Effectiveness and Safety of Non-Invasive Radiofrequency Treatment for Adults with Persistent Meibomian Gland Dysfunction-Related Dry Eye

What this Trial Is About

Researchers are evaluating the effectiveness and safety of radiofrequency RF treatment combined with meibomian gland expression MGX compared to MGX alone in patients with refractory meibomian gland dysfunction MGD-related dry eye disease. This 24-week randomized, double-masked, sham-controlled clinical trial aims to determine if RF treatment improves tear breakup time, a key measure of eye surface stability, in patients who have not responded to conventional therapies over at least two years. Participants will be assigned to one of two groups one receiving the Thermage FLX System RF treatment followed by MGX, and the other receiving a sham treatment followed by MGX. The RF treatment involves applying controlled radiofrequency energy to the upper and lower eyelids and the tragus area to target meibomian glands, followed immediately by meibum expression using forceps with topical pain relief. The sham group undergoes a simulated treatment without radiofrequency energy, also followed by MGX. During the study, participants will have assessments including non-invasive keratographic tear breakup time NIKBUT, symptom questionnaires, visual acuity tests, and monitoring for eye-related and other adverse events. The main outcome measured is the change in tear breakup time from baseline to six months post-treatment. Safety and symptom scores will also be evaluated. Participants will be followed for six months, with all treatments and evaluations conducted under medical supervision.

Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD