Trial Outcomes & Findings for Magnetic Correction of Eye Lid Paralysis (NCT NCT02988856)

Last Updated: 2020-10-30

Results Overview

Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Baseline and up to 32 weeks

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Magnetic Lid System Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Correction of Eye Lid Paralysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnetic Lid System n=11 Participants All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Age, Continuous	52 years STANDARD_DEVIATION 18 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and up to 32 weeks

Population: Erythema rating in participants who had worn the MLP for 1 to 32 weeks. All the ratings each subject had across all their visits were averaged, and then a group average and std dev calculated.

Outcome measures

Outcome measures
Measure	Magnetic Lid System n=9 Participants All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Rating Scale of Skin Integrity	0.3 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and up to 32 weeks

Population: Participants with ptosis wearing the MLP for 1 or more weeks

Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.

Outcome measures

Outcome measures
Measure	Magnetic Lid System n=9 Participants All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale	1 Participants

SECONDARY outcome

Timeframe: Baseline and up to 32 weeks

Population: Participants who wore the MLP for 1 week or more

Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.

Outcome measures

Outcome measures
Measure	Magnetic Lid System n=7 Participants All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Change in Visual Acuity	0.03 LogMAR Standard Deviation 0.08

Adverse Events

Magnetic Lid System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Magnetic Lid System n=11 participants at risk All participants will trial a commercially available device and an experimental magnetic device. Magnetic lid system: Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
Skin and subcutaneous tissue disorders Skin Erythema	18.2% 2/11 • Number of events 2 • 1 week
Eye disorders Corneal staining	9.1% 1/11 • Number of events 1 • 1 week

Additional Information

Kevin Houston

Massachusetts Eye and Ear

Phone: 617-573-4177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place