Therapeutic Efficacy And Safety Of Non-Invasive Radiofrequency Treatment In Patients With Refractory Meibomian Gland Dysfunction: A Randomized Controlled Trial

Determine the clinical efficacy and safety of radiofrequency treatment (RF), followed by meibomian gland expression (MGX), in reducing the number and severity of symptoms and signs of dry eye disease secondary to refractory meibomian gland dysfunction

Single centre randomized sham-controlled trial 

This is a prospective, 24-week, double-masked, randomized, sham-controlled clinical trial comparing clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The study will also investigate the longitudinal changes in meibum quality and expressibility, as well as tear cytokines, after radiofrequency treatment and correlate them with changes in dry eye symptoms and tear film metrics. During the treatment period, all subjects will be given polyethylene glycol eye drops four times a day (Systane ULTRA, Alcon Company, Fort Worth, Texas, USA) to both eyes up until 6 months after treatment. 

A preliminary analysis of 26 subjects was conducted. Average age was 62.5 years. All subjects underwent RF followed by MGX. 80 shots were made with energy level between 2.5 - 3.5. Each eyelid was treated with 20 shots with 2 passes at 10 shots each. Compared to baseline, SPEED score (413.12 ± 5.472 vs 9.35 ± 4.804), NIKBUT (7.0356 ± 6.249 vs 10.4665 ±6.804), ocular redness score (1.468 ± 0.664 vs 1.240 ±0.578) and meibum expressibility score (2.8 ± 0.422 vs 1.75 ± 0.957) showed statistically significant improvements at 3 month after treatment. There were no significant differences in tear meniscus height and meibum quality score at 3 months compared to baseline. Patients experienced erythema after treatment, which resolved within seconds. 

Non-invasive radiofrequency treatment of the eyelid is a safe and potentially effective teatment for refractory MGD-related dry eye disease.