Suture Lid Spring for Facial Nerve Palsy

(SESPL 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.

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

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.

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.

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.¹³⁴⁶⁷