Srinivasan Sathish, Scharioth Gabor, Riehl Anneliese, Tanev Ivan V, Rozsival Pavel, Acker Emmanuel Van, Nagy Zoltan Z, Balta Florian, Nekolova Jana
Department of Ophthalmology, University Hospital, Ayr, UK
University of West of Scotland, Ayr, Scotland, UK.
BMJ Open Ophthalmol. 2019 Jul 7;4(1):e000322. doi: 10.1136/bmjophth-2019-000322. eCollection 2019.
To report the visual and refractive outcomes following monocular implantation of a supplementary (piggyback) Scharioth macula lens (SML) in previously pseudophakic eyes with age-related macular degeneration (AMD).
Prospective European multicentre clinical trial. 50 eyes of 50 pseudophakic patients with either dry or previously treated and stable neovascular AMD for at least 6 months were included. The inclusion criteria were age over 55, corrected distance visual acuity (CDVA) of 0.4-0.1 (decimal), improvement of at least three lines of corrected near visual acuity (CNVA) when tested with a +6.0 dioptre (D) reading addition at 15 cm, compared with a +2.5 D reading addition at 40 cm using a standardised, self-illuminated Early Treatment Diabetic Retinopathy Study near vision chart. The SML intraocular lens (IOL) was implanted as an add-on/piggyback IOL in the ciliary sulcus, monocularly in the better seeing eye of each subject meeting the inclusion criteria.
There were no intraoperative complications. One subject had the SML explanted in the postoperative period due to postoperative glare/halos. The mean CNVA improved from 0.23±0.12 (decimal) preoperatively to 0.57±0.33 at 1 year. The mean CDVA remained unchanged measuring 0.19±0.13 preoperatively and 0.19±0.09 at 1 year postoperatively.
The SML appears to be safe and effective in improving the CNVA in patients with AMD. Data suggest that the CDVA remains unaffected following implantation. Further data are needed to assess the long-term safety and efficacy.
报告在先前已植入人工晶状体且患有年龄相关性黄斑变性（AMD）的单眼中植入补充性（背负式）沙里奥思黄斑晶状体（SML）后的视觉和屈光结果。
欧洲前瞻性多中心临床试验。纳入了50例人工晶状体眼患者的50只眼，这些患者患有干性或先前已治疗且稳定的新生血管性AMD至少6个月。纳入标准为年龄超过55岁，矫正远视力（CDVA）为0.4 - 0.1（小数），与使用标准化自发光早期治疗糖尿病性视网膜病变研究近视力表在40 cm处使用+2.5 D附加镜测试相比，在15 cm处使用+6.0屈光度（D）附加镜测试时矫正近视力（CNVA）至少提高三行。SML人工晶状体（IOL）作为附加/背负式IOL植入睫状沟，单眼植入符合纳入标准的每个受试者视力较好的眼中。
术中无并发症。1例受试者在术后因术后眩光/光晕而取出SML。平均CNVA从术前的0.23±0.12（小数）提高到1年时的0.57±0.33。平均CDVA保持不变，术前测量为0.19±0.13，术后1年为0.19±0.09。
SML在改善AMD患者的CNVA方面似乎是安全有效的。数据表明植入后CDVA不受影响。需要进一步的数据来评估长期安全性和有效性。
