A Novel Thermomechanical Treatment Compared To Thermal Pulsation In Treatment Of Meibomian Gland Dysfunction: A Randomized Control Trial
Published 2025 - 43rd Congress of the ESCRS
Reference: FP11.07 | Type: Free paper | DOI: 10.82333/w8vz-fv81
Authors: Metehan Simsek 1 , Sibel Ahmet* 1 , Nilay Kandemir Besek 1 , Ahmet Kirgiz 1
1Beyoglu Eye Training and Research Hospital,Istanbul,Türkiye
Purpose
The purpose of the study was to determine efficacy and safety of Tixel® (non-ablative thermomechanical skin treatment) for meibomian gland dysfunction (MGD) and compare to LipiFlow. (The Tixel medical device was 510K cleared by FDA for treatment of dry eye due to MGD in November 2024).
Setting
Private clinics and hospital departments
Methods
A prospective, randomized, single-masked, controlled, multicenter study (NCT05162261) to evaluate the response of signs and symptoms of MGD in 109 subjects randomized (1:1) to treatment with either Tixel (54) or LipiFlow (55). Tixel treatment included 3 sessions, and LipiFlow 1 session. Key eligibility criteria were OSDI score between 23 and 79, MGS ≤12, and TBUT ≤10. TBUT, MGS, corneal and conjunctival staining (CCS), and OSDI were assessed at Day 1 (baseline), Week 4, Week 12, and for 21 subjects from the Tixel group as part of an extension study, at 6 months. Adverse events (AEs) were recorded for safety. Non-inferiority of TBUT change from baseline in the Tixel group was compared to LipiFlow (LF) at Week 4 and Week 12.
Results
Significant improvements in mean TBUT (p<0.001) by 3.0±3.2 and 3.1±4.3 seconds after Tixel and 2.7±2.7 and 3.3±3.6 seconds after LipiFlow at 4 weeks and 12 weeks, respectively. At 6 months (n=21), the mean TBUT improvement for Tixel was 5.2±3.8 seconds (p<0.001). OSDI decreased (p<0.001) by 26.4±21.1 and 28.6±22.4 after Tixel, and 18.8±21.0 and 21.9±18.5 after LipiFlow at 4 and 12 weeks. At 6 months, OSDI improvement for Tixel was -24.3±26.5 (p=0.0004).
MGS increased (p<0.001) in both groups, with Tixel achieving improvements of 18.2±10.9 at 6 months (p<0.0001). CCS decreased (p<0.001) in both groups including at 6 months.
No study device-related adverse event (p>0.05) in visual acuity,IOP, keratometry, or lid margin assessments was noted.
Conclusions
Tixel® safely and successfully treats signs and symptoms of DED in patients with MGD. Non-inferiority compared to LipiFlow® was met. Improvements in TBUT, OSDI, MGS, and CCS were sustained through 6 months, offering a durable, quick (2-minute), radiation-free treatment option.