Study of Tixel Device Treatment for Eye Wrinkles and Dry Eye Disease Symptoms

What this Trial Is About

Researchers are evaluating how a standard Tixel treatment compares to a sham treatment for reducing eye wrinkles and improving symptoms and signs of Dry Eye Disease DED. This prospective study aims to assess the safety and effects of these treatments on patients with mild to moderate peri-orbital wrinkles and DED symptoms. Participants will be randomly assigned to receive either three Tixel treatments or three sham treatments, each spaced two weeks apart. The Tixel treatment involves thermo-mechanical action targeting the skin around the eyes to potentially improve wrinkle appearance and dry eye symptoms. The study includes a single-blind design where participants do not know which treatment they receive. During the study, participants will be monitored for adverse events to evaluate safety, and researchers will assess changes in dry eye symptoms and signs over an average of four months. Participants must attend all study visits and follow instructions, with assessments including symptom questionnaires and clinical measurements of eye surface stability. The total participation duration includes these treatment and follow-up periods.

Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease