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Satasuk Joy Bhosai, Bruce D. Gaynor, Ana Maria Heidenreich, Esen K. Akpek, Kazuko Kitagawa, Genevieve Larkin, Travis Porco, Thomas M. Lietman, SICCA study group; Evaluation of Dry Eye Diagnostic Tests of the Cornea and Conjunctiva for Predicting Sjogren’s Syndrome from the International Sjogrens Syndrome Registry. Invest. Ophthalmol. Vis. Sci. 2012;53(14):547.
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Currently, a wide variety of diagnostic tests are used in the evaluation of Sjogren’s syndrome (SS). Literature suggests that clinical signs and symptoms in isolation may be poorly predictive for SSA or SSB antibodies and salivary gland biopsy in SS. We examine ocular signs that may be useful to clinicians in determining whether further workup for SS is warranted by other specialties. Recent diagnostic criteria for SS utilize an ocular SICCA score that includes conjunctival and corneal staining, but not tear break-up time (TBUT) or Schirmer's testing. This study evaluates the role of ocular diagnostic tests (Schirmer’s 1, tear breakup time, conjunctival and corneal staining) and their association with SS outcomes for positive serology, defined as antibody positivity or RF and ANA titer ≥ 1:320, and positive salivary gland biopsy, defined as focal lymphocytic sialadenitis with focus score ≥1.
A total of 2510 cases were collected through September 2011 in the Sjögren’s International Collaborative Clinical Alliance (SICCA), which includes 9 international sites. Participants range from possible early SS to advanced disease. Ordinal scores were computed from ocular staining scores of the cornea (stained with fluorescein) and conjunctiva (stained with lissamine green), with corneal scores ranging from 0-6, and conjunctival scores from 0-3 temporally and nasally. Tear breakup time was censored at 11 sec. We conducted multivariate logistic regression, using a AIC-based cross-validated regression classifier for preliminary variable screening.
We found significant effects for conjunctival scores and tear breakup time in the final model, which was nonlinear in the predictors. The adjusted odds ratios for positive serology was 11.3 (95%CI, 8.61-15.20) comparing the most abnormal conjunctival score to normal, and 2.54 (1.77-3.73) comparing the most abnormal tear breakup time to normal patients. The adjusted odds ratio for positive salivary biopsy was 5.20 (3.29-11.8) comparing the most severe conjunctival score to normal, and 3.54 (1.74-7.66) comparing the most abnormal tear breakup time to normal (assuming normal tear breakup). Schirmer’s score and corneal scores were not significant variables in the adjusted model.
Schirmer’s test without anesthesia, conjunctival score, and corneal score in isolation are highly associated with SS. However, when evaluated in combination with other diagnostic tests, Schirmer’s score and corneal score add little to the predictive value of our model beyond the conjunctival score, confirming that they do not contribute further information necessary for a diagnosis of Sjorgrens syndrome.
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