Validation of a Simple-to-Use, Affordable, Portable Wavefront Aberrometry-Based Auto Refractometer in a Paediatric Population.

Purpose: InstaRef R20 is a handheld, affordable auto refractometer based on Shack Hartmann aberrometry technology. The study's objective was to compare InstaRef R20's performance for identifying refractive error in a paediatric population to that of standard subjective and objective refraction under both pre- and post-cycloplegic conditions. Methods: Refraction was performed using 1) standard clinical procedure consisting of retinoscopy followed by subjective refraction (SR) under pre- and post-cycloplegic conditions and 2) InstaRef R20. Agreement between both methods was evaluated using Bland-Altman analysis. The repeatability of the device based on three measurements in a subgroup of 20 children was assessed. Results: The refractive error was measured in 132 children (mean age 12.31 ± 3 years). The spherical equivalent (M) and cylindrical components (J0 and J45) of the device had clinically acceptable differences (within ±0.50D) and acceptable agreement compared to standard pre- and post-cycloplegic manual retinoscopy and subjective refraction (SR). The device agreed within ± 0.50D of retinoscopy in 67% of eyes for M, 78% for J0 and 80% for J45 and within ± 0.50D of SR in 70% for M and 77% for cylindrical components. Conclusion: InstaRef R20 has an acceptable agreement compared to standard retinoscopy in paediatric population. The measurements from this device can be used as a starting point for subjective acceptance. The device being simple to use, portable, reliable and affordable has the potential for large-scale community-based refractive error detection.