title: Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial.
abstract: OBJECTIVE
  To compare the effectiveness of a single LipiFlow(®) treatment with combined lid warming and massage in patients with meibomian gland dysfunction (MGD).
  
  
  METHODS
  In this prospective, randomized, crossover, observer-masked clinical trial, subjects were randomized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation (LTP) system treatment or to perform combined twice-daily lid warming and massage for 3 months. All subjects were examined before, and 1 and 3 months after initiation of treatments. Investigated parameters included subjective symptoms, lipid layer thickness, meibomian gland assessment, tear break-up time, tear osmolarity, corneal and conjunctival staining, Schirmer test values, and tear meniscus height.
  
  
  RESULTS
  A total of 31 subjects completed the 3-month follow-up. At 1 and 3 months, patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index (OSDI) scores compared with those in the lid-margin hygiene group. Both treatments produced a significant improvement in expressible meibomian glands compared to the baseline parameters, but no significant difference was noted between the two groups. The other investigated objective parameters did not show a significant difference.
  
  
  CONCLUSIONS
  Results of our study show that a single LipiFlow treatment is as least as effective as a 3-month, twice-daily lid margin hygiene regimen for MGD. However, the present study was observer-masked only, and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups.
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. Electronic address: David.Finis@med.uni-duesseldorf.de.
authors.forename: David
authors.initials: D
authors.lastname: Finis
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Hayajneh
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: König
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Borrelli
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schrader
authors.affiliation: Department of Ophthalmology, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Geerling
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D015352:Dry Eye Syndromes / Q000503:physiopathology / Q000628:therapy*; D005141:Eyelid Diseases / Q000503:physiopathology / Q000628:therapy*; D005143:Eyelids / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D008297:Male; D008405:Massage / Q000379:methods*; D008537:Meibomian Glands / Q000503:physiopathology*; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome; D055815:Young Adult
keywords: LipiFlow(®); dry eye; meibomian gland dysfunction (MGD)