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

NCT06895902 | Recruiting Early Phase 1 FDA Device

• 1 other identifier: Pro00149272
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Paralytic lagophthalmos

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Amount of lid closure in millimetres

  within the first 2 weeks.

Study Arms (1)

Placement of suture lid spring

EXPERIMENTAL

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

Device: Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos

Interventions

Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos DEVICE

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

Placement of suture lid spring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unable to tolerate awake eyelid surgery under local anesthetic.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

NOT YET RECRUITING

Eye Institute of Alberta, Royal Alexandra Hospital

Edmonton, Alberta, T5J 0N3, Canada

RECRUITING

MeSH Terms

Conditions

Bell Palsy; Lagophthalmos

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Manifestations; Eye Diseases; Eyelid Diseases

Study Officials

• Edsel Ing, MD PhD FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA

CONTACT

6472930155; ed.ing@ualberta.ca

Erin Childs, MOA

CONTACT

7807358784; erin.childs@ahs.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-masked surgical intervention

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 26, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)