A simplified quantitative method for assessing keratoconjunctivitis sicca from the Sjögren's Syndrome International Registry.
OBJECTIVE
To describe, apply, and test a new ocular grading system for assessing keratoconjunctivitis sicca (KCS) using lissamine green and fluorescein.


METHODS
Prospective, observational, multicenter cohort study.


METHODS
The National Institutes of Health-funded Sjögren's Syndrome International Registry (called Sjögren's International Collaborative Clinical Alliance [SICCA]) is developing standardized classification criteria for Sjögren syndrome (SS) and is creating a biospecimen bank for future research. Eight SICCA ophthalmologists developed a new quantitative ocular grading system (SICCA ocular staining score [OSS]), and we analyzed OSS distribution among the SICCA cohort and its association with other phenotypic characteristics of SS. The SICCA cohort includes participants ranging from possibly early SS to advanced disease. Procedures include sequenced unanesthetized Schirmer test, tear break-up time, ocular surface staining, and external eye examination at the slit lamp. Using statistical analyses and proportional Venn diagrams, we examined interrelationships between abnormal OSS (>or=3) and other characteristics of SS (labial salivary gland [LSG] biopsy with focal lymphocytic sialadenitis and focus score >1 positive anti-SS A antibodies, anti-SS B antibodies, or both).


RESULTS
Among 1208 participants, we found strong associations between abnormal OSS, positive serologic results, and positive LSG focus scores (P < .0001). Analysis of the overlapping relationships of these 3 measures defined a large group of participants who had KCS without other components of SS, representing a clinical entity distinct from the KCS associated with SS.


CONCLUSIONS
This new method for assessing KCS will become the means for diagnosing the ocular component of SS in future classification criteria. We find 2 forms of KCS whose causes may differ.
Whitcher
John P
JP
Department of Ophthalmology, University of California, San Francisco, San Francisco, California 94143-0422, USA.
Shiboski
Caroline H
CH
Shiboski
Stephen C
SC
Heidenreich
Ana Maria
AM
Kitagawa
Kazuko
K
Zhang
Shunhua
S
Hamann
Steffen
S
Larkin
Genevieve
G
McNamara
Nancy A
NA
Greenspan
John S
JS
Daniels
Troy E
TE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D004396:Coloring Agents; D005260:Female; D019793:Fluorescein; D005456:Fluorescent Dyes; D006801:Humans; D038801:International Classification of Diseases; D007638:Keratoconjunctivitis Sicca / Q000145:classification / Q000175:diagnosis*; D008086:Lissamine Green Dyes; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D012859:Sjogren's Syndrome / Q000145:classification / Q000175:diagnosis*; D055815:Young Adult
D004396:Coloring Agents; D005456:Fluorescent Dyes; D008086:Lissamine Green Dyes; D019793:Fluorescein