Clinical Trial: Magnetic Correction of Eye Lid Paralysis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Kevin Houston

Current Primary Outcome: Rating Scale of Skin Integrity [ Time Frame: 2 months ]

Ratings at the beginning and end of treatment will be analyzed for differences.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • National Eye Institute rating scale [ Time Frame: 2 months ]
    Corneal staining scale
  • Visual acuity [ Time Frame: 2 months ]
    Early treatment of diabetic retinopathy study letters on a standard 20 foot visual acuity chart


Original Secondary Outcome:

  • NEI rating scale [ Time Frame: 2 months ]
    Corneal staining scale
  • Visual acuity [ Time Frame: 2 months ]
    ETDRS letters on a standard 20 ft visual acuity chart


Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: October 1, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: March 27, 2017
Last Verified: March 2017