April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Diagnostic Performance of Osmolarity Combined With Subset Markers of Dry Eye Disease in an Unstratified Patient Population
Author Affiliations & Notes
  • B. D. Sullivan
    TearLab, Corp., San Diego, California
  • D. C. Eldridge
    TearLab, Corp., San Diego, California
  • M. Berg
    TearLab, Corp., San Diego, California
  • V. Kosheleff
    TearLab, Corp., San Diego, California
  • A. Porreco
    TearLab, Corp., San Diego, California
  • J. Truitt
    TearLab, Corp., San Diego, California
  • M. A. Lemp
    Ophthalmology, Georgetown and George Washington U, Washington, Dist. of Columbia
  • Footnotes
    Commercial Relationships  B.D. Sullivan, TearLab, Corp., E; 7,017,394, P; D.C. Eldridge, TearLab, Corp., C; M. Berg, TearLab, Corp., I; TearLab, Corp., E; V. Kosheleff, TearLab, Corp., E; A. Porreco, TearLab, Corp., E; J. Truitt, TearLab, Corp., E; M.A. Lemp, TearLab, Corp., I; TearLab, Corp., C.
  • Footnotes
    Support  Alcon Laboratories
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 3380. doi:
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      B. D. Sullivan, D. C. Eldridge, M. Berg, V. Kosheleff, A. Porreco, J. Truitt, M. A. Lemp; Diagnostic Performance of Osmolarity Combined With Subset Markers of Dry Eye Disease in an Unstratified Patient Population. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3380.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : The purpose of this study was to evaluate whether the diagnostic performance of a novel, global test for dry eye disease (TearLabTM osmolarity) was improved by the addition of markers specific for aqueous deficient or evaporative dry eye.

Methods: : Clinical signs were evaluated in both eyes of 299 subjects chosen from the general patient population (N = 82 Normal, N = 217 Dry Eye) across 11 sites in the EU and US. Diagnostic thresholds were defined as Osmolarity > 308 mOsms/L, TBUT <= 7 seconds, Schirmer < 7 mm, corneal staining > 0 and conjunctival staining > 0 in either eye. Sensitivity and specificity were calculated for each individual sign, as well as in combination with osmolarity through logical AND and logical OR functions.

Results: : Individually, signs were ranked as follows: osmolarity (81%/80%; sensitivity/specificity), corneal staining (70%/82%), TBUT (79%/70%), conjunctival staining (86%/52%), and Schirmers (40%/82%). When required to exhibit both and elevated osmolarity AND one additional sign, the signs increased specificity at the expense of sensitivity: conjunctival staining (71%/93%), TBUT (62%/100%), corneal staining (59%/99%), and Schirmers (31%/99%). Similarly, when required to exhibit either an elevated osmolarity OR one other sign, the signs increased sensitivity at the expense of specificity: corneal staining (92%/63%), Schirmers (90%/63%), TBUT (98%/50%), and conjunctival staining (96%/40%). The best overall performance, as measured by the sum of sensitivity and specificity were osmolarity AND conjunctival staining (163%), osmolarity AND TBUT (162%), and then osmolarity alone (161%).

Conclusions: : Although commonly used for diagnosis, markers that independently report the degree of lacrimal or meibomian dysfunction may misclassify hybrid forms of the disease. When combined with osmolarity, clinical signs of dry eye disease demonstrated improved overall diagnostic performance. However, the total sensitivity and specificity of combined testing was not substantially different than the diagnostic performance of osmolarity alone.

Keywords: cornea: tears/tear film/dry eye 

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