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A. Spiteri, M. Mitra, G. J. Menon, A. Casini, D. Adams, C. Ricketts, P. Hickling, E. T. Fuller, J. R. Fuller; Tear Lipid Layer Thickness and Ocular Comfort With a Novel Device in Dry Eye Patients With and Without Sjogren`s Syndrome. Invest. Ophthalmol. Vis. Sci. 2007;48(13):437.
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To measure changes in tear-film lipid layer thickness (LLT) and symptoms in dry eye patients with and without Sjogren`s syndrome after using a novel device. The device was designed to promote release of meibomian sebum into the tear film by delivering latent heat to the eyelids.
Two independent studies were carried out over a 3 year period in a major University Hospital in the South West of England. The first study involved 24 Primary Dry Eye subjects (the PDE study) and the second study involved 31 dry eye patients with Sjogren`s Syndrome (the SS study). The PDE study was randomised into two groups. Group I (12 patients) underwent ten minutes 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).
In the PDE study treated patients exhibited bilateral increase of LLT at 5 minutes (Right eyes 1.2 levels, p<0.0005 and Left eyes 1.0 levels, p<0.0005, Mann-Whitney) and at 30 minutes (Right eyes 0.7 levels, p<0.005 and Left eyes 0.6 levels, p<0.005). Mean symptom scores improved in the treated group compared with the control group at 5 minutes (treatment group +2.0, control group +0.2, p<0.05) and 30 minutes (treatment group +2.8, control group +0.4, p<0.015). In the SS study treated patients exhibited bilateral increase of LLT, 5 minutes (Right eyes 0.5 levels, p<0.009 and Left eyes 0.5 levels, p<0.005, Monte Carlo 2-tailed), 30 minutes (Right eyes 0.5 levels, p<0.007 and Left eyes 0.5 levels, p<0.002) and 60 minutes (Right eyes 0.3 levels, p<0.1 and Left eyes 0.3 levels, p<0.05). There was no change in any of the control patients in any of the assessments.Mean symptom scores improved in the treated group compared with the control group at 2 minutes (treatment group +3.9, control group +3.1, p<0.1), 30 minutes (treatment group +4.4, control group +3.1, p<0.03) and 60 minutes (treatment group +4.6, control group +3.1, p<0.02).
Meibomian therapy with this novel device increases LLT in individuals with both Primary Dry Eye disease and dry eyes associated with Sjogren`s Syndrome. This implies a more stable tear film which leads to subjective improvement in ocular comfort.
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