RecruitingEarly Phase 1NCT06895902

Suture Lid Spring for Lid Closure in Patients With Facial Nerve Palsy

Suture Eyelid Spring for Eyelid Closure in Patients With Facial Nerve Palsy


Sponsor

University of Alberta

Enrollment

10 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The eyelids protect the cornea and eyelid closure is essential to ocular health and clear vision. Patients with permanent Bells palsy or facial nerve palsy from other reasons such as tumours or trauma may be unable to blink and protect their cornea. Irreversible visual loss can occur if the cornea is not kept lubricated. Current treatment options for patients whose eyelid blink does not recover include lubricating the eye every hour or two with drops and lubricating ointment at night, patching the eye closed, sewing parts of the eyelid together (tarsorrpahy), upper lid gold weight or a dental wire spring. It is inconvenient to lubricate the cornea constantly, and the lubricating drops and ointment usually cost more than $80.00 per month. Lubrication often blurs vision, because the patient must look through a film. Patching the eye closed and tarsorraphy deprives the patient of peripheral vision, can impede social interaction, and is objectionable cosmetically. Upper-lid gold weights can be placed underneath the eyelid skin and work by gravity. A gold weight will only work when the patient initiates a forced blink. Gold weights may not work when the patient is lying down because there is no gravity to assist lid closure. The eyelid skin is the thinnest skin in the body and can extrude through the skin over time. Eyelid springs made of metal dental wire exist but are not frequently used because they often extrude through the thin eyelid skin. Also, dental wire springs require attachment to the bone near the side of the eye. It is not uncommon that dental wire springs have to be removed or replaced. The investigators propose a new spring to close the eyelid made out of the surgical stitches (sutures) commonly used in medicine and eyelid surgery. The stitch will be made into a custom shape and attached underneath the skin near the centre of the lid, without attachment to the bone. Upper lid gold weights, dental wire springs, and our proposed suture spring are all foreign bodies and can all become infected or extrude through the skin. Because the suture spring is thinner than a gold weight and because it does not have sharp edges like a metal spring, there should be less risk of extrusion. The suture spring will lose its elasticity over time and will require replacement.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops and tests a new type of eyelid spring made from a surgical suture (a type of medical thread with natural elasticity) to help people with facial nerve palsy who cannot close their eyes, putting their corneas at risk of drying out and permanent damage. Current options like gold weights and metal springs have drawbacks including the need for gravity to work or risk of pushing through the thin eyelid skin, and the suture spring aims to provide a thinner, smoother alternative that works whether the patient is upright or lying down. Adults 18 and older with confirmed facial nerve palsy causing inability to close the eye (paralytic lagophthalmos) that has not improved after 6 weeks may be eligible. Participation involves a minor surgical procedure under local anesthetic to place the suture spring under the eyelid skin, with follow-up assessments at 1 week, 1, 2, 6, and 12 months. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPolypropylene Suture Eyelid Spring for Paralytic Lagophthalmos

The polypropylene loop eyelid suture spring will be centrally placed without fixation to the bone unlike a metal lid spring.


Locations(2)

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, Canada

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, Canada

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NCT06895902


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