title: Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01870180.
authors.affiliation: Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, West Midlands, UK.
authors.forename: Paramdeep Singh
authors.initials: PS
authors.lastname: Bilkhu
authors.affiliation: Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, West Midlands, UK.
authors.forename: Shehzad Anjam
authors.initials: SA
authors.lastname: Naroo
authors.affiliation: Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, West Midlands, UK.
authors.forename: James Stuart
authors.initials: JS
authors.lastname: Wolffsohn
mesh_terms: D000328:Adult; D019781:Corneal Topography; D015352:Dry Eye Syndromes / Q000150:complications / Q000628:therapy*; D005141:Eyelid Diseases / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects / Q000295:instrumentation*; D050356:Lipid Metabolism; D008297:Male; D008537:Meibomian Glands; D009994:Osmolar Concentration; D016037:Single-Blind Method; D013666:Tears / Q000737:chemistry / Q000378:metabolism; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
keywords: Ocular surface; Tears; Treatment other