Nuzzi Raffaele, Tridico Federico
Institute of Ophthalmology, Department of Surgical Sciences, University of Turin, Via Juvarra 19, 10100, Turin, Italy.
Unit of Ophthalmology, San Luigi Gonzaga University Hospital, University of Turin, Regione Gonzole 10, Orbassano, 10043, Turin, Italy.
BMC Ophthalmol. 2017 Feb 14;17(1):12. doi: 10.1186/s12886-017-0411-9.
The aim of this study was to evaluate visual outcomes for different working distances (far, 60 cm and 33 cm) and impact on vision quality of multifocal IOLs AcrySof ResTOR SN6AD1 and SN6AD3 (Alcon, Inc., Fort Worth, Texas, USA) as well as REVIEW FIL611PV multifocal and OPTOFLEX FIL618 accommodative IOLs (Soleko, Ltd., Rome, Italy) in patients undergoing bilateral phacoemulsification.
In this observational prospective study 63 patients undergoing binocular cataract surgery were divided into four groups for implantation of one of the IOLs under evaluation. Visual outcomes were evaluated at 1 day, 7 days, 1 month, 3 months and 6 months after surgery. Patients' satisfaction and spectacle independence were evaluated with questionnaires administered at the 6-months follow-up.
Improvements in visual acuity for the three working distances were statistically significant in all cases compared to the preoperative status, especially after binocular implantation. The AcrySof ReSTOR SN6AD1 multifocal IOL provided the best visual acuity results and tolerability for all working distances. While performing worse than SN6AD1, FIL611PV and FIL618 provided better uncorrected visual acuity and spectacles independence for intermediate/close-up and far distances respectively, in comparison with the SN6AD3 group.
SN6AD1 was confirmed the best choice for all working distances. However, FIL611PV IOL may represent a valid and more cost-effective alternative, especially if surgeons intend to prioritize spectacle independence and patient autonomy at intermediate and close-up distances, in accordance to specific needs and requests.
Trial retrospectively registered in ISRCTN Registry on 02/02/2017. TRN: ISRCTN14145737 .
本研究旨在评估在接受双眼超声乳化白内障手术的患者中，不同工作距离（远、60厘米和33厘米）下的视觉效果，以及多焦点人工晶状体AcrySof ResTOR SN6AD1和SN6AD3（美国德克萨斯州沃思堡爱尔康公司）以及REVIEW FIL611PV多焦点人工晶状体和OPTOFLEX FIL618可调节人工晶状体（意大利罗马索莱科有限公司）对视觉质量的影响。
在这项观察性前瞻性研究中，63例接受双眼白内障手术的患者被分为四组，分别植入一种正在评估的人工晶状体。在术后1天、7天、1个月、3个月和6个月评估视觉效果。在6个月随访时通过问卷调查评估患者的满意度和脱镜率。
与术前状态相比，所有病例在三种工作距离下的视力改善均具有统计学意义，尤其是在双眼植入后。AcrySof ReSTOR SN6AD1多焦点人工晶状体在所有工作距离下均提供了最佳的视力结果和耐受性。虽然FIL611PV和FIL618的表现不如SN6AD1，但与SN6AD3组相比，它们分别在中/近距离和远距离提供了更好的裸眼视力和脱镜率。
SN6AD1被证实是所有工作距离的最佳选择。然而，FIL611PV人工晶状体可能是一种有效的且更具成本效益的选择，特别是如果外科医生打算根据特定需求和要求，将中近距离的脱镜率和患者自主性作为优先考虑因素。
该试验于2017年2月2日在ISRCTN注册中心进行回顾性注册。注册号：ISRCTN14145737 。
