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Published on: April 1, 2019
First-in-human Clinical Trial of a Novel Eyelid warming Device in Meibomian Gland Dysfunction
Mattan Arazi1, Michael Lemanski2, Michael Belkin1
1Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Background:
Meibomian gland dysfunction (MGD) causes significant patient morbidity as well as economic burden.
Objectives:
To evaluate a novel eyelid warming and a neuro-stimulating device that delivers heat via low-level infrared radiation to the eyelids of patients with MGD.
Methods:
In this prospective interventional study, patients with MGD were recruited at a single medical center. The main outcome measures included changes in tear break-up time (TBUT), Schirmer's test, and Ocular Surface Disease Index (OSDI), overall satisfaction, and 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 2-week treatment.
Results:
A total of 10 patients were included; mean age was 67 ± 16 years; six males (60%). Changes in pre- vs. post-treatment TBUT (5.0-6.11), OSDI (28.1-23.9), and Schirmer score (8.67-7.11) were not statistically significant. Over a course of 243 treatments, 131 (54%) demonstrated improvement in symptoms, 40% found no change, and 6% experienced worsening of symptoms. General satisfaction was observed overall in 80% of the patients. No adverse events were observed.
Conclusions:
In this first study of a novel eyelid warming device, overall subjective satisfaction was reported in 80% of patients. Potential advantages of this user-friendly device include its ability to improve MGD and tear film stability, as well as symptomatic relief, while allowing the user to continue with normal daily functioning while undergoing treatment.
