Abstract
In this prospective study, 10 patients received three Tixel treatments and were followed for 20 weeks. Significant improvements were observed in symptoms (OSDI 45.1→21.7, p<0.001), SPEED score, and tear stability (NIBUT 4.7→8.0 seconds, p<0.05), with no adverse events. Tear lipid levels showed variable changes without statistical significance. Conclusion: Tixel provides a safe and effective improvement in evaporative dry eye symptoms and tear stability, with potential effects on tear film composition.
Purpose
To evaluate the effect of a thermo-mechanical action device on symptoms, signs and overall tear lipid profile in patients with evaporative dry eye.
Methods
A prospective, controlled, open-label research was conducted, involving participants with an Ocular Surface Disease Index (OSDI) score > 23 and a Non-Invasive Tear Break-Up Time (NIBUT) of less than 10 s. Participants attended 5 research visits. Participants underwent three sessions of Tixel® therapy on both eyes only at visits 1, 2, and 3. The initial 4 visits were spaced by a span of 2 weeks ± 5 days. The 5th appointment occurred 20 weeks after the 1st visit. During each visit, clinical measures including the OSDI score, the standard patient evaluation of ocular dryness questionnaire (SPEED) score, and NIBUT were documented. Tear samples, from the left eye only, were obtained during each visit and analysed using high-performance lipid chromatography to evaluate the lipid concentrations present.
Results
The study comprised 7 females and 3 males, with a mean age of 42 ± 9 years. No adverse occurrences were documented. A significant difference was noted in the mean OSDI score (45.11 ± 18.70 vs 21.72 ± 21.25, P < 0.001), the SPEED score (14.70 ± 1.70 vs 8.80 ± 6.12, P < 0.05), and the NIBUT (4.73 ± 2.37 vs 8.01 ± 2.32, P < 0.05) between visit 1 and visit 5. Despite individual variability in tear lipid content and the influence of sample volume, some participants showed an increase in total lipid levels following therapy.
Conclusions
The study demonstrated a significant improvement in the signs and symptoms of dry eye disease following Tixel® treatment, with no adverse events observed during the investigation. The findings indicate that Tixel® treatment is a promising therapeutic option for evaporative dry eye disease, warranting further investigation into its effects on tear lipids.
