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
Year: 2024
Type: article
Study design: 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: .
Source: Journal of Refractive Surgery
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Allergan
OpenAlex ID: W4401461300