Abstract
Purpose: :
To assess the severity grade of symptomatology and clinical findings of ocular sicca in patients with Sjögren’s syndrome (SS) compared with patients without SS (non-SS) in a cohort of dry eye patients and determine the predictors of primary SS (pSS).
Methods: :
Patients (n=327) with clinically significant aqueous-deficient dry eye participating in a prospective, randomized clinical trial were assessed at 23 sites in the USA. Conjunctival staining using lissamine green, corneal staining using fluorescein, Schirmer’s test with and without anesthesia, and a general medical review to determine presence of any previously established collagen vascular diseases were performed systematically. Serological testing for antinuclear antibody test (ANA), rheumatoid factor (RTF), Sjögren-specific antibodies A and B was also performed.
Results: :
38 (11.6%) patients were identified to have SS. 21/38 (55.3%) had pSS and 17/38 (44.7%) had secondary SS associated with other collagen vascular diseases. Compared with non-SS patients, patients with SS had significantly worse symptom scores as measured by OSDI (p<0.001) and worse clinical findings including mean conjunctival lissamine green staining score (p<0.0001), corneal fluorescein staining score (p=0.0004), and Schirmer test with (p=0.0026) and without (p=0.0057) anesthesia. No significant difference was observed in tear break-up time (p=0.2103) between non-SS and SS patients. There was no correlation between the temporal conjunctival staining with lissamine green and a diagnosis of pSS. A higher percentage (80%) of SS patients had a severity of ≥2 in the inferior corneal zone than in other zones (<60% with severity ≥2). Logistic regression analysis demonstrated that pSS is 13.9 times more likely to occur in patients with a positive ANA (95% confidence interval [CI] 5.2, 36.8; p<0.0001) and 4.8 times more likely in patients with positive RTF (95% CI 1.9, 12.0; p=0.0009).
Conclusions: :
In this study, patients with SS appeared to have significantly worse symptomatology and clinical findings compared with non-SS patients. There was no correlation between conjunctival staining patterns and diagnosis of SS. Positive ANA was associated with a significantly higher likelihood of pSS and could help with the diagnosis.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00784719
Keywords: cornea: tears/tear film/dry eye • autoimmune disease