinesiotape Frontalis Sling (KTFS) n=15 Participants Data from when participants were wearing the KTFS.	Baseline (Sham) n=15 Participants Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect.
Interpalpebral Fissure (IPF) During Spontaneous Blink	2.4 millimeters Interval 1.5 to 3.7	4.1 millimeters Interval 2.6 to 6.5	1.1 millimeters Interval 0.7 to 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnetic Levator Prosthesis (MLP) n=15 Participants Data from when the participants were wearing the MLP.	Kinesiotape Frontalis Sling (KTFS) n=15 Participants Data from when participants were wearing the KTFS.	Baseline (Sham) n=15 Participants Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect.
Interpalpebral Fissure During Resting Open	6.8 millimeters Interval 5.2 to 8.4	7.0 millimeters Interval 5.4 to 8.6	3.9 millimeters Interval 2.3 to 5.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Magnetic Levator Prosthesis (MLP) n=15 Participants Data from when the participants were wearing the MLP.	Kinesiotape Frontalis Sling (KTFS) n=15 Participants Data from when participants were wearing the KTFS.	Baseline (Sham) n=15 Participants Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect.
Proportion of Non-closure During Volitional Blinks	0.067 Proportion of Non-closure Blinks	0.356 Proportion of Non-closure Blinks	0.022 Proportion of Non-closure Blinks

SECONDARY outcome

Timeframe: 6 weeks

Population: All 15 participants were asked to chose which device they liked better, or no device. They were still masked to which was the novel/experimental treatment.

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

Outcome measures

Outcome measures
Measure	Magnetic Levator Prosthesis (MLP) n=15 Participants Data from when the participants were wearing the MLP.	Kinesiotape Frontalis Sling (KTFS) n=15 Participants Data from when participants were wearing the KTFS.	Baseline (Sham) n=15 Participants Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect.
Proportion of Subjects Selecting Each Device	7 Participants	6 Participants	2 Participants

Adverse Events

Magnetic Levator Prosthesis (MLP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Kinesiotape Frontalis Sling (KTFS)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Baseline (Sham)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Magnetic Levator Prosthesis (MLP) n=15 participants at risk Data from when the participants were wearing the MLP.	Kinesiotape Frontalis Sling (KTFS) n=15 participants at risk Data from when participants were wearing the KTFS.	Baseline (Sham) n=15 participants at risk Data from when participants were wearing a sham MLP device. Data acts as a baseline + placebo effect.
Eye disorders Increase in skin erythema scale >3 points	0.00% 0/15 • 8 weeks	13.3% 2/15 • Number of events 2 • 8 weeks	0.00% 0/15 • 8 weeks
Eye disorders Increase in conjunctival staining >2 points	0.00% 0/15 • 8 weeks	6.7% 1/15 • Number of events 1 • 8 weeks	0.00% 0/15 • 8 weeks

Additional Information

Kevin Houston

VA Central Western Massachusetts

Phone: 781-588-7674

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place