Magnetic Correction of Eye Lid Paralysis

Blepharoptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988856
• Other study ID #: 15-027H
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: May 14, 2019

Study information

• Verified date: October 2020
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Blepharoptosis
• Facial Paralysis
• Lagophthalmos
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
United States	Ophthalmology of Clinical Research Office, Mass Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Kevin Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Scale of Skin Integrity	Ratings at the beginning and end of treatment will be analyzed by calculating the mean and standard deviation of the skin erythema rating across all available time points. The outcome measure is the FDA scale, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry. Range is 0 to 7 with higher numbers being worse skin erythema.	Baseline and up to 32 weeks
Secondary	Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale	Using the National Eye Institute Rating Scale (0 to 3 points with higher being more staining), cases where staining increased more than 2 points or if there was any ulceration, an adverse event was tabulated and summed for each participant over 1 up to 32 weeks of use, depending on how long the participant was followed.	Baseline and up to 32 weeks
Secondary	Change in Visual Acuity	Visual acuity at 20ft before treatment and after 1 week or more. Difference between weekly acuity measures to baseline was calculated and averaged for each subject, and then a group mean and standard deviation calculated.	Baseline and up to 32 weeks