Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06895902

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

Led by University of Alberta · Updated on 2025-05-25

10

Participants Needed

2

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older with facial nerve transection or paralytic lagophthalmos that has not improved after 6 weeks
Not Eligible

You will not qualify if you...

  • Patients unable to tolerate awake eyelid surgery under local anesthetic

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H 3V9

Not Yet Recruiting

2

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5J 0N3

Actively Recruiting

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Research Team

E

Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA

CONTACT

E

Erin Childs, MOA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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