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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new magnetic device designed to assist individuals with lagophthalmos, a condition where the eyelids cannot fully close, potentially leading to eye damage or blindness. The device, called the Temporary Magnetic System for Tarsorrhaphy (MST), aims to close the eyelids safely and effectively using a temporary magnetic system, providing a less invasive alternative to surgery. Potential beneficiaries include those with lagophthalmos and individuals who have recently experienced a corneal abrasion but have no eye infections. As an unphased trial, this study offers patients a unique opportunity to access innovative treatment options before they become widely available.

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 prior data suggests that this magnetic device is safe for treating lagophthalmos?

Research has shown that a temporary magnetic system for tarsorrhaphy (MST) is safe, particularly for individuals with temporary facial paralysis. This system closes the eyelids by attaching magnets to the upper and lower lids. In past studies, this method successfully closed the eyelids in all five cases tested, protecting the cornea, the clear front part of the eye. Additionally, the system is easy to remove if needed, enhancing its safety. No serious side effects have been reported, making it a promising option for those who have trouble closing their eyelids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Magnetic System for Tarsorrhaphy (MST) because it offers a non-invasive alternative to traditional surgical methods for treating lagophthalmos. Unlike existing treatments that involve surgery and can have significant cosmetic drawbacks, the MST uses temporary magnets to help close the eyelids, reducing the risk of dryness and infection without needing anesthesia. This innovative approach not only promises a more comfortable experience for patients but also aims to preserve the natural appearance of the eyelids.

What evidence suggests that this magnetic device is effective for lagophthalmos?

Research shows that magnetic devices can assist people with lagophthalmos, a condition where the eyelids don't fully close. In this trial, participants will use the Temporary Magnetic System for Tarsorrhaphy (MST) to evaluate its effectiveness in providing adequate eyelid closure. Studies have demonstrated that magnetic systems can achieve full eyelid closure in both healthy individuals and those with the condition. Specifically, one study found that attaching magnets to the upper and lower eyelids led to complete closure in every case tested. This suggests that the magnetic system could effectively reduce problems like dryness and infection caused by incomplete eyelid closure. Initial findings also indicate that these devices perform well in real-life situations, although some cases have experienced issues with the body rejecting the device. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

Patients with lagophthalmos

Normal Controls

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

Exclusion Criteria

Individuals with adhesive or tape allergies

I currently have an eye infection.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06291818?draw=2&rank=1

Self-Adhering Magnetic Device to Treat Corneal Exposure | ... Use of a temporary magnetic system for tarsorrhaphy (MST) to provide adequate closure of the eyes for ultimate use in conditions causing lagophthalmos (a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24841731/

Magnetic systems for tarsorrhaphy The magnet system affixed to upper and lower eyelids resulted in complete eyelid closure in 5 of 5 normal controls, while the magnet system affixed to the upper ...

3. withpower.com withpower.com/trial/phase-corneal-exposure-2-2024-e4b31

Magnetic Device for Lagophthalmos 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 ...

4. researchgate.net researchgate.net/publication/262538255_Magnetic_Systems_for_Tarsorrhaphy

Magnetic Systems for Tarsorrhaphy | Request PDF The magnet system affixed to upper and lower eyelids resulted in complete eyelid closure in 5 of 5 normal controls, while the magnet system affixed to the upper ...

5. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/full/10.1002/adrr.202500048

A Proof‐of‐Concept Assessment of a Novel Wearable Eyelid ... Experiments reveal that the proposed concept can achieve complete average eyelid closure across all 12 blinks for each trial at a frequency of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40671431/

Efficacy and Safety of a Magnetic Device for Temporary ... This study developed a feedback-enabled magnetic device for the management of blepharoptosis and conducted a clinical trial to evaluate its efficacy and safety.