Purpose: Our aim was to evaluate changes in dry eye diagnostic status following implementation of the new dry eye diagnostic criteria in Japan.
Design: This was a multicenter cross-sectional study.
Methods: We recruited 295 individuals (81 men, 214 women, average age 43.6 ± 14.3 years) seen for general ophthalmic checkup and dry eye examinations. Using results of the Schirmer I test, tear breakup time, and fluorescein and Rose Bengal staining, patients were diagnosed as having definite dry eye (DDE), probable dry eye (PDE), or as being normal according to both the old and new Japanese dry eye diagnostic criteria.
Results: Mean ages of normal participants and patients with PDE and DDE were 37.0 ± 10.4, 41.7 ± 14.4, and 47.7 ± 15.3 years, respectively (p < 0.001). All 37 individuals diagnosed as normal following the old criteria were also diagnosed as normal with the new diagnostic criteria. Among the 60 patients diagnosed as PDE with the old criteria, 19 (31.7%) were diagnosed as normal and 41 (68.3%) as PDE with the new diagnostic criteria. Of the 198 patients diagnosed with DDE following the old criteria, 59 (29.7%) were diagnosed as PDE and 139 (70.2%) as DDE with the new diagnostic criteria. There was no significant difference in dry eye severity index scores between the old and new diagnostic criteria.
Conclusion: A shift in the final dry eye diagnostic status from DDE to PDE and from PDE to normal was observed with the implementation of the new dry eye diagnostic criteria, suggesting that patients at the severe end of the dry eye disease spectrum are now diagnosed as DDE disease under the new criteria.