Validation of a Modified National Eye Institute Grading Scale for Corneal Fluorescein Staining

被引:7
|
作者
Sall, Kenneth [1 ,3 ]
Foulks, Gary N. [2 ]
Pucker, Andrew [1 ]
Ice, Karen L. [1 ]
Zink, Richard C. [1 ]
Magrath, George [1 ]
机构
[1] Lexitas Pharm Serv Inc, Durham, NC USA
[2] Univ Louisville, Louisville, KY USA
[3] Lexitas Pharm Serv Inc, 313 Foster St, Durham, NC 27701 USA
来源
CLINICAL OPHTHALMOLOGY | 2023年 / 17卷
关键词
clinical trials; corneal sodium fluorescein staining; dry eye disease; repeatability; validation; LISSAMINE GREEN; ROSE-BENGAL;
D O I
10.2147/OPTH.S398843
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Purpose: Validation of the novel Lexitas modified NEI scale for use in assessment of corneal fluorescein staining.Patients and Methods: A series of 18 illustrations and 14 clinical photographs depicting varying severity levels of corneal fluorescein staining were assessed by 3 independent examiners. Regions of the cornea were graded for staining severity based on 3 different grading scales: the original NEI staining scale (density-based scoring; 0-3 scale), a structured version of the NEI scale (dot-count scoring; 0-3 scale), and the Lexitas modified NEI staining scale (0-4 scale with half-point increments). Kappa statistics (simple and weighted) were computed to determine intra-examiner image grading repeatability for each examiner over 2 separate assessments. Inter-examiner assessment reliability utilized the scores from the first read of each examiner, and pairs of examiners to compute kappa statistics. Results: Data was analyzed from the scores provided by the examiners from each gradable corneal region on 32 images (18 illustrations and 14 photographs) for a total of 154 corneal regions across the 3 grading scales for each validation run. The mean intra-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.67/0.72, 0.91/ 0.94, 0.80/0.92 for the graded illustrations, and 0.83/0.88, 0.76/0.85, 0.77/0.88 for the graded photographs, respectively. The mean inter-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.59/ 0.65, 0.86/0.90, and 0.78/0.91 for the graded illustrations, and 0.80/0.88, 0.84/0.89, 0.69/0.88 for the graded photographs, respectively.Conclusion: The expanded scale of the Lexitas modified NEI staining scale demonstrated a high degree of reliability and repeatability of grading assessments within and across individual examiners, comparing favorably with the original NEI staining scale. A future investigation into the in-office utility of the Lexitas modified NEI staining scale is warranted.
引用
收藏
页码:757 / 767
页数:11
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