Safety and Effectiveness of Laser in Situ Keratomileusis Using the Teneo 317 Model 2 for Correcting Myopia and Myopic Astigmatism: Results of the U.S. FDA Clinical Trial.

ABSTRACT

PURPOSE: To evaluate the safety and effectiveness of a new aspheric ablation profile for correcting myopia and myopic astigmatism. METHODS: This prospective, multicenter study included patients who underwent laser in situ keratomileusis (LASIK) using a new aspheric ablation profile of the Technolas Teneo 317 (Model 2) excimer laser (version 1.28 US SW) by Technolas Perfect Vision, Bausch+Lomb, Inc. No nomogram adjustments were made, and the patient's manifest refraction was entered into the laser (for treatment). Postoperative assessments included visual and refractive outcomes. Patients were asked to complete the Patient-Reported Outcomes With LASIK (PROWL) questionnaire preoperatively and postoperatively. RESULTS: A total of 333 eyes from 168 patients with a mean age of 33 ± 7 years were included. At postoperative 9 months, uncorrected and corrected distance visual acuities of 20/25 or better were seen in 97.8% and 100% of eyes, respectively. None of the eyes lost two or more lines of corrected distance visual acuity. The mean manifest spherical refraction improved from -5.67 ± 2.52 diopters (D) preoperatively to -0.04 ± 0.32 D postoperatively, with 92.7% of eyes achieving residual refractive error within ±0.50 D. Residual refractive cylinder within ±0.50 and ±1.00 D was seen in 93% and 99.4% eyes, respectively. The refractive outcomes were stable throughout the follow-up of 9 months. The proportion of patients satisfied with their vision rose from 27.7% preoperatively to 98.1% postoperatively. CONCLUSIONS: LASIK performed using a new aspheric ablation profile of the Technolas Teneo 317 (Model 2) excimer laser is safe and effective for correcting myopia and myopic astigmatism, yielding excellent visual and refractive outcomes that were stable over 9 months. [J Refract Surg. 2024;40(8)e544-e553.].