Journal of refractive surgery (Thorofare, N.J. : 1995) · 2015
Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Bissen-Miyajima Hiroko, Negishi Kazuno, Hieda Osamu, Kinoshita Shigeru
Аннотация
PURPOSE: To evaluate the efficacy and safety of a new acrylic one-piece toric intraocular lens (IOL).
METHODS: This prospective multicenter clinical trial included 93 eyes of 61 patients that were implanted with a hydrophobic acrylic toric IOL from 2010 to 2012 and followed for 1 year. This IOL uses the platform of a microincision one-piece aspheric IOL, the NY-60 IOL (HOYA, Tokyo, Japan), with three increments in cylindrical power (NHT15, 1.5 diopters [D]; NHT23, 2.25 D; and NHT30, 3.0 D). The inclusion criterion was preoperative corneal astigmatism from 0.75 to 3.00 D. The primary endpoint was uncorrected distance visual acuity (UDVA) of 0.0 logMAR (20/20 Snellen) or better 6 months postoperatively. In addition to UDVA, corrected distance visual acuity (CDVA), residual astigmatism, stability of the IOL alignment, need of realignment, and the rate of Nd:YAG laser capsulotomy were evaluated up to 1 year postoperatively. Errors in astigmatic correction were assessed using Alpin's vector analysis.
RESULTS: The primary endpoint was achieved in 54.8% of eyes. One year postoperatively, the logMAR UDVAs were 0.02 ± 0.13, 0.05 ± 0.17, and 0.09 ± 0.14 with models NHT15, NHT23, and NHT30, which corresponds to 0.96 (19/20 Snellen), 0.89 (18/20 Snellen), and 0.82 (16/20 Snellen), respectively. One year postoperatively, the residual astigmatism was 0.66 ± 0.58 D. In each evaluation, the mean absolute change in the position of the axis mark was between 1.93° and 2.32°. Three eyes required repositioning of the IOL axis and 2 eyes received Nd:YAG laser capsulotomy. The correction error showed an undercorrection with against-the-rule astigmatism and overcorrection with with-the-rule astigmatism.
CONCLUSIONS: The new one-piece toric IOL provided desirable clinical outcomes and stability in eyes with corneal astigmatism.
METHODS: This prospective multicenter clinical trial included 93 eyes of 61 patients that were implanted with a hydrophobic acrylic toric IOL from 2010 to 2012 and followed for 1 year. This IOL uses the platform of a microincision one-piece aspheric IOL, the NY-60 IOL (HOYA, Tokyo, Japan), with three increments in cylindrical power (NHT15, 1.5 diopters [D]; NHT23, 2.25 D; and NHT30, 3.0 D). The inclusion criterion was preoperative corneal astigmatism from 0.75 to 3.00 D. The primary endpoint was uncorrected distance visual acuity (UDVA) of 0.0 logMAR (20/20 Snellen) or better 6 months postoperatively. In addition to UDVA, corrected distance visual acuity (CDVA), residual astigmatism, stability of the IOL alignment, need of realignment, and the rate of Nd:YAG laser capsulotomy were evaluated up to 1 year postoperatively. Errors in astigmatic correction were assessed using Alpin's vector analysis.
RESULTS: The primary endpoint was achieved in 54.8% of eyes. One year postoperatively, the logMAR UDVAs were 0.02 ± 0.13, 0.05 ± 0.17, and 0.09 ± 0.14 with models NHT15, NHT23, and NHT30, which corresponds to 0.96 (19/20 Snellen), 0.89 (18/20 Snellen), and 0.82 (16/20 Snellen), respectively. One year postoperatively, the residual astigmatism was 0.66 ± 0.58 D. In each evaluation, the mean absolute change in the position of the axis mark was between 1.93° and 2.32°. Three eyes required repositioning of the IOL axis and 2 eyes received Nd:YAG laser capsulotomy. The correction error showed an undercorrection with against-the-rule astigmatism and overcorrection with with-the-rule astigmatism.
CONCLUSIONS: The new one-piece toric IOL provided desirable clinical outcomes and stability in eyes with corneal astigmatism.