Abstract
PURPOSE: To assess the diagnostic performance of the InflammaDry test in diagnosing dry eye disease (DED) using different diagnostic criteria and across varying severities. METHODS: A retrospective study was conducted on 1,515 patients. Subjects were categorized into three groups: Group (1) DED based on Dry Eye Workshop-II (DEWS-II): Ocular Surface Disease Index (OSDI) ≥ 13 and at least one abnormal clinical sign (non-invasive tear break-up time [NIBUT] < 10 s, osmolarity > 308 mOsm/L, or corneal/conjunctival staining). Group (2) DED based on criteria used in prior clinical trials: OSDI > 13, Schirmer < 10 mm in 5 min, NIBUT < 10 s, and keratoconjunctival staining. Group (3) Healthy controls: OSDI ≤ 7, NIBUT ≥ 10 s, Schirmer ≥ 10 mm, and no keratoconjunctival staining. DED severity was classified using the ODISSEY European Consensus Group's definitions into severe and non-severe. Sensitivity, specificity, and predictive values were calculated for both criteria. RESULTS: 1,363 patients were included in Group 1, 401 in Group 2, and 152 in Group 3. Sensitivity was 81.30% in the population diagnosed using previous clinical trial criteria but decreased to 69.99% when applying the DEWS-II criteria. Specificity was 38.16% in both groups, with 409/467 false negatives respectively. CONCLUSION: InflammaDry shows good sensitivity in detecting DED in highly symptomatic cases with multiple clinical signs, but its performance decreases when broader criteria like DEWS-II are used. While valuable for detecting inflammation, routine use for DED diagnosis may lead to false negatives, especially in milder cases.