Self-Adhering Magnetic Device to Treat Corneal Exposure

NCT06291818 | Recruiting

• 1 other identifier: 2023-0917
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position.

Conditions

Paralytic Lagophthalmos; Corneal Exposure

Outcome Measures

Primary Outcomes (1)

• Number of participants with success of a temporary magnetic system for tarsorrhaphy

  Use of a temporary magnetic system for tarsorrhaphy (MST) to provide adequate closure of the eyes for ultimate use in conditions causing lagophthalmos (a disorder in eyelid closure)

  through study completion, an average of 3 years

Study Arms (1)

Assess the performance of this novel eyelid closure device in vivo

OTHER

The primary goal of this study is to determine the feasibility and success of a temporary magnetic system for tarsorrhaphy (MST) to provide adequate closure of the eyes for ultimate use in conditions causing lagophthalmos (a disorder in eyelid closure). In this disorder, people are unable to sufficiently cover their cornea (the front of the eye), which can lead to dryness, infection, scarring and even blindness. Current therapies are invasive, involving local anesthesia and surgeries, and have a negative cosmetic impact.

Device: temporary magnetic system for tarsorrhaphy (MST)

Interventions

temporary magnetic system for tarsorrhaphy (MST) DEVICE

cutting-edge technology has produced smaller magnets with stronger magnetic fields, prompting experts to revisit the use of magnets to facilitate eyelid closure

Assess the performance of this novel eyelid closure device in vivo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 18-80 years old.
• Patients with recent corneal abrasion and no signs of infection in the examination
• Patients with lagophthalmos
• Normal Controls

You may not qualify if:

• Individuals with adhesive or tape allergies.
• Individuals with a history of metal pieces/shavings embedded in the eye (such as from welding or metalworking)
• Individuals with eye infections

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois - Specialty Care Building

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Lagophthalmos

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Eyelid Diseases

Central Study Contacts

Pete Setabutr, MD

CONTACT

312-996-9120

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Oculoplastic & Reconstructive Surgery Service Director, Millennium Park Eye Center

Model Details: temporary magnetic system for tarsorrhaphy (MST)

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: March 4, 2024
• Study Start: April 17, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)