Suture Lid Spring for Facial Nerve Palsy
(SESPL Trial)

Overseen ByErin Childs, MOA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alberta

Disqualifiers: Unable to tolerate local anesthetic

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Polypropylene Suture Eyelid Spring for facial nerve palsy?

Research shows that eyelid springs, similar to the Polypropylene Suture Eyelid Spring, have been effective in helping 83% of patients with facial nerve paralysis regain and maintain eyelid function, preventing corneal complications and maintaining vision.¹ ² ³ ⁴ ⁵

Is the Suture Lid Spring for Facial Nerve Palsy safe for humans?

The use of eyelid springs in patients with facial nerve paralysis has been studied, showing that 83% of patients successfully regained eyelid function with minimal complications over an average follow-up of 3 years. The most common issue was loosening of the spring, which was minimized with a surgical modification.¹ ² ⁶ ⁷ ⁸

How is the Suture Lid Spring treatment unique for facial nerve palsy?

The Suture Lid Spring treatment is unique because it uses a polypropylene suture to create an eyelid spring that helps restore eyelid function in patients with facial nerve palsy. This approach provides corneal protection and maintains vision by allowing some eyelid movement, and it can be adjusted without surgery, which is different from other methods like gold weights or open wire springs.¹ ² ³ ⁴ ⁹

What is the purpose of this trial?

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.

Research Team

Edsel Ing, MD PhD FRCSC

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for patients with permanent facial nerve palsy, such as Bell's Palsy, who can't blink properly. This affects their eye health and vision. Suitable candidates are those looking for an alternative to constant eye lubrication, patching, or surgeries that have cosmetic and functional downsides.

Inclusion Criteria

I am an adult with unimproved facial nerve or eyelid paralysis after 6 weeks.

Exclusion Criteria

I cannot undergo eyelid surgery with just local anesthesia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Force Determination

Determine the amount of force required to close the lids using prolene suture loops

Not specified

Cadaver Study

Determine optimal anatomic placement of the suture for human studies using cadavers

Not specified

Human Studies

Short to long-term placement of the prolene loop in patients with lagophthalmos to assess benefits

1 month

Post-operative checks at 1 week, 1 month, 2 months, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

Polypropylene Suture Eyelid Spring

Trial Overview The study tests a new eyelid spring made from polypropylene sutures designed to help close the eyelids of people with paralytic lagophthalmos. It aims to be less invasive than current treatments like gold weights or metal springs and doesn't attach to bone.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Placement of suture lid springExperimental Treatment1 Intervention

Instead of tying tissue with the surgical suture (polypropylene) that is normally used in lid surgery we will make a loop out of the suture and place it underneath the eyelid skin to see if it will help with eyelid closure in patients with facial nerve palsy. There is no placebo or comparison group