Journal of refractive surgery (Thorofare, N.J. : 1995) · 2008
Comparison of the toric implantable collamer lens and custom ablation LASIK for myopic astigmatism.
Сравнительное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sanders Donald R, Sanders Monica L
Аннотация
PURPOSE: To compare the results of wavefront-guided custom LASIK and the Toric Implantable Collamer Lens (TICL) in the correction of myopic astigmatism.
METHODS: This observational, non-randomized study compared clinical efficacy results from the TICL's US Food and Drug Administration Clinical Trial and published Summaries of Safety and Effectiveness of two wavefront-guided lasers: STAR S4 CustomVue excimer laser system (VISX Inc) and LADARVision4000 CustomCornea excimer laser system (Alcon Laboratories Inc). Preoperative myopic refractive error was divided into two groups: -3.00 to -7.00 diopters (D) and -7.00 to -11.00 D.
RESULTS: The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 and 20/40 and predictability of manifest refraction spherical equivalent within +/- 0.50 and +/- 1.00 D in the three groups was similar with only one statistically significant difference (TICL versus Alcon within +/- 1.00 D: 97% versus 82%; P = .008). The TICL had significantly better postoperative best spectacle-corrected visual acuity (BSCVA) compared to preoperative BSCVA than both the VISX CustomVue and Alcon CustomCornea (P < .001). The TICL postoperative UCVA outcomes compared to preoperative BSCVA were significantly better than Alcon CustomCornea outcomes (P < .001). Additionally, almost half (48%) of the TICL cases had improvement in postoperative UCVA compared to preoperative BSCVA, whereas only 23% of the Alcon CustomCornea eyes showed improvement.
CONCLUSIONS: Although comparable in clinical efficacy outcomes, the TICL had a significantly better postoperative improvement in BSCVA and significantly better postoperative UCVA than preoperative BSCVA. The TICL can be considered as an alternative to LASIK through the full range of use.
METHODS: This observational, non-randomized study compared clinical efficacy results from the TICL's US Food and Drug Administration Clinical Trial and published Summaries of Safety and Effectiveness of two wavefront-guided lasers: STAR S4 CustomVue excimer laser system (VISX Inc) and LADARVision4000 CustomCornea excimer laser system (Alcon Laboratories Inc). Preoperative myopic refractive error was divided into two groups: -3.00 to -7.00 diopters (D) and -7.00 to -11.00 D.
RESULTS: The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 and 20/40 and predictability of manifest refraction spherical equivalent within +/- 0.50 and +/- 1.00 D in the three groups was similar with only one statistically significant difference (TICL versus Alcon within +/- 1.00 D: 97% versus 82%; P = .008). The TICL had significantly better postoperative best spectacle-corrected visual acuity (BSCVA) compared to preoperative BSCVA than both the VISX CustomVue and Alcon CustomCornea (P < .001). The TICL postoperative UCVA outcomes compared to preoperative BSCVA were significantly better than Alcon CustomCornea outcomes (P < .001). Additionally, almost half (48%) of the TICL cases had improvement in postoperative UCVA compared to preoperative BSCVA, whereas only 23% of the Alcon CustomCornea eyes showed improvement.
CONCLUSIONS: Although comparable in clinical efficacy outcomes, the TICL had a significantly better postoperative improvement in BSCVA and significantly better postoperative UCVA than preoperative BSCVA. The TICL can be considered as an alternative to LASIK through the full range of use.