Background <p>This randomized, double-blind, sham-controlled trial aimed to evaluate the novel quantum molecular resonance (QMR) device for meibomian gland dysfunction (MGD) treatment.</p> Methods <p>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.</p> Results <p>Meibum quality (<i>p</i> = 0.008), corneal/conjunctival fluorescein staining score (<i>p</i> = 0.036), telangiectatic vessel area (<i>p</i> = 0.008), and superior (<i>p</i> = 0.011) and inferior (<i>p</i> = 0.020) lid meiboscale were significantly improved in the QMR group than those in the sham-treated group at week 11. Superior lid meiboscale (<i>p</i> = 0.027) and meibomian gland plugging grade (MGPG) (<i>p</i> = 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 (<i>p</i> = 0.002 and &lt;0.001, respectively) and 11 (both <i>p</i> &lt; 0.001) than the baseline values. At week 7, IL-6 levels were significantly decreased only in the QMR group (<i>p</i> = 0.016). All other parameters did not significantly differ. No serious adverse event occurred.</p> Conclusions <p>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.</p>

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

  • Lita Uthaithammarat,
  • Ngamjit Kasetsuwan,
  • Usanee Reinprayoon,
  • Yuda Chongpison,
  • Wiyada Quanchareonsap,
  • Paphaphat Dissaneevate

摘要

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.