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Maxwell Pistilli, Maureen G. Maguire, Jack V Greiner, Penny A Asbell; The Association between Signs and Symptoms in Patients with Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2018;59(9):924. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To determine the degree of correlation between signs and symptoms of dry eye disease (DED) when assessed using standard procedures in a multicenter clinical trial.
Patients in the Dry Eye Assessment and Management (DREAM©) Study had 2 visits approximately 2 weeks apart to establish eligibility. Eligible eyes had at least two of the same following signs at both visits: conjunctival lissamine green staining score ≥1, corneal fluorescein staining score ≥4, tear break up time (TBUT) ≤7 seconds, and Schirmer test with anesthesia ≥1 to ≤7 mm/5min. Eligible patients scored between 21 and 80 out of 100 on the Ocular Surface Disease Index (OSDI); OSDI subscales (vision-related function, ocular symptoms, and environmental triggers) were also calculated. The average from both visits of the signs and symptoms was used for analysis. Spearman correlation coefficients were used due to the non-normality of the signs, and confidence intervals and p-values were calculated using a cluster-sampled bootstrap calculation to account for the correlation between the eyes of the same patient.
1,022 eyes from 535 DED patients at 27 clinical centers across the United States were eligible for inclusion. The correlations between OSDI and conjunctival staining (rho=-0.00, 95% confidence interval -0.08 to 0.08, p=0.98), corneal staining (0.05, -0.03 to 0.13, p=0.23), Schirmer test (-0.07, -0.16 to 0.01, p=0.08), and TBUT (-0.06, -0.14 to 0.02, p=0.11) were all small and not statistically significant (figure 1). The OSDI ocular symptoms subscale score was weakly correlated (magnitude of rho <0.15) with corneal staining, TBUT, and Schirmer test (table 1).
While some correlations were significant, estimates of the correlation were all less than 0.15 (95% confidence limits less than 0.22). Low correlation between signs and symptoms of DED has been extensively reported previously, but our results were obtained in a rigorous clinical trial setting with a large and diverse sample of DED patients. However, eligibility restrictions on the range of both signs and symptoms may have attenuated the associations relative to the entire patient population.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
Scatterplots of four signs vs OSDI (symptoms)
Correlation coefficients between signs and symptoms (OSDI and subscales)
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