Magnetic Correction of Eye Lid Paralysis



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:5 - Any
Updated:10/12/2018
Start Date:July 2015
End Date:June 2023

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Non-surgical Correction of Eye Lid Paralysis With External Magnet Systems

Objective 1: Determine the safety and feasibility of externally mounted magnets for extended
management of chronic eyelid movement disorders by measuring visual acuity and corneal and
skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the
relative efficacy of external magnetic devices by comparing them to externally mounted lid
weights and ptosis crutches using rating scales and video analysis of blink biomechanics.

Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of
the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions
occur because of a disruption in the normal agonist-antagonist neuro-muscular complex
balance. Generally paralysis of the eyelid or facial muscles is responsible for the
abnormality (the eyelids can close but not open, or open but not close). An external device,
if able to generate an appropriately balanced force, could restore eyelid movement by
performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and
the functioning eyelid closure muscle could overcome the device's force. In prior work the
investigators established proof-of-concept data demonstrating safety and efficacy for
temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest
similar safety for lagophthalmos. This study will expand on this preliminary work to examine
longer wear times, home use, and feasibility for a wider range of eye lid disorders.

Inclusion Criteria:

- Presence of an eyelid movement disorder for at least one eye, 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, age 5 or older.

Exclusion Criteria:

- Absence of an eyelid movement disorder or presence of a corneal ulcer. Those with a
corneal ulcer are at risk for permanent loss of vision and should be managed with
proven methods. Age less than 5, Severe Cognitive impairment defined as Mini-mental
score <18, behaviors consistent with delirium (combinations of disorientation,
hallucinations, delusions, and incoherent speech), or lethargy. These individuals must
be excluded since participation requires competent self-care, reliable responses and
cooperation during fitting of the devices.
We found this trial at
1
site
Boston, Massachusetts 02114
Principal Investigator: Kevin E Houston, O.D., M.Sc.
Phone: 617-573-4437
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mi
from
Boston, MA
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