Abstract
Purpose :
Clinicians lack standardized, objective, and scalable tools to assess several ocular surface clinical signs. We report the performance of a system for standardized quantification of corneal epitheliopathy, the most trusted sign of epithelial viability. The system comprises an imaging module and validated software to quantify corneal fluorescein staining (CFS) in patients with ocular surface diseases.
Methods :
We evaluated a cohort of patients with dry eye disease (DED) refractory to topical treatment who underwent bilateral lacrimal punctal occlusion and followed them for 12 weeks (NCT05748951). Follow-up visits were scheduled at 2, 6, and 12 weeks. Briefly, following a standard fluorescein staining protocol, epithelial staining was evaluated under the slit lamp with the NEI scheme at each visit. Immediately after the clinical CFS grading, we scanned the eye with the automated device to obtain an objective measurement of the area affected by fluorescein-positive epitheliopathy, a procedure that takes 30 seconds. We performed both evaluations in the right eye first, followed by the left.
Results :
Twenty-two patients (44 eyes) were enrolled and completed a 12-week follow-up. By the end of the study, the therapeutic intervention reduced the mean CFS, assessed by the clinician (NEI), from 8.3 at baseline to 4.3 at week 2, to 3.2 at week 6, and 2.9 at week 12, showing a 65% reduction compared with baseline values (p<0.001). The automated, standardized mean CFS scores decreased from 55.2 at baseline to 23.5 at week 2, 23.9 at week 6, and 22.7 at week 12, a 59% reduction compared with baseline values (p<0.001). There was a strong association between the overall clinical NEI and automated CFS scores (R=0.8; p<0.001).
Conclusions :
This study demonstrated that automated, objective corneal fluorescein staining quantification is comparable to clinical judgment (NEI scores) for the assessment and follow-up of epithelial disease. Automated, objective CFS scores have the advantage of providing more repeatable, unbiased data on the epithelial status, with the potential to become a trustable biomarker. Such a biomarker could help to establish standard cutoff values for a more rigorous approach to dry eye disease and other conditions affecting the corneal epithelium.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.