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Barbara Caffery, Carolyn G Begley, J Daniel Nelson; Corneal Staining Grades Change Over Time. Invest. Ophthalmol. Vis. Sci. 2020;61(7):326.
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Corneal fluorescein staining grades are often assessed at a fixed time point in dry eye disease (DED) clinical trials, or immediately in clinical practice. In this study, we investigate temporal changes in corneal fluorescein staining to gain a better understanding of the time-dependence of this important clinical outcome measure.
Fluorescein dye (5µl of 2%) was instilled into both eyes of 97 DED subjects at 5 clinical sites in North America. Photographs of corneal staining were taken in each eye every 30 seconds for approximately 5 minutes. Photographs were graded on a scale from 0 (no staining) to 5 (severe staining) by two experienced clinicians.
Corneal staining was significantly higher in subjects with Sjögren Syndrome (SS DED) compared to other (non-SS DED) subjects (t-test, p<0.0001). The average time to maximum, fully visible staining for all DED subjects was 2.2 ± 1.5 minutes (mean standard ± error); 1.8 ± 1.1 minutes for non-SS DED subjects and 3.0 ± 1.5 minutes for SS DED subjects. Accurate assessments of corneal staining occurred in only 15% of non-SS DED and 3% of SS DED subjects at 30 seconds, but rose to 59% of non-SS DED and 42% of SS DED subjects by 2 minutes.
The appearance of corneal staining can change markedly over time, leading to large errors (incorrect grading and increased variability) in the assessment of ocular surface disease, especially if staining is graded immediately or at a fixed time point.
This is a 2020 ARVO Annual Meeting abstract.
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