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עמוד בית
Tue, 16.04.24

ORIGINALS

IMAJ | volume 26

Journal 1, January 2024
pages: 45-48

First-in-human Clinical Trial of a Novel Eyelid warming Device in Meibomian Gland Dysfunction

1 Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel 2 Talpiot Medical Leadership Program, Sheba Medical Center, Tel Hashomer, Israel 3 Smart Lamp Ballast Ltd., Rishon Letzion, Israel 4 Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Summary

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.

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