Abstract
BackgroundThe measurement of the pupillary function is an indispensable test in some eye examinations, being necessary the evaluation of the precision of instruments performing such measures. The aim of this study was to evaluate the intrasession repeatability of pupil size measurements provided by a multidiagnostic platform in a large sample of healthy eyes.MethodsThis prospective study enrolled 100 healthy eyes of 100 patients, with ages ranging from 23 to 65 years old. Repeated pupil size measures under photopic (P, 220 lx), mesopic (M, 160 lx), low mesopic (L, 70 lx), and scotopic conditions (S, 1 lx) were obtained with the VX120 system (Visionix-Luneau Technologies, Chartres, France) after a complete eye exam. Likewise, pupil size was also measured once in the fellow eye in a total of 75 eyes. The level of intrasession variability as well as differences between fellow eyes were evaluated.ResultsMost of differences between repeated measures did not exceed 0.5 mm (82% of S and 100% of P below this value). No significant differences between these repeated measures were found for S (p = 0.099) and L (p = 0.751). However, statistically significant differences were found between repeated measures for M (p = 0.002) and P (p = 0.003). The analysis of clinical relevance of differences between pairs (Passing-Bablok) only confirmed the clinical relevance of differences between the first and second repeated measurement of M. Concerning the comparative analysis between fellow eyes, no statistically significant differences in pupil size were found between right and left eyes in any light condition evaluated (p ≥ 0.227).ConclusionsThe VX120 system can provide consistent measurements of pupil size under scotopic, low mesopic and photopic conditions, with a relative limitation under mesopic conditions.
Highlights
The measurement of the pupillary function is an indispensable test in some eye examinations, being necessary the evaluation of the precision of instruments performing such measures
Repeated pupil size measures were obtained with the VX120 system in one eye from each subject that was selected randomly according to a random number sequence with the aim of avoiding the potential interference of the correlation that often exists between the two eyes of the same person
There was a mean decrease in S pupil diameter in the second measurement (0.2 mm) and an increase in the third, while the fluctuation between repeated measurements under L, M and P levels was below 0.1 mm
Summary
The measurement of the pupillary function is an indispensable test in some eye examinations, being necessary the evaluation of the precision of instruments performing such measures. The scientific literature on validation of pupillometers is scarce and with some limitations Among these limitations, the most relevant are the use of small samples of subjects used for the validations, the great variability among studies in the light conditions used during the measurements, and the performance of comparative studies between devices, but not considering an intrasession repeatability analysis [2,3,4,5,6,7,8,9,10]. The aim of the current study was to evaluate the intrasession repeatability of pupil size measurements provided by this multidiagnostic platform in a large sample of healthy eyes
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