Magnetic Device for Lagophthalmos

Overseen By Pete Setabutr, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Adhesive allergies, Metal in eye, Infections

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Magnetic Device for Lagophthalmos treatment?

Research shows that implanting magnets in the eyelids can help restore eyelid function in patients with facial nerve paralysis, allowing them to close their eyes properly. This method is simple, reversible, and does not alter the eye's appearance or vision. ^{1 2 3 4 5}

Is the Magnetic Device for Lagophthalmos safe for humans?

The magnetic device for lagophthalmos has been used in humans with generally good results, but there have been some cases of rejection due to poor implantation technique. It is considered safe for use, especially in cases of reversible facial paralysis, and can be easily reversed if needed. ^{1 2 3 6 7}

How is the Magnetic Device for Lagophthalmos treatment different from other treatments?

The Magnetic Device for Lagophthalmos is unique because it uses magnets implanted in the eyelids to help restore eyelid function without altering the shape or size of the eyelid opening, unlike traditional surgical methods. This approach is simple, reversible, and can be performed on an outpatient basis, making it a novel alternative to more invasive procedures. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-80 with lagophthalmos, a condition where the eyelid cannot close properly, leading to corneal exposure. It's also open to those who've recently had a corneal abrasion without infection. People with allergies to adhesives or tape, metal fragments in their eye from past activities like welding, or current eye infections can't participate.

Inclusion Criteria

I recently had a scratched cornea but no signs of infection.

Patients with lagophthalmos

Normal Controls

Exclusion Criteria

Individuals with adhesive or tape allergies

Individuals with a history of metal pieces/shavings embedded in the eye (such as from welding or metalworking)

I currently have an eye infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a temporary magnetic system for tarsorrhaphy to provide adequate closure of the eyes

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Temporary Magnetic System for Tarsorrhaphy (MST)

Trial Overview The study is testing a new temporary magnetic system (MST) designed to help control eyelid position and treat paralytic lagophthalmos which can cause corneal ulcers and potentially blindness. The device uses improved magnetic technology that has shown promise in preliminary studies.

Participant Groups

Group I: Assess the performance of this novel eyelid closure device in vivo Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

Magnet implantation in the eyelids of 29 patients with Keratopathia due to lagophthalmos was found to be a safe and effective alternative to lateral tarsorrhaphy, preserving the shape and size of the eyelid opening and visual field.

The procedure is technically simple, easily reversible if nerve function improves, and yielded good subjective results from the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience with magnet implantation in lagophthalmos (author's transl)]. Riehm, E., Hinzpeter, EN.[2009]

The study reports on 8 cases of lagophthalmos caused by facial nerve paralysis, highlighting the serious risk of eye diseases due to the inability to close the eyelid.

Implanting permanent magnets in the eyelid rims effectively restored eyelid function, and the procedure can be performed as an outpatient operation, showing promising results after 2.5 years of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A simple method of restoring lidfunction in facial nerve paralysis with permanent magnets (author's transl)]. Momma, WG., Biermann, B.[2009]

A study tested six different gold eyelid weights at two magnetic strengths (0.5-tesla and 1.5-tesla) to see if they would move during MRI scans.

The results showed no deflection of the gold eyelid weights, indicating that patients with these weights are safe during MRI examinations and at no risk of damage from the imaging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of magnetic resonance imaging fields on gold eyelid loads. Canady, JW., Meine, J., Thompson, SA., et al.[2004]

Implanting permanent magnets in the eyelid to treat lagophthalmos led to frequent severe complications, particularly skin ulcers and magnet expulsion.

The study suggests that the current method of using permanent magnets needs to be revised to improve safety and effectiveness in treating lagophthalmos.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Problems in the implantation of permanent magnets of the treatment of lagophthalmos (author's transl)]. Piffaretti, JM., Perrinjaquet, M., Zurbuchen, M.[2009]

In a study of 88 patients with optic nerve atrophy, magnetotherapy improved vision acuity in 50% of cases, particularly benefiting those with low initial acuity, as the number of patients achieving 0.2 diopters increased significantly after treatment.

Magnetotherapy not only enhanced visual function but also improved ocular blood flow and reduced conduction time in the visual pathways, with the best results observed after 10 treatment sessions, suggesting a potential for long-term stabilization with repeated courses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of magnetotherapy in optic nerve atrophy. A preliminary study]. Zobina, LV., Orlovskaia, LS., Sokov, SL., et al.[2006]

The novel parylene-C coated samarium cobalt implants demonstrated excellent biocompatibility in vitro, showing high cell viability (82.0%) and minimal inflammatory response, indicating safety for use in patients with unilateral lagophthalmos.

The implant successfully restored blinking functionality, achieving a reproducible blink at 100 ms with full corneal coverage, which could significantly enhance the quality of life for individuals with eyelid paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blink detection and magnetic force generation for correction of lagophthalmos, with specific regard to implant compatibility testing. Coussa, RG., Lomis, N., Antaki, F., et al.[2022]

In a study of 114 patients with unilateral and 3 with bilateral lagophthalmos due to facial palsy, the implantation of permanent magnets in the eyelids resulted in satisfactory to good eyelid function, providing complete eye protection in most cases.

Rejection of the magnets occurred in 15 cases, primarily due to poor implantation techniques, suggesting that proper surgical methods are crucial for the success of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Five years experience with lid magnet implantation for paretic lagophthalmos (author's transl)]. Mühlbauer, WD.[2009]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Experience with magnet implantation in lagophthalmos (author's transl)]. [2009]

2. Germany pubmed.ncbi.nlm.nih.gov

[A simple method of restoring lidfunction in facial nerve paralysis with permanent magnets (author's transl)]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of magnetic resonance imaging fields on gold eyelid loads. [2004]

4. Germany pubmed.ncbi.nlm.nih.gov

[Problems in the implantation of permanent magnets of the treatment of lagophthalmos (author's transl)]. [2009]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effectiveness of magnetotherapy in optic nerve atrophy. A preliminary study]. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Blink detection and magnetic force generation for correction of lagophthalmos, with specific regard to implant compatibility testing. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Five years experience with lid magnet implantation for paretic lagophthalmos (author's transl)]. [2009]