Comparison and analysis of FDA reported visual outcomes of the three latest platforms for LASIK: wavefront guided Visx iDesign, topography guided WaveLight Allegro Contoura, and topography guided Nidek EC-5000 CATz

Abstract

PurposeTo compare and analyze the differences in visual outcomes between Visx iDesign Advanced WaveScan Studio™ System, Alcon Wavelight Allegro Topolyzer and Nidek EC-5000 using Final Fit™ Custom Ablation Treatment Software from the submitted summary of safety and effectiveness of the US Food and Drug Administration (FDA) data.MethodsIn this retrospective comparative study, 334 eyes from Visx iDesign, 212 eyes from Alcon Contour, and 135 eyes from Nidek CATz platforms were analyzed for primary and secondary visual outcomes. These outcomes were compared via side-by-side graphical and tabular representation of the FDA data. Statistical significance was calculated when appropriate to assess differences. A P-value <0.05 was considered statistically significant.ResultsThe mean postoperative uncorrected distance visual acuity (UDVA) at 12 months was 20/19.25±8.76, 20/16.59±5.94, and 20/19.17±4.46 for Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. In at least 90% of treated eyes at 3 months and 12 months, all three lasers showed either no change or a gain of corrected distance visual acuity (CDVA). Mesopic contrast sensitivity at 6 months showed a clinically significant increase of 41.3%, 25.1%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. Photopic contrast sensitivity at 6 months showed a clinically significant increase of 19.2%, 31.9%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively.ConclusionFDA data for the three platforms shows all three were excellent with respect to efficacy, safety, accuracy, and stability. However, there are some differences between the platforms with certain outcome measurements. Overall, patients using all three lasers showed significant improvements in primary and secondary visual outcomes after LASIK surgery.

Study on the Corneal Higher-Order Aberrations and Correlation in Patients with Different Degrees of Myopia Suitable for Wavefront-Guided FS-LASIK

“…China is one of the countries with the highest incidence of myopia in the world, and increasingly many surgeries will be needed every year to allow people to get rid of their glasses [5] [6] [7]. In conventional optics, the image is differentiated into chromatic and monochromatic aberrations [6]. Monochromatic aberrations can be divided into spherical aberration, coma, astigmatism, curvature of field and distortion.…”

Study on the corneal higher-order aberrations and correlation in patients with different degrees of myopia suitable for wavefront-guided FS-LASIK

“…LASIK has emerged as the refractive corneal surgical procedure of choice for the correction of myopia, with approximately 620,000 to 720,000 procedures performed annually in the last 5 years in the US to correct refractive error. China is one of the countries with the highest incidence of myopia in the world, and increasingly many surgeries will be needed every year to allow people to get rid of their glasses [5,6,7].…”

Correlation between higher-order aberrations and visual acuity recovery (CoHORT) after spectacles treatment for pediatric refractive amblyopia: A pilot study using iDesign measurement

“…iDesign (Johnson & Johnson Vision, Santa Ana, CA, USA) is a new-generation aberrometer designed based on Hartmann-Shack theory to eliminate HOAs after refractive surgery and improve final visual quality. Surgery using iDesign is referred to as wavefront-guided refractive surgery and has provided satisfactory results in many patients, so HOAs measured by iDesign may be crucial in determining visual quality [15][16][17][18][19][20][21]. Moreover, iDesign improves accuracy and resolution of HOAs measurements since it has more detection points and greater resolution than other aberrometers [16].…”