Examining the effects of Blephasteam® ‐ clinical safety study results

Abstract

Abstract Purpose Heat therapy is the standard treatment regime for obstructive meibomian gland dysfunction (MGD). Research has shown the melting point of the meibum is raised to 35C in MGD compared to 32C in normal subjects, and sustained heat delivery is essential in effective treatments. This study was designed to evaluate the changes in ocular surface signs and temperature efficacy of a novel device which delivers latent moist heat to the eye lids and surrounding area for 10 minutes. Methods A prospective, controlled, single intervention trial recruited 25 normal subjects (M8, F17; age 29.2±5.7yrs). Ocular temperature, tear film stability, ocular hyperaemia and surface staining were measured, using non‐invasive ocular thermography and Efron grading respectively,, before and after device application. Results were checked for normality and compared using paired t‐testing. Results Temperature significantly increased to effective levels in both the upper (37.7±0.58C; p<0.0001) and lower (37.7±0.57C; p<0.0001) eyelids after treatment. Bulbar conjunctival hyperaemia significantly decreased after treatment (p<0.005), but limbal and palpebral hyperaemia were not significantly affected (p=0.33 and p=0.11 respectively). No significant change in corneal or conjunctival staining was observed (p=0.74 and p=0.97, respectively). Non‐invasive tear break‐up time (NIBUT) was not significantly changed in this normal cohort(p=0.12). Conclusion The Blephasteam® device provides safe and effective warmth to the ocular area without any adverse effects on the ocular surface in this study. Interestingly, even normal subjects had significantly less ocular redness after treatment. Commercial interest