Abstract
Purpose :
Discomfort and associated symptomatology is an important component of Dry Eye Disease (DED). While there are many scales available; the paper VAS (anchored 0-100) has been accepted by the FDA for the approval of symptom relief in three medications (lifitegrast, loteprednol etabonate 0.25% perfluorohexyloctane). The complex and arcane way this test is administered – pen, paper ruler and reviewer are prone to reporting errors. Here we aim to use an electronic version of the VAS to eliminate human errors. Towards improving data aquation the electronic VAS has been modified and adapted for mobile devices.
Methods :
Eighteen patients completed both VAS scales. Subjects with DED and previous experience were selected. Patients were randomly assigned to complete the Paper VAS or the Electronic VAS first in a 1:1 distribution. All subject completed both questionnaires following a predetermined sequence with time in-between repeating to account for subject fatigue. Electronic VAS was completed on the Ora Eyecup™ with 100mm electronic line, scores automatically uploaded to an online database. Paper VAS was marked on a 100mm line, measured, and then recorded; new document was used per questionnaire completion. The difference between the paired observations was evaluated using a paired t-test, and further evaluated by the sequence.
Results :
The difference between the paper VAS and the electronic VAS overall was 0.6755. The standard deviation on this difference was 4.2687, with a 95% confidence interval on the difference of (-0.7688, 2.1198) and a p-value of 0.3489 . The difference between the paper VAS and the electronic VAS when the electronic VAS was recorded first was 0.7318. The standard deviation on this difference was 3.5823, with a 95% confidence interval on the difference of (-1.049, 2.5132) and a p-value of 0.3982. The difference between the paper VAS and the electronic VAS when paper VAS was recorded first was 0.6192. The standard deviation on this difference was 4.9675, with a 95% confidence interval on the difference of (-1.8511, 3.0895) and a p-value of 0.6037.
Conclusions :
The electronic VAS was easy to use, mimicked the paper VAS appearance and was found reliable. The ease of recording, analysis, storage and retrieval of an electronic VAS is evident. The uses of electrical VAS in clinical trials should be considered.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.