The effect of thermo-mechanical device (Tixel) treatment on evaporative dry eye disease - A pilot prospective clinical trial.

PURPOSE

To examine the effects of treatment with a thermomechanical skin device to the eyelid area on the clinical signs and symptoms of patients who suffer from dry eye disease (DED) secondary to meibomian gland dysfunction (MGD).

METHODS

Forty patients aged 45 years or older with DED due to MGD were recruited. Both eyes (n = 80) of each patient received three treatments with the Tixel device (Novoxel®, Israel), with each treatment separated by a 2-week period. Treatment was applied across the upper and lower eyelids, with the same intensity, tip protrusion distance, and contact duration. Two additional follow-up visits were performed at 2-week intervals after treatment cessation. DED status was evaluated during each visit via SPEED II questionnaire, tear break-up time (TBUT), corneal staining score (CSS), MGD score, and frequency of lubricant use. Visual acuity (VA) was recorded during first and last visits.

RESULTS

Mean age was 64.3 ± 12.4 years and 72.5 % (n = 29) were female. 45 % (n = 18) had a history of blepharitis, 12.5 % (n = 5) had chalazia, and 17.5 % (n = 7) suffered from allergic conjunctivitis. Mean follow-up time was 2.1 ± 0.6 months. Comparing the first and last visits, all parameters showed significant improvement after Tixel treatment: mean SPEED II scores (16.5 ± 5.9 to 11.8 ± 6.7, p < 0.001), CSS (2.0 ± 1.3 to 0.5 ± 0.9, p < 0.001), TBUT (2.7 ± 0.8 s to 6.5 ± 2.2 s, p < 0.001), MGD score (2.7 ± 0.5 to 1.2 ± 0.4, p < 0.001), and rate of lubricant use (3.4 ± 2.4 per day to 1.9 ± 2.0, p < 0.001). VA also improved (0.10 ± 0.11 logMAR to 0.08 ± 0.10 logMAR, p < 0.05). No major side effects were observed.

CONCLUSIONS

In this pilot study Tixel treatment induced significant improvement of signs and symptoms among patients with DED due to MGD. Benefits persisted for at least one month. Further randomized controlled double-blinded studies are needed.