Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06291818 |
| Other study ID # |
2023-0917 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 17, 2024 |
| Est. completion date |
April 1, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Illinois at Chicago |
| Contact |
Pete Setabutr, MD |
| Phone |
312-996-9120 |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
