title: Tear lipid layer thickness and ocular comfort with a novel device in dry eye patients with and without Sjögren's syndrome.
abstract: BACKGROUND
  To measure changes in tear-film lipid-layer thickness (LLT) and symptoms in patients with dry eye symptoms with and without Sjögren's syndrome after using a novel device. The device is designed to promote release of meibomian sebum into the tear film by delivering latent heat to the eyelids.
  
  
  METHODS
  Two prospective, controlled, randomised, observer-masked, single-intervention studies.
  
  
  METHODS
  Two independent studies were conducted in a major university hospital in the South West of England. The first study involved 24 patients with dry eye symptoms without Sjögren's [the PDE study] and the second study involved 31 patients with dry eye symptoms and Sjögren's syndrome (the SS study). The PDE study was randomised into two groups. Group I (12 patients) underwent 10 min of treatment with the activated device and Group II (12 patients) had no treatment. The SS study was similarly randomised into Group I (17 patients) and Group II (14 patients). The LLT and subjective alterations in ocular comfort of each subject were assessed prior and immediately after 5 and 30 min subsequent to the 10-min period. In the SS study, a further assessment was carried out at 60 min.
  
  
  RESULTS
  In the PDE study, treated patients exhibited a bilateral increase of LLT at 5 min (right eyes, 1.2 levels, p<0.0005; left eyes, 1.0 levels, p<0.0005, Mann-Whitney) and at 30 min (right eyes, 0.7 levels, p<0.005; left eyes, 0.6 levels, p<0.005). Mean symptom scores improved in the treated group compared with the control group at 5 min (treatment group, +2.0; control group, +0.2; p<0.05) and 30 min (treatment group, +2.8; control group, +0.4; p<0.015). In the SS study, treated patients exhibited a bilateral increase of LLT, 5 min (right eyes, 0.5 levels, p<0.009; left eyes, 0.5 levels, p<0.005, Monte Carlo 2-tailed), 30 min (right eyes, 0.5 levels, p<0.007; left eyes 0.5 levels, p<0.002) and 60 min (right eyes, 0.3 levels, p<0.1; left eyes, 0.3 levels, p<0.05). There was no change in any of the control patients in any of the assessments. With regard to symptom scores, the mean change at 5 min measured +0.8 in the treatment group and remained relatively unchanged at +0.1 in the control group (p<0.1). At 30 min, this change measured +1.3 in the treatment group and +0.1 in the control group (p<0.03) and at 60 min, the change measured +1.5 in the treatment group and remained at +0.1 in the control group (p<0.02).
  
  
  CONCLUSIONS
  Meibomian therapy with this novel device increases LLT and ocular comfort in patients with dry eye symptoms with and without Sjögren's syndrome.
authors.affiliation: Department of Ophthalmology, Royal Eye Infirmary, Plymouth, United Kingdom. antspit@yahoo.com
authors.forename: A
authors.initials: A
authors.lastname: Spiteri
authors.forename: M
authors.initials: M
authors.lastname: Mitra
authors.forename: G
authors.initials: G
authors.lastname: Menon
authors.forename: A
authors.initials: A
authors.lastname: Casini
authors.forename: D
authors.initials: D
authors.lastname: Adams
authors.forename: C
authors.initials: C
authors.lastname: Ricketts
authors.forename: P
authors.initials: P
authors.lastname: Hickling
authors.forename: E T
authors.initials: ET
authors.lastname: Fuller
authors.forename: J R
authors.initials: JR
authors.lastname: Fuller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015352:Dry Eye Syndromes / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation*; D050356:Lipid Metabolism; D008297:Male; D008537:Meibomian Glands / Q000378:metabolism*; D008875:Middle Aged; D009010:Monte Carlo Method; D015999:Multivariate Analysis; D011446:Prospective Studies; D012629:Sebum / Q000737:chemistry; D016037:Single-Blind Method; D012859:Sjogren's Syndrome / Q000150:complications / Q000628:therapy; D018709:Statistics, Nonparametric; D013666:Tears / Q000737:chemistry*; D008055:Lipids
chemical_list: D008055:Lipids