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Comparison of U.S. FDA Premarket Approval Studies Between Ray Tracing-Guided LASIK with InnovEyes Sightmap Versus
Mina M Sitto1, Majid Moshirfar2,3,4, Triston B Crook5
1Hoopes Vision Research Center, Hoopes Vision, 11820 S. State St. #200, Draper, UT, 84020, USA.
Introduction:
To compare the U.S. Food and Drug Administration (FDA) premarket approval (PMA) trials of topography-guided laser in situ keratomileusis (TG-LASIK) and ray tracing-guided LASIK (RT-LASIK) for the treatment of myopia and myopic astigmatism.
Methods:
This comparative study was conducted between TG-LASIK (P020050/S012; Alcon Laboratories, Inc., Fort Worth, TX, USA) with Allegretto Wave Eye-Q laser and topography-guided custom ablation treatment planning software, and "WaveLight Plus" RT-LASIK (P020050/S043; Alcon Laboratories, Inc.) using the WaveLight EX500 excimer laser and InnovEyes Sightmap. Clinical outcomes were compared, including visual and refractive measures, astigmatic correction, mesopic contrast sensitivity, higher-order aberrations, and patient-reported outcomes.
Results:
This analysis included 249 eyes (212 patients) that underwent TG-LASIK and 336 eyes (168 patients) that underwent RT-LASIK. At 12 months, uncorrected distance visual acuity of 20/16 or better (64.8% TG-LASIK vs. 70.2% RT-LASIK) and 20/20 or better (92.6% TG-LASIK vs. 94.4% RT-LASIK) did not differ statistically between platforms. However, more TG-LASIK eyes had 20/10 or better (15.7% vs. 2.5%, P < 0.001) and 20/12.5 or better (34.4% vs. 26.4%, P = 0.044) than RT-LASIK eyes. Both platforms demonstrated comparable refractive predictability and stability (P > 0.05). For preoperative cylinder between - 1.00 to - 4.00 D, RT-LASIK showed greater astigmatic overcorrection (P < 0.05). At 3 months, RT-LASIK showed higher mesopic contrast sensitivity at 3, 6, and 12 cycles per degree under glare, with more eyes achieving clinically significant gains compared to TG-LASIK (P < 0.001). Both platforms induced changes in total higher-order aberrations, although not clinically significant. RT-LASIK also reduced spherical aberration from baseline. Both procedures showed a reduction in symptom severity for glare, halos, starburst, double vision, and dry eye.
Conclusions:
While TG-LASIK showed superior visual acuity outcomes, RT-LASIK was associated with higher contrast sensitivity; however, both platforms demonstrate excellent visual and refractive outcomes. The majority of published studies are consistent with FDA PMA trends, showing potential reductions in spherical aberration and higher rates of 20/20 or better visual acuity with RT-LASIK.
