Abstract

Purpose:

Meibomian gland dysfunction disrupts tear film homeostasis and results in dry eye syndrome. The objective of this study is to determine whether transcutaneous radiofrequency (RF)-assisted meibomian gland expression, using the Envision platform and Forma-I handpiece is an effective treatment for dry eye syndrome.

Methods:

A multicenter prospective cohort study of patients with dry eye undergoing RF-assisted meibomian gland expression was completed from October 2019 to June 2022. The study was designed with multiple primary endpoints. These were defined as the change in Standard Patient Evaluation of Eye Dryness (SPEED) score, changes in Ocular Surface Disease Index (OSDI), Tear Breakup Time (TBUT), Corneal Fluorescence Score (CFS), and Meibomian Gland Score (MGS) at 1, 3, and 6 months after treatment. Secondary endpoints were measurements of patients' subjective improvement and subjective satisfaction with the treatment.

Results:

A total number of 47 patients were enrolled in the study at three separate institutions by three ophthalmologists (oculoplastics, refractive, and general). However, not all subjects had complete data on all observations at all time points following treatment. When a data point was missing, the entire patient’s outcome for that data set was excluded from the analysis. There was a significant improvement in SPEED score from baseline, 15.7 vs 11.4 at 1 month, 9.1 at 3 months, and 9.6 at 6 months (p<0.05). There was also a statistically significant improvement noted for OSDI at all time points measured, 34.5 at baseline vs 25.2 at 1 month, 21.2 at 3 months, and 23.6 at 6 months (p<0.5). CFS was significantly reduced in each eye at all time points following treatment as well, with 80% of eyes responding. TBUT similarly improved after treatment in each eye with an average of 6.3s at 1 month, 7.1s at 3 months, and 7.1s after treatment at 6 months vs 2.8s at baseline. The MGS also showed marked improvement across all time points, 5.6 at baseline vs 19.9 at 1 month, 24.7 at 3 months, and 22.9 at 6 months. Patients noted subjective improvement, with a lack of pain and discomfort from the treatment.

Conclusion:

This pilot study demonstrates that RF treatment with the Forma-I handpiece along with meibomian gland expression is an effective means to reduce the signs and symptoms of dry eye disease. The data support the conclusion that the treatment is safe and effective, lasting at least 6 months in most patients.

Keywords: Meibomian gland dysfunction, Radio frequency, Forma-I, TBUT, MGS, Ophthalmologists.
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