Lehmann Robert, Waycaster Curtis, Hileman Kendra
Baylor College of Medicine, Houston, TX, USA.
Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.
The primary objective of this research was to compare cataract patient-reported outcomes of subjects bilaterally implanted with apodized diffractive intraocular lenses (AD-IOL) to subjects bilaterally implanted with conventional monofocal intraocular lenses (CM-IOL). A secondary objective was to establish the relationship between uncorrected visual acuity and patient-reported outcomes.
This was a prospective non-randomized, open-label clinical trial consisting of 339 patients bilaterally implanted with the AD-IOL and 156 bilaterally implanted with the CM-IOL. The outcomes of both groups were assessed 6 months postoperatively after second eye implantation. Assessed endpoints included patient-reported outcomes and visual acuity. Limitations of this study include the lack of random assignment to treatment groups and lack of masking of both the physicians and patients.
AD-IOL patients demonstrated significantly better uncorrected near visual acuity (UCNVA) compared to CM-IOL patients (0.02 versus 0.41 log MAR [logarithm of the minimum angle of resolution], respectively; p < 0.0001). UCNVA was significantly correlated with nine patient-reported outcomes in the AD-IOL group and two patient-reported outcomes in the CM-IOL group. Significantly more AD-IOL patients reported spectacle independence compared to CM patients (80% versus 8% respectively; p < 0.0001). AD-IOL patients reported their vision quality as better than CM-IOL patients (p < 0.0001). AD-IOL patients were more satisfied with their daytime (p < 0.0001), nighttime (p < 0.0001), and overall (p < 0.0001) vision than CM-IOL patients. AD-IOL patients reported less trouble with their daytime (p < 0.0001) and nighttime (p = 0.0238) vision compared to CM-IOL patients. Furthermore, AD-IOL patients reported less distance vision limitation (p = 0.0282), less near vision limitation (p < 0.0001), and less social limitation (p < 0.0001) than CM-IOL patients.
The patient reported near vision benefits of the AD-IOL coupled with its high rate of spectacle independence significantly improved cataract patients' health-related quality-of-life, compared to a CM-IOL.
本研究的主要目的是比较双侧植入变迹衍射人工晶状体(AD-IOL)的受试者与双侧植入传统单焦点人工晶状体(CM-IOL)的受试者的白内障患者报告结局。次要目的是确定未矫正视力与患者报告结局之间的关系。
这是一项前瞻性非随机、开放标签的临床试验,包括339例双侧植入AD-IOL的患者和156例双侧植入CM-IOL的患者。在第二只眼植入术后6个月评估两组的结局。评估的终点包括患者报告结局和视力。本研究的局限性包括缺乏对治疗组的随机分配以及医生和患者均未设盲。
与CM-IOL患者相比,AD-IOL患者表现出明显更好的未矫正近视力(UCNVA)(分别为0.02与0.41最小分辨角对数[log MAR];p<0.0001)。在AD-IOL组中,UCNVA与9项患者报告结局显著相关,在CM-IOL组中与2项患者报告结局显著相关。与CM患者相比,报告无需眼镜的AD-IOL患者明显更多(分别为80%与8%;p<0.0001)。AD-IOL患者报告其视力质量优于CM-IOL患者(p<0.0001)。与CM-IOL患者相比,AD-IOL患者对其白天(p<0.0001)、夜间(p<0.0001)及总体(p<0.0001)视力更满意。与CM-IOL患者相比,AD-IOL患者报告其白天(p<0.0001)和夜间(p=0.0238)视力问题更少。此外,与CM-IOL患者相比,AD-IOL患者报告的远视力受限(p=0.0282)、近视力受限(p<0.0001)和社交受限(p<0.0001)更少。
与CM-IOL相比,患者报告的AD-IOL近视力益处及其高比例的无需眼镜状态显著改善了白内障患者与健康相关的生活质量。