Proof of Concept Evaluation of a Novel Eyelid-Warming Device in Meibomian Gland Dysfunction

Abstract

Abstract Purpose to evaluate a novel eyelid warming and neuro-stimulating device, Hydro-Eye, that delivers heat via low-level infrared radiation on the eyelids of patients with meibomian gland dysfunction (MGD). Methods Prospective interventional study. Patients with MGD were recruited at a single medical center. Main outcome measures included changes in tear break-up time (TBUT), Schirmer’s test, and Ocular Surface Disease Index (OSDI), overall satisfaction, as well as corneal signs of dry eye. Patients were instructed to use the device twice daily for 5 minutes on each eye, for a total of 14 days. Follow-up assessments were performed after the two-week treatment. Results A total of 10 patients were included, mean age was 67 ± 16 years, including six males (60%). Changes in pre- vs. post-treatment TBUT (5.0 to 6.11), OSDI (28.1 to 23.9), and Schirmer score (8.67 to 7.11) were not statistically significant. Over a course of 243 treatments, 131 (54%) demonstrated improvement in symptoms, 40% no change, and 6% worsening of symptoms. General satisfaction was observed overall in 80% of the patients. No adverse events were observed. Conclusion In this first study of a novel eyelid warming device, overall subjective satisfaction was reported in 80% of the patients, with no adverse events. Potential advantages of this user-friendly device include its ability to improve MGD and improving tear film stability, as well as symptomatic relief, while allowing the user to continue with normal daily functioning while undergoing treatment.