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Magnetic Correction of Eye Lid Paralysis

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ClinicalTrials.gov Identifier: NCT02988856
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Kevin Houston, Massachusetts Eye and Ear Infirmary

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.

Condition or disease Intervention/treatment Phase
Blepharoptosis Lagophthalmos Facial Paralysis Device: Magnetic lid system Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-surgical Correction of Eye Lid Paralysis With External Magnet Systems
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Experimental: Magnetic lid system
All participants will trial a commercially available device and an experimental magnetic device.
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.
Other Name: Magnetic Levator and Magnetic Orbicularis




Primary Outcome Measures :
  1. Rating Scale of Skin Integrity [ Time Frame: 2 months ]
    Ratings at the beginning and end of treatment will be analyzed for differences.


Secondary Outcome Measures :
  1. National Eye Institute rating scale [ Time Frame: 2 months ]
    Corneal staining scale

  2. Visual acuity [ Time Frame: 2 months ]
    Early treatment of diabetic retinopathy study letters on a standard 20 foot visual acuity chart



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988856


Contacts
Contact: Kevin E Houston, OD 617-912-2525 kevin_houston@meei.harvard.edu
Contact: Jordyn Hanover, BA 617-912-2505 jordyn_hanover@meei.harvard.edu

Locations
United States, Massachusetts
Ophthalmology of Clinical Research Office, Mass Eye and Ear Recruiting
Boston, Massachusetts, United States, 021141
Contact: Lelia foster    617-573-4437    lelia_foster@meei.harvard.edu   
Contact: Kevin Houston    617-912-2525    kevin_houston@meei.harvard.edu   
Principal Investigator: Kevin E Houston, O.D., M.Sc.         
Sponsors and Collaborators
Kevin Houston
Investigators
Principal Investigator: Kevin E Houston, OD Massachusetts Eye and Ear

Responsible Party: Kevin Houston, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02988856     History of Changes
Other Study ID Numbers: 15-027H
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Paralysis
Facial Paralysis
Bell Palsy
Blepharoptosis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Eyelid Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases