Am J Ophthalmol. 2026 Jul 26:S0002-9394(26)00413-7. doi: 10.1016/j.ajo.2026.07.034. Online ahead of print.
ABSTRACT
OBJECTIVE: To longitudinally compare changes in ocular surface signs and symptoms over two to three years in patients with isolated KCS (KCS-only) and those with concomitant SjD (KCS+SjD).
DESIGN: Prospective cohort study using data from the Sjögren’s International Collaborative Clinical Alliance (SICCA) registry. Participants were enrolled from 2003-2012 and invited for 2- to 3-year follow-up.
PARTICIPANTS: Participants with KCS (defined as ocular staining score [OSS] ≥ 5) who presented at both baseline and follow-up visits were included.
METHODS: Participants underwent standardized ocular surface testing, including OSS, Schirmer I, tear break-up time (TBUT), and Ocular Surface Disease Index-6 (OSDI-6), at baseline and follow-up visits. Multivariable linear regression models evaluated differences in longitudinal change in ocular metrics between KCS-only and KCS+SjD participants.
MAIN OUTCOME MEASURES: Changes in ocular metrics, including OSS, Schirmer I, TBUT, and OSDI-6, from baseline to follow-up.
RESULTS: This analysis included data from 427 participants (mean age: 54.4±12.8 years, 94.8% female), including 305 with KCS+SjD and 122 with KCS-only. Participants with KCS+SjD exhibited significantly more severe dry eye signs than those with KCS-only at both time points. After adjusting for covariates, the change score for OSS was 1.51 points higher (95% confidence interval [CI], 0.99-2.04; P <.001) in the KCS+SjD groups compared to the KCS-only group. Similarly, participants with KCS+SjD demonstrated greater longitudinal decline in TBUT (-1.10 sec, 95% CI: -1.56 to -0.65; P <.001) and in Schirmer I (-2.16 mm, 95% CI: -3.31 to -1.01; P <.001). The difference in OSDI-6 scores was not statistically significant (0.36, 95% CI, -0.60 to 1.33; P = .46).
CONCLUSIONS: Participants with KCS+SjD exhibited more severe baseline signs and greater longitudinal worsening of objective ocular findings compared to KCS-only participants. These findings support the hypothesis that KCS associated with SjD and isolated KCS may represent distinct clinical forms of dry eye disease and may help differentiate these dry eye subtypes.
PMID:42503399 | DOI:10.1016/j.ajo.2026.07.034
