Plastic lid spring for eyelid closure in patients with facial nerve palsy
Suture Eyelid Spring for Eyelid Closure in Patients With Facial Nerve Palsy
This study is testing a new eyelid spring to help people with facial nerve palsy keep their eyes closed better and more comfortably.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT06895902 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a polypropylene suture eyelid spring designed to assist patients with facial nerve palsy who cannot close their eyes, a condition known as paralytic lagophthalmos. The hypothesis is that the elastic properties of the coiled suture will help keep the eyelid closed while allowing for normal eyelid opening. Current treatments often involve inconvenient methods that can impair vision and social interaction, making this innovative approach potentially more effective and patient-friendly. The study will evaluate the force required for effective eyelid closure and the overall efficacy of the eyelid spring.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with facial nerve transection or paralytic lagophthalmos that has not improved after six weeks.
Not a fit: Patients who are unable to tolerate awake eyelid surgery under local anesthetic may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients by providing a more effective and comfortable solution for eyelid closure.
How similar studies have performed: While similar approaches have been explored, this specific use of a polypropylene suture eyelid spring is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta and 1 other locations
- Eye Institute of Alberta, Royal Alexandra Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- Eye Institute of Alberta, Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Edsel Ing, MD PhD FRCSC — University of Alberta
- Study coordinator: Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA
- Email: ed.ing@ualberta.ca
- Phone: 6472930155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.