Alio Jorge L, Simonov Aleksey, Plaza-Puche Ana Belén, Angelov Alexander, Angelov Yavor, van Lawick Willem, Rombach Michiel
Vissum Alicante, Alicante, Spain; Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain.
AkkoLens Clinical b.v., Breda, Netherlands.
Am J Ophthalmol. 2016 Apr;164:37-48. doi: 10.1016/j.ajo.2016.01.006. Epub 2016 Jan 29.
To compare visual acuity, accommodation, and contrast sensitivity of the AkkoLens Lumina accommodative intraocular lens (AkkoLens Clinical b.v., Breda, The Netherlands) with a standard monofocal intraocular lens (IOL).
Randomized clinical trial.
The study enrolled 86 eyes with cataract that all required cataract surgery and IOL implantation. The study group included 61 eyes that were implanted with the Lumina. The control group included 25 eyes that were implanted with an Acrysof SA60AT (Alcon, Fort Worth, TX, USA) monofocal IOL. The distance and near visual acuities, contrast sensitivity, and accommodation were measured over a 1-year follow-up period. Accommodation was measured subjectively, using defocus curves, and objectively, with an open-field autorefractor.
Uncorrected (UDVA) and corrected (CDVA) distance visual acuities did not differ significantly between the groups (P ≥ .21) over the 12 months. However, the uncorrected near visual acuity (UNVA) was 0.07 ± 0.08 logRAD for the Lumina group and 0.37 ± 0.19 logRAD for the control group (P < .01) and the corrected distance near visual acuity (CDNVA) was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from -4.50 to -0.50 diopters (D) (P < .01) with significantly higher visual acuities for the Lumina group. Subjective accommodation, as determined from defocus curves, was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and 3.67 ± 0.75 D for the control group at visual acuities of 0.10, 0.20, and 0.4 logMAR for both groups, respectively. The objective accommodation, measured by an open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, 0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group and 0.10 ± 0.15, 0.12 ± 0.15, -0.06 ± 0.09 and 0.07 ± 0.10 D for the control group at accommodation stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast sensitivity was the same for both groups (P ≥ .26).
The Lumina accommodative IOL effectively restores the visual function, accommodation, and contrast sensitivity after cataract surgery with no influence on the postoperative contrast sensitivity.
比较AkkoLens Lumina可调节人工晶状体(AkkoLens Clinical b.v.,荷兰布雷达)与标准单焦点人工晶状体的视力、调节功能和对比敏感度。
随机临床试验。
该研究纳入了86只患有白内障且均需要进行白内障手术和人工晶状体植入的眼睛。研究组包括61只植入Lumina人工晶状体的眼睛。对照组包括25只植入Acrysof SA60AT(美国爱尔康公司,得克萨斯州沃思堡)单焦点人工晶状体的眼睛。在1年的随访期内测量远视力和近视力、对比敏感度以及调节功能。调节功能通过散焦曲线进行主观测量,并使用开放式自动验光仪进行客观测量。
在12个月期间,两组间的未矫正远视力(UDVA)和矫正远视力(CDVA)无显著差异(P≥0.21)。然而,Lumina组的未矫正近视力(UNVA)为0.07±0.08 logRAD,对照组为0.37±0.19 logRAD(P<0.01);Lumina组的矫正远中视力(CDNVA)为0.11±0.12 LogRAD,对照组为0.41±0.15 LogRAD(P<0.01)。散焦曲线显示,在-4.50至-0.50屈光度(D)的散焦范围内,两组间存在统计学显著差异(P<0.01),Lumina组的视力明显更高。根据散焦曲线确定的Lumina组主观调节功能,在两组视力分别为0.10、0.20和0.4 logMAR时,分别为3.05±1.06、3.87±1.27和5.59±1.02 D;对照组分别为1.46±0.54、2.00±0.52和3.67±0.75 D。通过开放式自动验光仪测量的Lumina组客观调节功能,在调节刺激为2.0、2.5、3.0和4.0 D时,分别为0.63±0.41、0.69±0.45、0.91±0.51和1.27±0.76 D;对照组分别为0.10±0.15、0.12±0.15、-0.06±0.09和0.07±0.10 D。两组的对比敏感度相同(P≥0.26)。
Lumina可调节人工晶状体在白内障手术后能有效恢复视觉功能、调节功能和对比敏感度,且对术后对比敏感度无影响。