Magnetic Correction of Eye Lid Paralysis

NCT02988856 | Completed Results

• 1 other identifier: 15-027H
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharoptosis; Lagophthalmos; Facial Paralysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Count of Participants With Adverse Corneal Events Based on National Eye Institute Rating Scale

  Baseline and up to 32 weeks

• Change in Visual Acuity

  Baseline and up to 32 weeks

Study Arms (1)

Magnetic lid system

EXPERIMENTAL

All participants will trial a commercially available device and an experimental magnetic device.

Device: Magnetic lid system

Interventions

Magnetic lid system DEVICE

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.

Also known as: Magnetic Levator and Magnetic Orbicularis

Magnetic lid system

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kevin Houston: lead

Study Sites (1)

Ophthalmology of Clinical Research Office, Mass Eye and Ear

Boston, Massachusetts, 021141, United States

Location

Related 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.

  RESULT

MeSH Terms

Conditions

Blepharoptosis; Lagophthalmos; Facial Paralysis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Eye Manifestations; Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kevin Houston
• Organization: Massachusetts Eye and Ear

kevin_houston@meei.harvard.edu

617-573-4177

Study Officials

• Kevin E Houston, OD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: December 9, 2016
• Study Start: July 1, 2015
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)