Recruiting
Early Phase 1

Suture Lid Spring

Sponsor:

University of Alberta

Code:

NCT06895902

Conditions

Facial Nerve Palsy

Corneal Exposure

Paralytic Lagophthalmos

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos

Study Details

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

Study ID

NCT06895902

Start date

Apr 28, 2025

Status verified date

May, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Placement of suture lid spring

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

Interventions

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.

Primary outcome measure

  • Primary outcome [ Time Frame: within the first 2 weeks. ]

Central Contacts and Locations

Central contacts

Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA

6472930155ed.ing@ualberta.ca

Locations

Eye Institute of Alberta, Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5J 0N3

Contacts

Edsel Ing, MD PhD FRCSC MPH MEd MIAD MBA

16472930155ed.ing@ualberta.ca

Principal Investigator:

Edsel Ing, MD PhD

More Information

Sponsor

University of Alberta

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Paralytic lagophthalmos

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-02.