The effect of non-ablative thermomechanical skin treatment (Tixel®) on dry eye disease: A prospective two centre open-label trial

Abstract

Purpose: To determine the effects of a thermo-mechanical action-based peri-orbital fractional skin treatment (Tixel®) on dry eye disease.

Methods: This prospective, controlled, open labelled study was conducted at two study centres: Midland Eye, Solihull, UK, and Vallmedic Vision, Andorra. Participants were screened at the baseline visit (visit-1), received three Tixel® treatments at 2-weeks intervals including further assessment (visits 2, 3 and 4). Participants were followed up for three months post-treatment (visit 5). Vision, intraocular pressure (IOP), dry eye symptomatology were assessed, including the Ocular Surface Disease Index (OSDI) questionnaire, non-invasive tear break-up time (NIBUT) and tear osmolarity as well as detailed ophthalmic assessments.

Results: Seventy-four participants (41 in Birmingham and 33 in Andorra) with periorbital wrinkles and moderate to severe dry eye disease (DED) were enrolled. The mean age was 59.3 ± 13.3 years and 57 were females. No adverse events, no change in vision (p = 0.310) or IOP (p = 0.419) were observed. Tixel treatment was associated with clinically and statistically significant improvement in the DED symptoms, which was supported by a reduction of 21.40 ± 15.08 (P < 0.001) of the OSDI index. Non-invasive tear break-up time improved by 2.10 ± 0.91 s (p < 0.001) in the Birmingham cohort and 6.60 ± 2.13 s (p < 0.001) in the Andorra cohort. Tear osmolarity reduced from 299.8 ± 13.3 mOsm/L to 298.8 ± 15.6 mOsm/L following the Tixel treatment (p = 0.271).

Conclusions: Thermo-mechanical action-based peri-orbital fractional skin treatment Tixel® could be an attractive, safe and effective treatment for DED. This treatment is associated with high clinical and statistically significant improvement in DED signs and symptoms with no adverse events.

Keywords: Dry eye disease; Ocular surface; Tear film; Tear osmolarity; Tixel®.