Treatment effect with 2 photorefractive intrastromal cross-linking protocols in low-grade myopia through 24-month...

To assess the effect of two high-oxygen epi-on PiXL treatments for low-grade myopia.

This prospective, randomized, intra-individually comparing, single-masked study included 23 healthy volunteers (46 eyes) aged 18-35 years with mild myopia, -0.75 to -2.50 D manifest refractive spherical equivalent (MRSE). One eye was randomized to a 4.0-mm homogenous treatment zone and the fellow eye to a 4.0-mm annular zone (16:40 min at 30 mW/cm² , fluence 15 J/cm² ). Uncorrected distance visual acuity (UDVA), MRSE, best spectacle-corrected visual acuity (BSCVA), Scheimpflug light scattering depths, mean keratometry (K_mean ) and endothelial cell count (ECC) were assessed through 24 months.

Similar improvements in UDVA were seen for the homogeneous and annular protocols at 1 month: -0.52 (-0.59, -0.39) and -0.49 (-0.59, -0.39) logMAR, respectively (medians and interquartile ranges, IQR), p = 0.91, and MRSE: +1.0 D (0.94, 1.31) and +1.0 D (0.69, 1.25), p = 0.17. Light scattering depths were 496 (465, 527) and 349 (247, 378) µm, respectively, and the reduction in mean keratometry was -0.8 D (-1.1, -0.7) and 0 D (-0.1, 0.1), p < 0.001. The treatment effect remained stable throughout 24 months. At 1 week, the participants reported less ocular discomfort with the annular protocol. No reductions were seen in BSCVA or ECC. No adverse events were reported.

PiXL can reduce low-grade myopia and improve uncorrected vision in healthy eyes. The initial ocular discomfort may be reduced with an annular treatment zone. Further studies are needed to optimize PiXL treatment parameters.