Facial Nerve PalsyEarly Phase 1SESPLNCT06895902
Suture Lid Spring for Lid Closure in Patients With Facial Nerve Palsy
A Early Phase 1 study testing Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos in people with Facial Nerve Palsy and Corneal Exposure, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Nerve Palsy, Corneal Exposure, Paralytic Lagophthalmos
- What is being tested?
- Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Apr 2025to 31 Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older with facial nerve transection or paralytic lagophthalmos that has not improved after 6 weeks.
Who cannot join
- Patients unable to tolerate awake eyelid surgery under local anesthetic.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Eye Institute of Alberta, Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Edsel B Ing, MD PhD, 780) 735 8784, ed.ing@ualberta.ca
Erin MM&E Childs, 780) 735 8784, erin.childs@ahs.ca
- Recruiting
Eye Institute of Alberta, Royal Alexandra Hospital
Edmonton, Alberta, T5J 0N3
Edsel Ing, MD PhD FRCSC MPH MEd MIAD MBA, 16472930155, ed.ing@ualberta.ca
Rita Whitford, whitford@ualberta.ca
About this study
Official title: Suture Eyelid Spring for Eyelid Closure in Patients With Facial Nerve Palsy
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.
Read more
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.
Read the detailed description
PURPOSE: To develop and test a plastic lid spring to help patients with facial nerve palsy who cannot close their eyes (paralytic lagophthalmos) and protect their cornea.
HYPOTHESIS: Polypropylene monofilament suture (Prolene) is Health Canada-approved and commonly used in surgery including surgery in the eyelid region. When the prolene suture is coiled in a loop it has elastic spring that can assist in lid closure. If the prolene loop coil is sutured to the tarsus and underneath the orbital septum inferior to the superior orbital rim, it should help keep the eyelid closed, while still allowing the levator and Mullers muscles to open the lid.
JUSTIFICATION: Current methods to help patients with paralytic lagophthalmos require improvement. Tarsorraphy decreases peripheral vision and adversely affects cosmesis. Gold weights are static and require a forced blink and gravity to work. Gold weights may not help when the patient is supine. Wire lid springs require suturing or fixation to the lateral orbital bone and extensive dissection. The thin dental wire frequently extrudes through the skin.
In contrast to the above a plastic suture lid spring would be placed in the central lid with less dissection than a dental wire spring, and about the same amount of dissection as a gold weight. As the plastic has innate elasticity it provides dynamic lid closure whether the patient is upright or supine.
OBJECTIVES AND METHOD:
- FORCE DETERMINATION The amount of force required to close the lids is estimated by F=m*g, where m is in the range of 1.2 to 1.4 grams and g is 9.81 m/s^2. The investigators will measure the dynamic force of 10 mm compression on the prolene suture. Ten mm is the sum of normal vertical palpebral fissure height (margin reflex distance 1 and margin reflex distance 2.) Prolene suture loops of calibres from 5-0 to 2 will be tested in a mechanical engineering laboratory. Since humans may blink 12 times per minute of the waking day, repetitive strain tests will be performed to determine the longevity of the plastic spring.
- CADAVER STUDY The cadavers will be accessed through the University of Alberta anatomy lab, general surgery anatomy service and used in keeping with the intent of the donors and donor families. The investigators will not be collecting identifiers. A 2 mm deep incision will be made in the upper eyelid, 2 centimeters in length. The investigators will place the prolene suture in the cadaver lid underneath the septum superiorly and suture to the tarsus inferiorly. The cadaver study will allow optimal determination of the anatomic placement of the suture for human studies. The prolene loop can be custom-sized for the wound bed and tied to itself once the desired size is achieved.
- HUMAN STUDIES
Patients with lagophthalmos will have short to long-term placement of the prolene loop. Because of the local anesthetic, and bleeding and bruising, approximately 1 month will be required to determine if the prolene loop is beneficial, or whether it should be removed and a gold weight implanted instead. During this 1 month the patient with paralytic lagophthalmos is not at any increased risk of corneal exposure than during their pre-operative state and should maintain their corneal lubrication.
As there are only a limited number of patients with paralytic lagophthalmos, further testing can be performed on ptosis patients undergoing anterior levator Patients with anterior ptosis repair will have temporary placement of the lid spring, and blink dynamics will be observed. Note that patients requiring ptosis repair have the same anatomic dissection as required for the plastic spring. The placement of the prolene spring will in no way harm the result of the ptosis surgery. The prolene plastic spring will be placed for about 2 minutes to observe blink dynamics and removed and the ptosis surgery will proceed as usual.
In the patients with paralytic lagophthalmos. Pre-operative lagophthalmos in mm, House-Brackman score for facial nerve impairment, visual acuity, corneal status, corneal sensation, Bells phenomenon, lid contour and cosmesis, will be recorded. The same measurements will be repeated at the post-operative 1 week, 1-month, 2-month, 6-month, and 12-month checks.
PLAN FOR DATA ANALYSIS
Paired t-tests will be used to compare the pre-operative and 1-month post-operative results, and then to compare the 1 month with the 6-month results.
The investigators will monitor the patients over a 12-month period to see if the lid spring loses elasticity or has wound complications.
- Being tested
- Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos
- Keywords
- Paralytic lagophthalmos
- Medical subject headings
- Bell Palsy, Lagophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene Suture Eyelid Spring for Paralytic LagophthalmosDevice
The polypropylene loop eyelid suture spring will be centrally placed without fixation to the bone unlike a metal lid spring.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Amount of lid closure in millimetres
Measured: within the first 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start28 Apr 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve PalsyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-masked surgical intervention
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edsel Ing, MD PhD FRCSC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895902
- Sponsor's protocol ID
- Pro00149272
- Acronym
- SESPL
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Eyelid Spring for Eyelid Closure in Patients With Facial Nerve Palsy
- ClinicalTrials.gov ID
- NCT06895902
- Acronym / sponsor ID
- SESPL / Pro00149272
- Keywords
- Paralytic lagophthalmos
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PURPOSE: To develop and test a plastic lid spring to help patients with facial nerve palsy who cannot close their eyes (paralytic lagophthalmos) and protect their cornea.
HYPOTHESIS: Polypropylene monofilament suture (Prolene) is Health Canada-approved and commonly used in surgery including surgery in the eyelid region. When the prolene suture is coiled in a loop it has elastic spring that can assist in lid closure. If the prolene loop coil is sutured to the tarsus and underneath the orbital septum inferior to the superior orbital rim, it should help keep the eyelid closed, while still allowing the levator and Mullers muscles to open the lid.
JUSTIFICATION: Current methods to help patients with paralytic lagophthalmos require improvement. Tarsorraphy decreases peripheral vision and adversely affects cosmesis. Gold weights are static and require a forced blink and gravity to work. Gold weights may not help when the patient is supine. Wire lid springs require suturing or fixation to the lateral orbital bone and extensive dissection. The thin dental wire frequently extrudes through the skin.
In contrast to the above a plastic suture lid spring would be placed in the central lid with less dissection than a dental wire spring, and about the same amount of dissection as a gold weight. As the plastic has innate elasticity it provides dynamic lid closure whether the patient is upright or supine.
OBJECTIVES AND METHOD:
- FORCE DETERMINATION The amount of force required to close the lids is estimated by F=m*g, where m is in the range of 1.2 to 1.4 grams and g is 9.81 m/s^2. The investigators will measure the dynamic force of 10 mm compression on the prolene suture. Ten mm is the sum of normal vertical palpebral fissure height (margin reflex distance 1 and margin reflex distance 2.) Prolene suture loops of calibres from 5-0 to 2 will be tested in a mechanical engineering laboratory. Since humans may blink 12 times per minute of the waking day, repetitive strain tests will be performed to determine the longevity of the plastic spring.
- CADAVER STUDY The cadavers will be accessed through the University of Alberta anatomy lab, general surgery anatomy service and used in keeping with the intent of the donors and donor families. The investigators will not be collecting identifiers. A 2 mm deep incision will be made in the upper eyelid, 2 centimeters in length. The investigators will place the prolene suture in the cadaver lid underneath the septum superiorly and suture to the tarsus inferiorly. The cadaver study will allow optimal determination of the anatomic placement of the suture for human studies. The prolene loop can be custom-sized for the wound bed and tied to itself once the desired size is achieved.
- HUMAN STUDIES
Patients with lagophthalmos will have short to long-term placement of the prolene loop. Because of the local anesthetic, and bleeding and bruising, approximately 1 month will be required to determine if the prolene loop is beneficial, or whether it should be removed and a gold weight implanted instead. During this 1 month the patient with paralytic lagophthalmos is not at any increased risk of corneal exposure than during their pre-operative state and should maintain their corneal lubrication.
As there are only a limited number of patients with paralytic lagophthalmos, further testing can be performed on ptosis patients undergoing anterior levator Patients with anterior ptosis repair will have temporary placement of the lid spring, and blink dynamics will be observed. Note that patients requiring ptosis repair have the same anatomic dissection as required for the plastic spring. The placement of the prolene spring will in no way harm the result of the ptosis surgery. The prolene plastic spring will be placed for about 2 minutes to observe blink dynamics and removed and the ptosis surgery will proceed as usual.
In the patients with paralytic lagophthalmos. Pre-operative lagophthalmos in mm, House-Brackman score for facial nerve impairment, visual acuity, corneal status, corneal sensation, Bells phenomenon, lid contour and cosmesis, will be recorded. The same measurements will be repeated at the post-operative 1 week, 1-month, 2-month, 6-month, and 12-month checks.
PLAN FOR DATA ANALYSIS
Paired t-tests will be used to compare the pre-operative and 1-month post-operative results, and then to compare the 1 month with the 6-month results.
The investigators will monitor the patients over a 12-month period to see if the lid spring loses elasticity or has wound complications.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-masked surgical intervention
| Arm | Type | Receives |
|---|---|---|
| Placement of suture lid spring | Experimental | Device: Polypropylene Suture Eyelid Spring for Paralytic LagophthalmosInstead 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18 years of age or older with facial nerve transection or paralytic lagophthalmos that has not improved after 6 weeks.
Key exclusion criteria (1 listed)
- Patients unable to tolerate awake eyelid surgery under local anesthetic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypropylene Suture Eyelid Spring for Paralytic LagophthalmosThe polypropylene loop eyelid suture spring will be centrally placed without fixation to the bone unlike a metal lid spring. | Device | Placement of suture lid spring |
Primary outcome
Primary outcome
Time frame: within the first 2 weeks.
Amount of lid closure in millimetres
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edsel Ing, MD PhD FRCSC principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos in people with Facial Nerve Palsy and Corneal Exposure, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA (6472930155 ext. 780) 735-8784, ed.ing@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: within the first 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.