Suture Lid Spring for Facial Nerve Palsy

(SESPL Trial)

Overseen By Erin Childs, MOA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alberta

Disqualifiers: Unable to tolerate local anesthetic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eyelid spring made from surgical stitches (polypropylene suture eyelid spring) to assist individuals with facial nerve palsy, such as Bell's palsy or nerve damage from accidents, who cannot fully blink. The goal is to enhance eyelid closure to protect the eye and prevent vision problems, avoiding the drawbacks of current treatments like constant eye drops or eyelid weights. The new suture spring is designed to be less invasive and reduce complications such as infection. The trial seeks participants who have experienced facial nerve problems for more than six weeks and continue to struggle with blinking. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative solution.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this suture lid spring is safe for eyelid closure?

Research has shown that eyelid springs, such as the new Polypropylene Suture Eyelid Spring, have helped about 83% of patients with facial nerve issues. These springs assist in closing the eyelid, which is crucial for eye protection. The new suture spring uses materials commonly found in eyelid surgeries, so doctors are familiar with it.

This suture spring is thinner and smoother than other options, like metal springs or gold weights, potentially reducing the risk of it poking through the skin. However, like any material placed in the body, it could still become infected or require replacement over time. As this is an early trial, extensive data may not yet be available. However, the materials used are already common in medical procedures, suggesting they are generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Polypropylene Suture Eyelid Spring for facial nerve palsy because it offers a new approach to aiding eyelid closure. Unlike traditional surgical options, such as gold weight implants or tarsorrhaphy, which either add weight or partially sew the eyelids together, this method uses a suture loop placed under the eyelid skin. This innovative technique aims to provide a less invasive and potentially more comfortable solution for patients, enhancing eyelid movement without the need for additional weight or permanent changes to the eyelid structure. By exploring this new technique, researchers hope to provide a more natural and efficient way to help patients with facial nerve palsy regain eyelid function.

What evidence suggests that the suture lid spring is effective for facial nerve palsy?

Research has shown that polypropylene stitches can effectively improve eyelid function. One study found that a similar method using these stitches succeeded in 90% of patients for enhancing eyelid structure and in 87% for improving eyelid movement. Most patients experienced better eyelid movement and appearance after treatment. In this trial, participants will receive the experimental suture lid spring, which might be a better option because it is less likely to cause issues like skin extrusion, where the material pushes through the skin, compared to metal options. The stitches are thin and have no sharp edges, potentially making them safer for long-term use. ^{1 3 4 6 7}

Who Is on the Research Team?

Edsel Ing, MD PhD FRCSC

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for patients with permanent facial nerve palsy, such as Bell's Palsy, who can't blink properly. This affects their eye health and vision. Suitable candidates are those looking for an alternative to constant eye lubrication, patching, or surgeries that have cosmetic and functional downsides.

Inclusion Criteria

I am an adult with unimproved facial nerve or eyelid paralysis after 6 weeks.

Exclusion Criteria

I cannot undergo eyelid surgery with just local anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Force Determination

Determine the amount of force required to close the lids using prolene suture loops

Not specified

Cadaver Study

Determine optimal anatomic placement of the suture for human studies using cadavers

Not specified

Human Studies

Short to long-term placement of the prolene loop in patients with lagophthalmos to assess benefits

1 month

Post-operative checks at 1 week, 1 month, 2 months, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Polypropylene Suture Eyelid Spring

Trial Overview The study tests a new eyelid spring made from polypropylene sutures designed to help close the eyelids of people with paralytic lagophthalmos. It aims to be less invasive than current treatments like gold weights or metal springs and doesn't attach to bone.

How Is the Trial Designed?

Group I: Placement of suture lid spring Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06895902

Suture Lid Spring for Lid Closure in Patients With Facial ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12251122/

Upper Eyelid Static Surgical Approaches for the Treatment of ... Conclusions: Gold or platinum weight implantation provides the most reliable improvement for severe upper eyelid dysfunction in facial palsy.

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/482233

Prospective Evaluation of Eyelid Function With Gold ... Overall there was an extremely low complication rate, the procedure was effective, and the level of patient satisfaction was high despite some lingering ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681508011224

The orbicularis oculi muscle flap: Its use for treatment of ... Satisfactory results can be obtained in complete facial nerve palsy. Nevertheless, the authors believe that better results are obtained when frontal branch ...

5. researchgate.net researchgate.net/publication/235378624_Lower_eyelid_suspension_using_polypropylene_suture_for_the_correction_of_punctal_ectropion

Lower eyelid suspension using polypropylene suture for ... RESULTS: At 1 year follow up anatomical success was achieved in 28 (90%) patients and functional success noted in 27 (87%) patients. Recurrence ...

6. withpower.com withpower.com/trial/early-phase-1-paralysis-2-2025-15ad2

Suture Lid Spring for Facial Nerve Palsy (SESPL Trial) Research shows that eyelid springs, similar to the Polypropylene Suture Eyelid Spring, have been effective in helping 83% of patients with facial nerve ...

7. journals.lww.com journals.lww.com/sjop/fulltext/2025/04000/ophthalmic_and_periocular_management_of_facial.2.aspx

Ophthalmic and periocular management of facial nerve palsy Facial nerve palsy (FNP) can be a highly distressing condition with sight-threatening sequelae. However, major advances in ophthalmic and oculoplastic ...