Dick H Burkhard, Schultz Tim, Lesieur Gilles, Morselli Simonetta, Toso Antonio, Alio Jorge L, Buckhurst Phillip J, Johansson Björn
University Eye Hospital Bochum, In der Schornau 23-25, 44892, Bochum, Germany.
Centre Ophtalmologique Iridis, Albi, France.
Int Ophthalmol. 2019 May;39(5):1043-1054. doi: 10.1007/s10792-018-0905-3. Epub 2018 Apr 13.
To evaluate clinical outcomes following sub-2-mm microincision cataract surgery (MICS) and intraocular lens (IOL) implantation.
Five EU clinical sites.
Prospective, multicenter, open-label, single-arm, non-randomized.
Preoperative assessment involved visual acuity (VA), intraocular pressure and biometry measurements. 1.4-mm wound-assisted or 1.8-mm MICS was performed. Follow-up visits were made 1 day, 1-2 weeks, 1-2 and 4-6 months after surgery. The incision size, corrected distance VA (CDVA), uncorrected distance VA, manifest refraction spherical equivalent (MRSE), refraction predictability/stability and IOL decentration were assessed. At 12-, 18-, and 24-month, long-term centration, posterior capsular opacification (PCO) and Nd:YAG capsulotomy rates were investigated.
A total of 103 eyes were implanted with the study IOL (INCISE, Bausch & Lomb), 96 of which were included in visual outcome analysis. A mean 6-month CDVA of - 0.02 logMAR (20/20 + 1) was observed and 75 eyes (79.8%) and 93 eyes (98.3%) achieved a visual acuity of at least 20/20 or 20/40. Mean MRSE was - 0.20 ± 0.60 D. Mean absolute predictive error was 0.44 ± 0.36 D, with 90.4% within 1.00 D of target. Mean total decentration was 0.35 ± 0.36 mm at 6 months and 0.32 ± 0.14 mm at 24 months (p > 0.05). 24-month evaluation of posterior capsular opacification score was 0.03 for the central area. A Nd:YAG rate of 3.4% was observed at 24 months.
The new MICS IOL provided excellent visual outcomes and was safe and effective for the sub-2-mm procedure. The MICS IOL demonstrated long-term centration, stability and a low rate of PCO development.
评估2毫米以下微切口白内障手术（MICS）及人工晶状体（IOL）植入后的临床效果。
五个欧盟临床站点。
前瞻性、多中心、开放标签、单臂、非随机。
术前评估包括视力（VA）、眼压及生物测量。实施1.4毫米伤口辅助或1.8毫米MICS手术。术后1天、1 - 2周、1 - 2个月及4 - 6个月进行随访。评估切口大小、矫正远视力（CDVA）、未矫正远视力、明显屈光球镜等效度（MRSE）、屈光预测性/稳定性及IOL偏心情况。在12个月、18个月及24个月时，调查长期中心定位、后囊膜混浊（PCO）及Nd:YAG囊膜切开率。
共103只眼植入研究用IOL（INCISE，博士伦公司），其中96只眼纳入视力结果分析。观察到平均6个月CDVA为 -0.02 logMAR（20/20 +1），75只眼（79.8%）及93只眼（98.3%）达到至少20/20或20/40的视力。平均MRSE为 -0.20±0.60 D。平均绝对预测误差为0.44±0.36 D，90.4%在目标值1.00 D范围内。6个月时平均总偏心度为0.35±0.36毫米，24个月时为0.32±0.14毫米（p>0.05）。24个月时后囊膜混浊中央区评分为0.03。24个月时Nd:YAG切开率为3.4%。
新型MICS IOL提供了优异的视力结果，对于2毫米以下手术安全有效。MICS IOL显示出长期中心定位、稳定性及低PCO发生率。
