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).

SETTING: 10 US clinical sites.

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). Outcomes were assessed at postoperative 9 months and included uncorrected and corrected distance visual acuity (UDVA, CDVA), MRSE, and astigmatic outcomes. No nomogram adjustments were made, and the patient's manifest refraction was used for the laser treatment.

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

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