Wavefront-guided PRK treatment of myopia using a refractive aberrometer. Issue 3 (March 2023) - Hofmeister, Elizabeth M.
Abstract : A prospective multicentered wavefront-guided PRK clinical study using an aberrometer that incorporated a Hartmann-Shack wavefront sensor demonstrated good predictability and visual outcomes, and favorable patient-reported outcomes for the correction of myopia. Abstract : Purpose: To evaluate the safety, effectiveness, and patient-reported outcomes of wavefront-guided photorefractive keratectomy (PRK) for the correction of myopic refractive errors with and without astigmatism. Setting: U.S. multicenter study. Design: Prospective, nonrandomized clinical investigation. Methods: 334 eyes (167 patients) underwent wavefront-guided PRK with the STAR S4 IR Excimer Laser System. Patients had preoperative myopic refractive errors with sphere up to −8.00 diopters (D) and cylinder up to −4.00 D with a maximum spherical equivalent (SE) of −10.00 D. All eyes were targeted for emmetropia, and treatment plans were derived from the iDESIGN system wavefront measurements. Results: At 6 months, the point of refractive stability, 99.4% of eyes achieved 20/20 or better uncorrected distance visual acuity (UDVA), 92% of eyes achieved 20/16 or better UDVA, 85.5% of eyes achieved manifest refraction SE (MRSE) within 0.50 D of target, mean SE was −0.06, and less than 1% of eyes lost more than 2 lines of corrected distance visual acuity. Glare and halos occurred with similar or lower frequencies at 6 months vs preoperative. Results from the National Eye Institute Refractive Error Quality of life questionnaire showed statistically significant improvements at 6 months vs preoperative across most measures of vision-related functioning and well-being. Approximately 98% of patients reported high satisfaction with their overall vision at 6 months. Conclusions: Wavefront-guided PRK with the iDESIGN aberrometer was safe, effective, and predictable for the correction of low to moderate myopia with and without astigmatism and led to high patient satisfaction.