A clinical evaluation of the BioPen

Abstract

We conducted a clinical trial on the Oculab BioPen, a portable, handheld applanation instrument designed to measure ocular axial lengths. We compared the measurements obtained from the BioPen with those obtained from the Ultrascan Digital B System IV from CooperVision. Accuracy and reproducibility were assessed in vitro by performing ten measurements with each instrument on a precalibrated 25.8-mm plastic test block. The in vivo reproducibility of the BioPen was evaluated by performing five serial readings on each eye of 58 patients. Keratometry measurements were also recorded to determine whether the BioPen provided consistent readings regardless of corneal curvature. We found the BioPen to be as accurate and reproducible as the Ultrascan Digital B in vitro and in vivo. Corneal curvature had no effect on the in vivo reproducibility of the BioPen.