PURPOSE: To evaluate the safety and effectiveness of laser-assisted in situ keratomileusis (LASIK) performed with Teneo 317 Model 2 using the latest laser ablation algorithm (Proscan 1.28 SW) for the correction of high myopia (-6.0 D or higher).

METHODS: This prospective, multicenter, open-label, non-randomized, single-arm study included 158 eyes that underwent LASIK with the Teneo 317 Model 2 (version 1.28 US SW, Bausch & Lomb) for the correction of high myopia (-6.0 D or higher). Inclusion criteria were eyes with preoperative best-corrected distance visual acuity (CDVA) of 20/25 or better, manifest refraction spherical equivalent (MRSE) between -6.0 D and -11.50 D with or without astigmatism (cylinder between 0.0 D and -3.0 D). Outcome measures were uncorrected and corrected distance visual acuity (UDVA, CDVA), MRSE and astigmatic outcomes, 9 months postoperatively.

RESULTS: At postoperative 9 months, 94.8% of eyes achieved UDVA of 20/25 or better, and 100% achieved 20/40 or better. While 67.1% of the eyes showed no change in the lines of CDVA, 32.2% of the eyes gained 1 or more lines of CDVA. Mean MRSE improved from -7.96 ± 1.22 D preoperatively to -0.07 ± 0.39 D postoperatively with 87.7% and 98.1% of eyes achieving residual refractive error within ±0.50 D and ±1.00 D, respectively. The percentage of eyes with a residual refractive cylinder of ≤0.50 D and ≤1.00 D were 90.3% and 99.4%, respectively. Refractive outcomes were stable from postoperative 3 to 9 months.

CONCLUSION: LASIK performed with the Teneo 317 Model 2 excimer laser is safe and effective for correcting high myopia (with or without astigmatism), resulting in good visual and refractive outcomes that were stable through the last follow-up at 9 months.