Clinical trial NCT02988856: Magnetic Correction of Eye Lid Paralysis
Official title: Non-surgical Correction of Eye Lid Paralysis With External Magnet Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharoptosis
Lagophthalmos
Facial Paralysis
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rating Scale of Skin Integrity
timeFrame: Baseline and up to 32 weeks
Secondary outcomes:
measure: Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale
timeFrame: Baseline and up to 32 weeks
measure: Change in Visual Acuity
timeFrame: Baseline and up to 32 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmology of Clinical Research Office, Mass Eye and Ear
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Kevin E Houston, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh NK, Paschalis EI, Tomasi M, Rizzo JF, Houston KE. The boston blink-netic project: preliminary outpatient feasibility results (abstract). Optom Vis Sci 2016;93: E-abstract 16118.