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Randomised masked clinical trial of the MGDRx eyebag for the treatment of meibomian gland dysfunction-related evaporative dry eye
  1. Paramdeep Singh Bilkhu,
  2. Shehzad Anjam Naroo,
  3. James Stuart Wolffsohn
  1. Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, West Midlands, UK
  1. Correspondence to Professor James S Wolffsohn, School of Life and Health Sciences, Aston University, Birmingham B4 7ET, UK; j.s.w.wolffsohn{at}aston.ac.uk

Abstract

Background/aims To investigate the efficacy and safety of the MGDRx EyeBag (The Eyebag Company, Halifax, UK) eyelid warming device.

Methods Twenty-five patients with confirmed meibomian gland dysfunction (MGD)-related evaporative dry eye were enrolled into a randomised, single masked, contralateral clinical trial. Test eyes received a heated device; control eyes a non-heated device for 5 min twice a day for 2 weeks. Efficacy (ocular symptomology, non-invasive break-up time, lipid layer thickness, osmolarity, meibomian gland dropout and function) and safety (visual acuity, corneal topography, conjunctival hyperaemia and staining) measurements were taken at baseline and follow-up. Subsequent patient device usage and ocular comfort was ascertained at 6 months.

Results Differences between test and control eyes at baseline were not statistically significant for all measurements (p>0.05). After 2 weeks, statistically significant improvements occurred in all efficacy measurements in test eyes (p<0.05). Visual acuity and corneal topography were unaffected (p>0.05). All patients maintained higher ocular comfort after 6 months (p<0.05), although the benefit was greater in those who continued usage 1–8 times a month (p<0.001).

Conclusions The MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye. Subjective benefit lasts at least 6 months, aided by occasional retreatment.

Trial registration number NCT01870180.

  • Treatment other
  • Tears
  • Ocular surface

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