Association of Dry Eye Tests With Extraocular Signs Among 3514 Participants in the Sjögren's Syndrome International Registry

Purpose To identify a screening strategy for dry eye patients with a high likelihood of having Sjogren syndrome (SS) through the evaluation of the association of ocular surface tests with the extraocular signs used for the diagnosis of SS. Design Multicenter cross-sectional study. Methods The Sjogren's International Clinical Collaborative Alliance (SICCA) registry enrolled 3514 participants with SS or possible SS from 9 international academic sites. Ocular surface evaluation included Schirmer I testing, tear breakup time (TBUT), and staining of the cornea (0–6 points) and conjunctiva (0–6 points). Multivariate logistic regression analysis was performed to identify predictive factors for (1) histopathologic changes on labial salivary gland (LSG) biopsies (positive = focus score of ≥1 focus/4 mm²) and (2) positive anti-SSA/B serology. Results The adjusted odds of having a positive LSG biopsy were significantly higher among those with an abnormal Schirmer I test (adjusted OR = 1.26, 95% CI 1.05–1.51, P = .014) and positive conjunctival staining (for each additional unit of staining 1.46; 95% CI 1.39–1.53, P < .001) or corneal staining (for each additional unit of staining 1.14; 95% CI 1.08–1.21, P < .001). The odds of having a positive serology were significantly higher among those with an abnormal Schirmer I test (adjusted OR = 1.3; 95% CI 1.09–1.54, P = .004) and conjunctival staining (adjusted OR = 1.51; 95% CI 1.43–1.58, P < .001). Conclusions In addition to corneal staining, which was associated with a higher likelihood of having a positive LSG biopsy, conjunctival staining and abnormal Schirmer I testing are of critical importance to include when screening dry eye patients for possible SS, as they were associated with a higher likelihood of having a positive LSG biopsy and serology.