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2007 OMIG, Abstract 1

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The SICCA Study: Preliminary Results from Ocular Examinations in 736 Patients
John Whitcher (Proctor/UCSF), Ana Heidenreich (UBA,GH), Zhang Shunhua (PUMCH), Sven Johansen (CUH,G), Kazuko Kitagawa (KMU), Erich Strauss (UCSF), Steve Pflugfelder, and Austin Mircheff (Consultants)
Purpose: To develop ocular diagnostic criteria for primary Sjögren’s Syndrome (pSS) that are validated by data, quantitative, and that are user friendly enough to be universally accepted.  
Methods: Five previously established Sjögrens Clinics were selected to participate: San Francisco (UCSF), Buenos Aires (UBA,GH) Beijing (PUMCH), Copenhagen (CUH,G), and Kanazawa (KMU). Clinicians in each center performed ocular exams, salivary-oral exams, and rheumatologic exams in a standardized fashion on all patients referred to the clinics with a preliminary diagnosis of pSS. Serologic samples were collected. A standardized, quantitative ocular scoring system (the SICCA score) was developed with the active in put of all the authors at an initial planning meeting in San Francisco. Fluorescein 0.5% was used to stain the cornea (quantitatively measuring punctate corneal staining, the presence of filaments, staining in the central cornea, and confluent staining) for a possible total score of 6. Lissamine green 1% was used to stain the nasal and temporal conjunctiva for a total possible score of 6, giving equal weight to the cornea and conjunctiva for a possible total score of 12 for each eye.
Results: A cohort of 736 patients with the tentative diagnosis of pSS was evaluated. There was a strong statistical correlation (p<.0001) between the SICCA score of >=4 vs. <4 and the labial salivary gland (LSG) focus scores >1, + serum anti-SS-A/-B, TBUT <10 sec, and Schirmer <=5mm. Dry eye symptoms were only slightly significant (p 0.02). With a SICCA score of >=3 vs. <3 the p-values (<.0001) remained the same except for the Schirmer <=5mm that was less significant (0.003) and for dry eye symptoms that were barely significant (0.035).   
Conclusion: The ocular SICCA score was found to be a sensitive and reliable method for grading the cornea and conjunctiva in patients with a proven diagnosis of pSS. This is the first ocular scoring system for patients with pSS that is wholly quantitative and that has been validated by data from a large cohort of patients who have undergone systematic evaluation. It appears that an ocular SICCA score of 3 has the highest correlation for the greatest number of patients when compared with the LSG biopsy focus scores and the anti-SS-A/-B serology. 

Disclosure code: N


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