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

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.

Conditions

• Facial Nerve Palsy
• Corneal Exposure
• Paralytic Lagophthalmos

Interventions

DEVICE

Polypropylene 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.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Edsel Ing, MD PhD FRCSC · University of Alberta

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-28

Primary Completion

2028-07-31

Completion

2028-07-31

FDA Device

Yes

Countries

• Canada

Study Locations