Gasser Laura, Biermann Julia, Reinhard Thomas
From the Eye Center, University Hospital Freiburg, Freiburg, Germany.
From the Eye Center, University Hospital Freiburg, Freiburg, Germany.
J Cataract Refract Surg. 2015 Aug;41(8):1610-5. doi: 10.1016/j.jcrs.2014.11.052.
To present the 3-year results regarding the safety and efficacy of the Epi.Lens N, a new posterior chamber phakic intraocular lens (PC pIOL).
Eye Center, University Hospital Freiburg, Freiburg, Germany.
Prospective clinical study.
A PC pIOL was implanted in highly myopic eyes of consecutive patients. Standardized follow-up examinations including uncorrected (UDVA) and corrected (CDVA) distance visual acuities and refractions were performed 1, 3, and 6 months and 1, 2, and 3 years postoperatively.
The patient cohort consisted of 30 eyes of 16 patients. The study eyes had a mean manifest refraction spherical equivalent of -10.1 diopters (D) ± 3.4 (SD), which decreased to -0.3 ± 0.8 D postoperatively. After 3 years, all eyes achieved (47%) or exceeded (53%) their preoperative CDVA, thus improving the mean CDVA from 20/21 (0.94) preoperatively to 20/18 (1.14) postoperatively. The mean postoperative UDVA (20/20 [0.98]) resembled the preoperative CDVA (20/21 [0.94]). When analyzing all eyes with good visual potential (preoperative CDVA 20/20 or better; n = 18), 94% achieved a postoperative UDVA of 20/20 or better. One small-diameter PC pIOL contacted the crystalline lens, which led to slight anterior subcapsular lens opacification. Despite this, the patient achieved a CDVA of 20/20.
The 3-year results of this pilot study of a new PC pIOL showed good efficacy and safety.
No author has a financial or proprietary interest in any material or method mentioned.
展示新型后房型有晶状体眼人工晶状体(PC pIOL)Epi.Lens N的3年安全性和有效性结果。
德国弗莱堡大学医院眼科中心。
前瞻性临床研究。
将PC pIOL植入连续患者的高度近视眼中。术后1、3和6个月以及1、2和3年进行标准化随访检查,包括未矫正远视力(UDVA)和矫正远视力(CDVA)以及验光。
患者队列包括16例患者的30只眼。研究眼术前平均显性验光球镜等效度为-10.1屈光度(D)±3.4(标准差),术后降至-0.3±0.8 D。3年后,所有眼均达到(47%)或超过(53%)其术前CDVA,因此平均CDVA从术前的20/21(0.94)提高到术后的20/18(1.14)。术后平均UDVA(20/20 [0.98])与术前CDVA(20/21 [0.94])相似。分析所有具有良好视力潜能的眼(术前CDVA 20/20或更好;n = 18),94%的眼术后UDVA达到20/20或更好。一枚小直径PC pIOL接触晶状体,导致晶状体前囊下轻度混浊。尽管如此,该患者的CDVA仍达到20/20。
这项新型PC pIOL的初步研究的3年结果显示出良好的有效性和安全性。
没有作者对文中提及的任何材料或方法拥有财务或专利权益。