PURPOSE: The safety and efficacy of transepithelial photoreactive keratectomy (t-PRK) with or without end treatment laser polishing was compared with standard PRK in a prospective, randomized, controlled, single-blind, single-surgeon, single-center, post-market clinical study (NCT04698174).

METHODS: Thirty-five patients undergoing refractive surgery for correction of ametropia were bilaterally treated with conventional PRK in one eye and t-PRK in the other (16 with end-laser polishing and 19 without). Myopic and hyperopic patients were required to have a manifest refraction spherical equivalent (MRSE) of ≤−1.5D and ≥+1.5D, respectively. The primary endpoint was non-inferiority on absolute refractive predictability at 3 months post procedure, with a margin of 0.2D. Secondary endpoints included adverse events (AEs), MRSE, intraocular pressure (IOP), and monocular uncorrected and corrected distance visual acuity (UDVA/CDVA) at 6 months.

RESULTS: Mean baseline MRSE was −4.41D (PRK group) and −4.29D (t-PRK group). Mean ± standard deviation absolute refractive predictability at 3 months was 0.26±0.23 in the PRK group and 0.34±0.32 in the t-PRK group. This was below the 0.2D non-inferiority margin and not significantly different (p=0.2253). At 6 months, there were no significant differences in MRSE, IOP, UDVA, and CDVA between groups or between t-PRK with or without end-treatment laser polishing, with values demonstrating improved visual acuity in all groups. Two AEs (uveitis [t-PRK group] and COVID-19 infection [PRK group]) were reported; both were deemed unrelated to the procedure.

CONCLUSIONS: Non-inferiority on absolute refractive predictability was demonstrated between PRK and t-PRK, with no significant differences between groups. Both techniques predictably and effectively improved visual acuity in patients with ametropia, with no procedural-related AEs, up to a mean follow-up of 6 months.