Vounotrypidis Efstathios, Lackerbauer Carlo, Kook Daniel, Dirisamer Martin, Priglinger Siegfried, Mayer Wolfgang J
Department of Ophthalmology, Ludwig Maximilians University of Munich, Munich, Germany.
Oman J Ophthalmol. 2018 May-Aug;11(2):144-149. doi: 10.4103/ojo.OJO_143_2017.
Intraocular lenses with variable total diameter are supposed to fit better in the capsular bag and lead to fewer complications.
This study aims to investigate the efficacy and the safety of an intraocular lens model with variable total diameter.
Prospective randomized intraindividual study.
Thirty-two eyes of sixteen patients with bilateral age-related cataract received standard cataract surgery with implantation of an intraocular lens with a standard diameter in one eye (Quatrix®, Group A) and with a variable total diameter in the fellow eye (Quatrix Evolutive®, Group B). Primary study endpoints included evaluation of refraction stability and posterior capsule opacification (PCO) over a follow-up period of 6 months.
SPSS (Version 19.0) was used for statistical analysis.
Uncorrected and corrected distant visual acuity after 6 months were 0.24 and 0.1 LogMAR in Group A and 0.23 and 0.09 LogMAR in Group B, respectively. The objective and manifest spherical equivalent (OSE, MSE) 6 months postoperatively were + 0.65 D and + 0.62 D in Group A compared to + 0.33 D and + 0.33 D in Group B respectively ( = 0.665 for OSE, = 0.208 for MSE). PCO-index increased statistically significant in both groups ( = 0.004 in Group A, = 0.046 in Group B), but the difference of PCO-index between both groups was not statistically significant ( = 0.569).
An intraocular lens with a variable total diameter shows good visual outcomes and safety performance as well as same outcomes concerning postoperative refractive stability and development of PCO compared to an intraocular lens with standard total diameter.
具有可变总直径的人工晶状体被认为能更好地适配于晶状体囊袋,并减少并发症的发生。
本研究旨在探讨一种具有可变总直径的人工晶状体模型的有效性和安全性。
前瞻性随机个体内研究。
16例双侧年龄相关性白内障患者的32只眼接受了标准白内障手术,其中一只眼植入标准直径的人工晶状体(Quatrix®,A组),另一只眼植入可变总直径的人工晶状体(Quatrix Evolutive®,B组)。主要研究终点包括在6个月的随访期内评估屈光稳定性和后囊膜混浊(PCO)情况。
使用SPSS(版本19.0)进行统计分析。
6个月后,A组的未矫正和矫正远视力分别为0.24和0.1 LogMAR,B组分别为0.23和0.09 LogMAR。术后6个月,A组的客观和明显球镜等效度(OSE,MSE)分别为 +0.65 D和 +0.62 D,而B组分别为 +0.33 D和 +0.33 D(OSE的P = 0.665,MSE的P = 0.208)。两组的PCO指数均有统计学显著增加(A组P = 0.004,B组P = 0.046),但两组之间PCO指数的差异无统计学意义(P = 0.569)。
与具有标准总直径的人工晶状体相比,具有可变总直径的人工晶状体在视觉效果和安全性能方面表现良好,在术后屈光稳定性和PCO发生方面也具有相同的结果。