Randomized, double-masked, sham-controlled trial of efficacy and safety of quantum molecular resonance for treating meibomian gland dysfunction

Abstract

Background: This randomized, double-blind, sham-controlled trial aimed to evaluate the novel quantum molecular resonance (QMR) device for meibomian gland dysfunction (MGD) treatment.

Methods: Eighty participants diagnosed with MGD were randomized into QMR or sham-QMR groups. Each procedure was performed on days 0, 7, 14, and 21. Primary (meibum quality score) and other secondary outcomes were examined at baseline and weeks 7 and 11. Tear osmolarity and interleukin (IL)-6 and IL-1 receptor agonist levels were evaluated at baseline and week 7. Adverse events were recorded. A multilevel mixed-effect linear regression model was used for data analysis.

Results: Meibum quality (p = 0.008), corneal/conjunctival fluorescein staining score (p = 0.036), telangiectatic vessel area (p = 0.008), and superior (p = 0.011) and inferior (p = 0.020) lid meiboscale were significantly improved in the QMR group than those in the sham-treated group at week 11. Superior lid meiboscale (p = 0.027) and meibomian gland plugging grade (MGPG) (p = 0.017) were significantly improved in the QMR group at week 7. In the QMR group, Ocular Surface Disease Index (OSDI) scores and lid margin thickening grades were significantly lesser at weeks 7 (p = 0.002 and <0.001, respectively) and 11 (both p < 0.001) than the baseline values. At week 7, IL-6 levels were significantly decreased only in the QMR group (p = 0.016). All other parameters did not significantly differ. No serious adverse event occurred.

Conclusions: The QMR device was effective for MGD treatment, with improvements in meibum quality, corneal/conjunctival staining, telangiectatic vessels, MGPG, superior and inferior lid meiboscale, and decreased OSDI score, lid margin thickening grade, and tear IL-6 level.

Fig. 1. Eight outcomes in the QRM and sham-QRM groups at baseline and 7- and 11-week follow-ups.

A Meibum quality score, B Ocular Surface Disease Index score, C tear meniscus height, D noninvasive tear break-up time, E bulbar conjunctival hyperemia, F tear film lipid layer thickness, G tear osmolarity, and H sodium fluorescein staining score. + p < 0.05, comparison between the two study groups; * p < 0.05, comparison with baseline within each study group. QMR quantum molecular resonance.

Fig. 2. Eight outcomes in the QRM and sham-QRM groups at baseline and 7- and 11-week follow-ups.

A Schirmer’s test, B area of telangiectasia vessels, C lid margin thickening grade, D lid margin irregularity grade, E meibomian gland plugging grade, F superior lid meiboscale, G inferior lid meiboscale, and H meibum expressibility grade. + p < 0.05, comparison between the two study groups; * p < 0.05, comparison with baseline within each study group. QMR quantum molecular resonance.

Fig. 3. Logarithmic mean values of tear cytokine levels in the QRM and sham-QRM groups at baseline and 7-week follow-up.

Levels of (A) interleukin-6 and (B) interleukin-1 receptor antagonist in tear fluid. * p < 0.05, comparison with baseline within each study group. QMR quantum molecular resonance.