Trial Outcomes & Findings for Clinical Trial to Improve the Magnetic Levator Prosthesis (NCT NCT03818204)
NCT ID: NCT03818204
Last Updated: 2025-06-13
Results Overview
Change in interpalpebral fissure (resting open) at 5 different force settings of the rotatable adjustable force system.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
6 minutes, 1 minute for each rotation position.
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
1-ABCDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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2-BCDAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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3-CDABE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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4-DABCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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5-DCBAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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6-CBADE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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7-BADCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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8-ADCBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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9-ACDBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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10-BDACE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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11-CABDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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12-DBCAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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13-BACDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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14-CBDAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
15-DCABE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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16-ADBCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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17-BCADE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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18-CDBAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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19-DACBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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Overall Study
COMPLETED
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1
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1
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1
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1
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0
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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1
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1
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1
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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1
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1
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0
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0
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0
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Reasons for withdrawal
| Measure |
1-ABCDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
2-BCDAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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3-CDABE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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4-DABCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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5-DCBAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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6-CBADE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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7-BADCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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8-ADCBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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9-ACDBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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10-BDACE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
11-CABDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
12-DBCAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
13-BACDE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
14-CBDAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
15-DCABE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
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16-ADBCE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
17-BCADE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
18-CDBAE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
19-DACBE
Where A=0 degrees, B=30 degrees, C=60 degrees, and D=90 degrees, and E=180 degrees.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Could not close eye due to impaired facial nerve.
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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Overall Study
Physician Decision
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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Baseline Characteristics
One participant was screened and enrolled twice at different time points but was ultimately removed both times because of an impaired facial nerve. Another participant was removed because of difficulties with communication and a self-inflicted corneal abrasion.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=19 Participants
The purpose of the experimental group is to test the intervention. Participants will have their acuity measured (refraction as needed), slit lamp with Nafl \& NEI scale, visual functioning questionnaire (VFQ), cognitive assessment (MOCA).The eye lid will be prepped and video recorded.The masked clinical staff will then apply the polarized magnets and perform a number of measurements to ascertain effectiveness of intervention.
-Intervention - Magnetic Levator Prosthesis (MLP)
|
Control/Normal Vision Group
The purpose of the normal vision group is to test the experimental setup prior to enrolling ptosis patients. If the measurements of the normal vision group are found to be non-different to the experimental group, the data will be pooled.
-Intervention - Magnetic Levator Prosthesis (MLP)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=16 Participants • One participant was screened and enrolled twice at different time points but was ultimately removed both times because of an impaired facial nerve. Another participant was removed because of difficulties with communication and a self-inflicted corneal abrasion.
|
—
|
51 years
n=16 Participants • One participant was screened and enrolled twice at different time points but was ultimately removed both times because of an impaired facial nerve. Another participant was removed because of difficulties with communication and a self-inflicted corneal abrasion.
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
—
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
—
|
10 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
—
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=19 Participants
|
—
|
2 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
—
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=19 Participants
|
—
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=19 Participants
|
—
|
16 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
—
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
—
|
0 Participants
n=19 Participants
|
|
Baseline Interpalpebral Fissure
|
4.7 millimeters
STANDARD_DEVIATION 2.0 • n=19 Participants
|
—
|
4.7 millimeters
STANDARD_DEVIATION 2.0 • n=19 Participants
|
PRIMARY outcome
Timeframe: 6 minutes, 1 minute for each rotation position.Change in interpalpebral fissure (resting open) at 5 different force settings of the rotatable adjustable force system.
Outcome measures
| Measure |
Experimental Group MLP 30 Degree Orientation
n=16 Participants
Subjects with ptosis wearing the MLP with force set at the 30 degree polarization angle.
|
Experimental Group Baseline
n=16 Participants
Subjects with ptosis not wearing any device.
|
Experimental Group MLP 0 Degree Orientation
n=16 Participants
Subjects with ptosis wearing the MLP with force set at the 0 degree polarization angle.
|
Experimental Group MLP 60 Degree Orientation
n=16 Participants
Subjects with ptosis wearing the MLP with force set at the 60 degree polarization angle.
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Experimental Group MLP 90 Degree Orientation
n=16 Participants
Subjects with ptosis wearing the MLP with force set at the 90 degree polarization angle.
|
Experimental Group MLP 180 Degree Orientation
n=16 Participants
Subjects with ptosis wearing the MLP with force set at the 180 degree polarization angle.
|
|---|---|---|---|---|---|---|
|
Change in Interpalpebral Fissure During Eye Opening
|
6.2 millimeters
Interval 5.2 to 7.1
|
4.5 millimeters
Interval 3.8 to 5.3
|
6.9 millimeters
Interval 6.0 to 7.9
|
6.3 millimeters
Interval 5.8 to 7.1
|
6.4 millimeters
Interval 5.9 to 7.6
|
7.1 millimeters
Interval 6.2 to 8.1
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place