PURPOSE: To compare visual, refractive, and clinical outcomes of foldable iris-fixated phakic intraocular lens (PIOL) implantation versus femtosecond laser-assisted LASIK for myopia between -6.00 and -9.00 diopters (D). METHODS:Forty-six myopic patients were randomized to undergo bilateral Artiflex (Ophtec BV) PIOL implantation or bilateral femtosecond laser-assisted conventional LASIK with the VISX S2 (Abbott Medical Optics). Refraction, uncorrected (UDVA) and corrected (CDVA) distance visual acuity, contrast sensitivity, corneal endothelial cell count, rate of retreatment, and complications were compared. RESULTS: Twelve months after surgery, no statistically significant differences were noted in spherical equivalent refraction (P=.19) or UDVA (P=.28), whereas CDVA was better in the PIOL group (P<.001). Spherical equivalent refraction was within ±0.50 D in 42 (91.3%) LASIK eyes and 41 (89.1%) PIOL eyes (P>.99). The percentage of eyes gaining lines of CDVA was significantly higher in the PIOL group (50.0% vs 8.7%; P<.001). Contrast sensitivity was better for PIOL eyes at 1.5 cycles per degree (cpd) (P=.03) and 6 cpd (P=.008). The LASIK eyes showed a mean endothelial cell count increase of 3.7%±2.8%, whereas PIOL eyes showed a mean decrease of 9.1%±2.0% (P<.001). The rate of retreatment was similar (P=.37), and no serious complications occurred in either group. CONCLUSIONS: The Artiflex PIOL provided better CDVA and contrast sensitivity at high spatial frequencies than femtosecond laser-assisted conventional LASIK, suggesting that PIOL implantation is a reasonable option for myopia between -6.00 and -9.00 D. Copyright 2012, SLACK Incorporated.
RCT Entities:
PURPOSE: To compare visual, refractive, and clinical outcomes of foldable iris-fixated phakic intraocular lens (PIOL) implantation versus femtosecond laser-assisted LASIK for myopia between -6.00 and -9.00 diopters (D). METHODS: Forty-six myopic patients were randomized to undergo bilateral Artiflex (Ophtec BV) PIOL implantation or bilateral femtosecond laser-assisted conventional LASIK with the VISX S2 (Abbott Medical Optics). Refraction, uncorrected (UDVA) and corrected (CDVA) distance visual acuity, contrast sensitivity, corneal endothelial cell count, rate of retreatment, and complications were compared. RESULTS: Twelve months after surgery, no statistically significant differences were noted in spherical equivalent refraction (P=.19) or UDVA (P=.28), whereas CDVA was better in the PIOL group (P<.001). Spherical equivalent refraction was within ±0.50 D in 42 (91.3%) LASIK eyes and 41 (89.1%) PIOL eyes (P>.99). The percentage of eyes gaining lines of CDVA was significantly higher in the PIOL group (50.0% vs 8.7%; P<.001). Contrast sensitivity was better for PIOL eyes at 1.5 cycles per degree (cpd) (P=.03) and 6 cpd (P=.008). The LASIK eyes showed a mean endothelial cell count increase of 3.7%±2.8%, whereas PIOL eyes showed a mean decrease of 9.1%±2.0% (P<.001). The rate of retreatment was similar (P=.37), and no serious complications occurred in either group. CONCLUSIONS: The Artiflex PIOL provided better CDVA and contrast sensitivity at high spatial frequencies than femtosecond laser-assisted conventional LASIK, suggesting that PIOL implantation is a reasonable option for myopia between -6.00 and -9.00 D. Copyright 2012, SLACK Incorporated.