NCT06895902 Suture Lid Spring for Lid Closure in Patients With Facial Nerve Palsy
| NCT ID | NCT06895902 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alberta |
| Condition | Facial Nerve Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-04-28 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Edsel Ing, MD PhD FRCSC
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06895902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Facial Nerve Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06895902 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06895902 currently recruiting?
Yes, NCT06895902 is actively recruiting participants. Contact the research team at ed.ing@ualberta.ca for enrollment information.
Where is the NCT06895902 trial being conducted?
This trial is being conducted at Edmonton, Canada, Edmonton, Canada.
Who is sponsoring the NCT06895902 clinical trial?
NCT06895902 is sponsored by University of Alberta. The principal investigator is Edsel Ing, MD PhD FRCSC at University of Alberta. The trial plans to enroll 10 participants.
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