Küchle M, Langenbucher A, Gusek-Schneider G C, Seitz B, Hanna K D
Augenklinik mit Poliklinik der Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054 Erlangen, Germany.
Klin Monbl Augenheilkd. 2001 Sep;218(9):603-8. doi: 10.1055/s-2001-17638.
Conventional posterior chamber intraocular lenses (PCIOL) generally provide excellent visual acuity but do not restore accommodation. A new, potentially accommodative PCIOL has been designed after principles elaborated by K.D. Hanna using finite element models. However, before newly developed PCIOL may be implanted routinely in larger numbers of patients, careful and meticulous evaluation in clinical studies is necessary. Thus, it was the aim of this study to investigate intra- and early 3-month postoperative findings after implantation of the newly designed PCIOL.
In a prospective pilot and safety study that was approved by the ethics committee of our university, six eyes of six patients (2 males, 4 females, age range 54 to 87 years) with senile or presenile cataract underwent phacoemulsification and implantation of the new PCIOL by one surgeon between June and November 2000. The PCIOL (1 CU, HumanOptics AG, Erlangen, Germany) is a one-piece hydrophilic acrylic foldable lens with an optic diameter of 5.5 mm. Modified haptics are intended to allow anterior movement of the lens optic as a function of contraction of the ciliary muscle. Intra- and early postoperative findings obtained after one and two days, one, two and six weeks and 3 months postoperatively were documented prospectively. Postoperative examinations included recording of distance and near visual acuity both obtained with best distance correction, determination of subjective near point and measurement of distance and near refraction by streak retinoscopy. Follow-up was at least three months in all patients.
Surgery was uncomplicated in all patients with successful in-the-bag implantation and good centration of the PCIOL. The postoperative course was uncomplicated without inflammation, hemorrhage, synechiae or decentration. Visual acuity improved in all patients according to the status of the macula with values between 20/200 (atrophic maculopathy) and 20/20. After three to six months we observed a difference between retinoscopic near and distance refraction of 0.625 to 1.875 D and subjective near points of 40 to 100 cm. Near visual acuity with distance correction ranged from 0.1 or J 16 (atrophic maculopathy) to 0.4 or J 7.
These early and preliminary results of our small pilot study are encouraging. Our findings may indicate at least some degree of pseudophakic accommodation. However, further studies with additional methods of measurements, with longer follow-up, more patients and controlled studies with control groups are essential to further determine safety and potential accommodative power of this new PCIOL.
传统后房型人工晶状体(PCIOL)通常能提供出色的视力,但无法恢复调节功能。一种新型的、具有潜在调节功能的PCIOL已依据K.D. Hanna阐述的原理并使用有限元模型设计而成。然而,在这种新研发的PCIOL能够常规大量植入更多患者体内之前,有必要在临床研究中进行仔细且严谨的评估。因此,本研究的目的是调查新型设计的PCIOL植入后的术中及术后3个月早期的情况。
在一项经我校伦理委员会批准的前瞻性试点及安全性研究中,2000年6月至11月期间,一名外科医生为6例患者(2例男性,4例女性,年龄范围54至87岁)的6只眼睛实施了老年性或早老性白内障超声乳化吸除术并植入新型PCIOL。该PCIOL(1 CU,德国埃尔朗根市HumanOptics AG公司)是一片式亲水性丙烯酸可折叠人工晶状体,光学直径为5.5毫米。改良的襻旨在使晶状体光学部能够根据睫状肌的收缩而向前移动。前瞻性记录了术后1天和2天、1周、2周、6周以及3个月时的术中及早期术后情况。术后检查包括记录在最佳远视力矫正下的远视力和近视力、主观近点的测定以及通过带状检影法测量远屈光和近屈光。所有患者的随访时间至少为3个月。
所有患者手术均顺利,人工晶状体成功植入囊袋内且居中良好。术后过程顺利,无炎症、出血、粘连或偏位情况。根据黄斑状况,所有患者的视力均有所提高,视力值在20/200(萎缩性黄斑病变)至20/20之间。三至六个月后,我们观察到检影法测量的近屈光与远屈光差值为0.625至1.875 D,主观近点为40至100厘米。在远视力矫正下的近视力范围为0.1或J 16(萎缩性黄斑病变)至0.4或J 7。
我们这项小型试点研究的这些早期初步结果令人鼓舞。我们的发现可能表明至少存在一定程度的人工晶状体调节功能。然而,要进一步确定这种新型PCIOL的安全性和潜在调节能力,还需要采用更多测量方法、进行更长时间的随访、纳入更多患者并开展有对照组的对照研究。