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Paralytic LagophthalmosNCT06291818

Self-Adhering Magnetic Device to Treat Corneal Exposure

A study testing temporary magnetic system for tarsorrhaphy (MST) in people with Paralytic Lagophthalmos and Corneal Exposure, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Paralytic Lagophthalmos, Corneal Exposure
What is being tested?
temporary magnetic system for tarsorrhaphy (MST)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
17 Apr 2024to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Van Ann Tran, MD contact

312-996-9120

annqtran@uic.edu

United States1 site, 1 recruiting
  • University of Illinois - Specialty Care Building

    Chicago, Illinois, 60612

    Van Ann Tran, MD, 312-996-9120

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Patients who suffer from lagophthalmos cannot close their eyelids completely. In paralytic lagophthalmos, this physical incapability is caused by paralysis of the seventh cranial nerve. Causes of this paralysis include Bell's palsy, vascular accidents, injury, trauma, and tumors. Complications can include irritation, ulceration, and perforation of the cornea; exposure and neurotrophic keratopathy; persistent epithelial defects; and potential blindness.

Due to the myriad causes and complications, management of paralytic lagophthalmos has proven difficult, and existing methods of treatment each have shortcomings. Initial, mainly conservative, and supportive, management includes use of ocular lubricants, moisture chambers, eyelid taping, adhesive eyelid weights, bandage contact lenses, botulinum toxin, and hyaluronic-acid gel fillers. Ephemeral benefits and low patient compliance due to frequency of application often leave these treatments destined for failure.

As such, surgical intervention is subsequently necessary, although surgical methods have been shown to be flawed as well. Tarsorrhaphies are static surgical procedures in which the eyelids are partially or completely sewn together to narrow the palpebral fissure. Although effective in healing corneal lesions preventing excessive corneal exposure, tarsorrhaphies often require repeated suturing, which both increases inflammatory response of the eyelids to the sutures and, much to patients' discontent, decreases cosmesis. Loosening of the sutures, restricted peripheral vision, and trichiasis are additional potential negative outcomes. In another static procedure known as "lid loading", gold or platinum weights are implanted into the eyelid. However, these are susceptible to extrusion and can cause blepharoptosis (drooping of the upper eyelid), allergic reactions, and-when the patient is supine-incomplete eyelid closure. Cartilage grafts as weights fail to treat severe cases of paralytic lagophthalmos. Palpebral springs, used in a dynamic procedure, require numerous revisions and are thus impractical for long-term benefits.

Certain clinical situations may develop into paralytic lagophthalmos and cause downstream effects later on. These clinical conditions include corneal abrasions, or scratches of the cornea, as well as a surgical procedure called eye enucleation, or the surgical removal of the eye for other reasons (typically but not always replaced with a glass or prosthetic eye). Because these conditions or procedures may be associated with paralytic lagophthalmos, improving eyelid closure before development of permanent lagophthalmos may be critical in preventing future corneal ulcers and worse conditions of the eye.

In addition to conservative and surgical approaches to management of paralytic lagophthalmos and the resulting exposure keratopathy, clinicians and researchers have also utilized magnets for eyelid closure. First suggested in 1957, this method grew in favor in the decades to follow, as several major studies were published indicating its success in both cosmetics and functionality. However, due to limited technology and moderate amount of magnet extrusion, this method was temporarily abandoned. Today, cutting-edge technology has produced smaller magnets with stronger magnetic fields, prompting experts to revisit the use of magnets to facilitate eyelid closure. In a study conducted by Barmettler magnets embedded in biocompatible molds were affixed in two configurations: 1) to the upper and lower eyelids, or 2) to the upper eyelid and to the lower rim of the frame of a pair of eyeglasses. Initial model and patient testing were promising, but questions remain regarding the strength of magnets in disease states, size of the silicone mold, and implantability as opposed to external affixation.

Being tested
temporary magnetic system for tarsorrhaphy (MST)
Medical subject headings
Lagophthalmos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06291818
Study groupRoleWhat they receive
Assess the performance of this novel eyelid closure device in vivoOtherThe 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.
Receives: Device: temporary magnetic system for tarsorrhaphy (MST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start17 Apr 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
temporary magnetic system for tarsorrhaphy (MST)
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06291818
Sponsor's protocol ID
2023-0917
Status last verified
May 2026
First submitted
26 Jan 2024
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing temporary magnetic system for tarsorrhaphy (MST) in people with Paralytic Lagophthalmos and Corneal Exposure, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Van Ann Tran, MD (312-996-9120, annqtran@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with success of a temporary magnetic system for tarsorrhaphy (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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