A Simplified Quantitative Method for Assessing Keratoconjunctivitis Sicca From the Sjögren's Syndrome International Registry

Whitcher, John P.; Shiboski, Caroline H.; Shiboski, Stephen C.; Heidenreich, Ana Maria; Kitagawa, Kazuko; Zhang, Shunhua; Hamann, Steffen; Larkin, Genevieve; McNamara, Nancy A.; Greenspan, John S.; Daniels, Troy E.; Sjögren's International Collaborative Clinical Alliance Research Groups,

doi:10.1016/j.ajo.2009.09.013

« Previous Next »American Journal of Ophthalmology
Volume 149, Issue 3 , Pages 405-415, March 2010

A Simplified Quantitative Method for Assessing Keratoconjunctivitis Sicca From the Sjögren's Syndrome International Registry

John P. Whitcher
- Department of Ophthalmology, University of California, San Francisco, San Francisco, California
Caroline H. Shiboski
- Department of Orofacial Sciences, University of California, San Francisco, San Francisco, California
Stephen C. Shiboski
- Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California
Ana Maria Heidenreich
- Department of Ophthalmology, German Hospital and University of Buenos Aires, Buenos Aires, Argentina
Kazuko Kitagawa
- Department of Ophthalmology, Kanazawa Medical University, Ishikawa, Japan
Shunhua Zhang
- Department of Ophthalmology, Peking Union Medical College Hospital, Beijing, China
Steffen Hamann
- Department of Ophthalmology, Copenhagen University Hospital, Glostrup, Denmark
Genevieve Larkin
- Department of Ophthalmology, King's College London, London, United Kingdom
Nancy A. McNamara
- Department of Ophthalmology, University of California, San Francisco, San Francisco, California
John S. Greenspan
- Department of Orofacial Sciences, University of California, San Francisco, San Francisco, California
Troy E. Daniels
- Department of Orofacial Sciences, University of California, San Francisco, San Francisco, California
- Inquiries to Troy E. Daniels, 513 Parnassus Avenue, Box 0422, University of California, San Francisco, San Francisco, CA 94143–0422
Sjögren's International Collaborative Clinical Alliance Research Groups

Accepted 18 September 2009. published online 25 December 2009.

Purpose

To describe, apply, and test a new ocular grading system for assessing keratoconjunctivitis sicca (KCS) using lissamine green and fluorescein.

Design

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 (≥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.