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.

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.].

Clinical and refractive outcomes after topography-guided refractive surgery planned using Phorcides surgery planning software.

PURPOSE: To evaluate prospectively the clinical outcomes of topography-guided laser in situ keratomileusis (LASIK) surgery performed with Contoura Vision using the Wavelight excimer laser and planned with the Phorcides Analytical Engine. SETTING: Four clinical practices in the U.S. DESIGN: Prospective single-arm interventional study. METHODS: 130 eyes of 65 patients with myopia or myopic astigmatism were enrolled in a prospective study of visual and refractive outcomes after treatment with Contoura Vision using the Wavelight EX500 excimer laser to achieve optimal distance vision. At 3 months postoperatively, uncorrected distance visual acuity (UDVA), manifest refraction, and corrected distance visual acuity (CDVA) were measured and compared with previously published studies. RESULTS: At 3 months postoperatively, 100%, 89%, and 28% of eyes achieved UDVA of 20/20, 20/15, and 20/12.5 or better, respectively. 92% of eyes had postoperative UDVA equal to or better than their preoperative CDVA. Postoperative CDVA was equal to, 1 line better, or 2 lines better than the preoperative CDVA in 53%, 40%, and 6% of eyes, respectively. Only 1 eye lost 1 line of CDVA, and no eyes lost more than 1 line of CDVA. A statistically significant decrease was noted in subjective visual complaints, including glare, halos, difficulty driving at night, reading difficulty, starbursts, fluctuation in vision, and light sensitivity. CONCLUSIONS: The Phorcides Analytical Engine can be used to optimize visual outcomes for the correction of myopia and myopic astigmatism.

Clinical outcomes after topography-guided LASIK: comparing results based on a new topography analysis algorithm with those based on manifest refraction.

PURPOSE: To compare short-term refractive and visual acuity outcomes after topography-guided laser in situ keratomileusis (LASIK) planned with a new topography analysis system to those based on the manifest refraction. SETTING: Four clinical sites in the United States. DESIGN: Double-arm, nonmasked, nonrandomized retrospective chart review. METHODS: This was a retrospective study of postoperative refraction and visual acuity at least 2 months after uneventful LASIK using the Contoura Vision algorithm on the WaveLight Topolyzer VARIO laser. One arm comprised eyes treated using the manifest refraction (manifest), while the other included eyes treated with an ablation profile determined by the Phorcides Analytic Engine (analytic). RESULTS: Clinical results from a matched group of 317 manifest eyes and 323 analytic eyes were available for analysis. Residual refractive results, both sphere and cylinder, were similar between groups. However, significantly more eyes had 20/16 or better (-0.1 logarithm of the minimum angle of resolution) uncorrected distance visual acuity (UDVA) (62.5% analytic, 41.3% manifest) and corrected distance visual acuity (CDVA) (77.1% analytic, 51.4% manifest) in the analytic group. All eyes but 1 had a CDVA of 20/20 or better postoperatively. The number of patients with a UDVA better than their preoperative CDVA was significantly higher in the analytic group (36.5%) relative to the manifest group (23.0%). No eye in either group lost more than 1 line of CDVA; significantly more eyes in the analytic group (42.7%) gained 1 or more lines of CDVA relative to the manifest group (30.3%). CONCLUSIONS: Using the Phorcides Analytic Engine for topography-guided surgery planning increased the likelihood of 20/16 UDVA and CDVA relative to using the manifest refraction.

Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods.

PURPOSE: To identify the laser programming strategy that will achieve optimal refractive outcomes of LASIK with a topography-guided laser for eyes with a disparity between cylinder measured by manifest refraction and cylinder measured by topography. SETTING: Six surgeons at 5 clinical sites in the USA. DESIGN: Retrospective data review. METHODS: Preoperative, treatment, and postoperative data on 52 eyes that underwent topography-guided LASIK with the WaveLight EX500 Contoura® Vision excimer laser ablation profile in which the vectors representing the preoperative refractive cylinder and the cylinder measured by the WaveLight® Topolyzer™ VARIO Diagnostic Device (Vario cylinder) differed by >/= 0.50D and/or >/= 10 degrees of orientation were analyzed retrospectively. Data were contributed by six surgeons using the laser at 5 different clinical sites. Vector analysis of postoperative cylindrical refractive error and the actual laser programming strategy was used to calculate the cylindrical correction that would, theoretically, have completely eliminated postoperative refractive cylinder. This was compared to expected results using the preoperative manifest cylinder, the topographic cylinder, and the Phorcides Analytic Engine (Phorcides LLC, North Oaks MN; Phorcides). For analysis, subjects were stratified on the basis of the vector difference between Manifest and Topo cylinder (High, >0.75 D; and Low, ≤0.75 D). RESULTS: The poorest calculated theoretical outcomes were obtained with the manifest refraction (centroid: -0.43, 0.22; mean calculated error vector: 0.56 ± 0.42 D; p=ns). Better outcomes were obtained with the topographically measured refraction (centroid: 0.37, 0.02; mean calculated error vector: 0.47 ± 0.33 D; p=ns). The best outcomes were obtained with Phorcides (centroid: -0.15, 0.06; mean calculated error vector: 0.39 ± 0.28 D; p=ns). The mean error vector magnitude in the Phorcides Low group was significantly lower than for the Manifest and Topo Low groups (0.26 D vs 0.48 D and 0.33 D; p<0.01). The mean error magnitude in the Phorcides High group was nearly 0.25 D lower than for the Manifest High group (0.48 D vs 0.70 D; p<0.01), but was the same as for the Topo High group (0.48 D vs 0.48 D). CONCLUSION: Our study suggests that using the topographically measured cylinder or the cylinder selected by Phorcides will produce more desirable refractive outcomes than entry of the preoperative refractive cylinder as the basis for correction of myopia and myopic astigmatism with the WaveLight Contoura Vision excimer laser.