虹膜固定型有晶状体眼人工晶状体植入术后远期安全性的临床分析

Clinical analysis of long term safety after implantation of iris-fixed phakic intraocular lens Verisyse

目的研究虹膜固定型有晶状体眼人T晶状体（P—IOL）Verisyse植入眼内矫正高度近视的手术安全性。方法回顾性系列病例研究。随访2005年1月至2007年1月在首都医科大学附属北京同仁医院眼科进行虹膜固定型P—IOL植入的59例（118只眼）高度近视眼患者，其中男性患者32例（64只眼），女性患者27例（54只眼），年龄范围22～39岁，平均（26．6±7，5）岁。术前裸眼视力0．02～0．08，最佳矫正视力0．3～1．0。对其术后远期的并发症、视力、屈光度数、眼压、角膜内皮、P—IOL位置等情况进行观察，时间最短48个月，最长72个月，平均（56．2-4-16．9）个月。数据采用配对￡检验及Fisher确切概率法进行统计分析。结果术后有8只眼（6．78％）发生了P-IOL脱位于前房；7只眼（5．93％）出现了角膜内皮细胞计数较术前丢失〉1000个／mm2，其中1只眼（0．84％）发生了角膜内皮失代偿，其余术眼术后角膜内皮细胞计数[（2249±654）个／mm2]与手术前测的[（2821±117）个／mm2]差异无统计学意义（t=1．112，P=0．09）；2只眼（1．69％）发生了视网膜脱离。除发生角膜内皮失代偿和视网膜脱离的患者外，裸眼视力较术前提高5至8行，最佳矫正视力均较术前提高1至3行。术后远期等效球镜与术后3个月相比，差异无统计学意义（t=0．641，P=0．21）。眼压平均（16．4±3．4）mmHg（1mmHg=0．133kPa）。除发生半脱位的手术眼外，P—IOL光学部前表面与角膜内皮距离（2．468±0．342）mm，后表面与晶状体距离（0．652±0．176）mm。光学部边缘最高点与角膜内皮距离（1．728±0．213）mm。嵌夹入虹膜组织过少或错位嵌夹的情况下，手术眼更容易发生Verisyse脱位，与正确对合嵌夹相比，差异有统计学意义（P=0．000）。所有患者在术后远期未发生继发性青光眼。结论虹膜固定型P—IOLVerisyse植入能有效矫正高度近视，但对角膜内皮细胞有一定程度的损伤，后者可能与其在前房内的不稳定有关。该IOL的长期安全性值得临床关注。

[Abstract] Objective To analyze the long-term safety of implantation of iris-fixed phakic intraocular lens （IOL） Vefisyse for the treatment of high myopia. Methods One hundred and eighteen eyes of 59 cases implanted Verisyse for high myopia in Eye Center of Tongren Hospital from Jan. 2005 to Jan. 2007 were followed up for 48 to 72 months, mean time period was （56.2 ＋_ 16. 9 ） months. There were 32 male cases （64 eyes） and 27 female cases （54 eyes）. Age ranged from 22 to 39 years old, mean（26. 6 -＋ 7.5 ） years. The uncorrected vision acuity was 0. 02 - 0. 08, and the best corrected vision acuity was 0. 3 - 1.0. The visual acuity, refraction, intraocular pressure, corneal endothelimn and the distance between Verisyse to corneal and lens was measured separately, and the complications were also observed. The results were treated with analysis of paired-samples t test and Fisher exact probability test. A difference at P 〈 0. 05 was considered to be statistically significant. Results The complications included the dislocation of Verisyse into anterior chamber in 8 cases （8 eyes, 6. 78% ）, retina detachment in 2 cases （2 eyes, 1.69% ） , corneal endothelium lost more than 1000/mm2 in 6 cases （7 eyes, 5.93% ） , corneal edema in 1 case （1 eye, 0. 84% ）. Pre-operative mean corneal endothelium density was （2821 ± 117）/mm2, and it was （ 2249± 654 ）/mm2 after surgery. There was no significant difference （ t = 1.112, P = 0. 09 ） between pre- and post-operative data. Post-operative uncorrected vision improved 5 to 8 lines than that of pre-operation. Post-operative corrected vision improved 1 to 3 lines than that of pre-operation except 1 ease （ 1 eye ） developed corneal decompensation and 2 eases （2 eyes ） developed retina detachment. SE showed no significant difference in long-term after operation compared with 3 months after surgery （ t = 0. 641, P = 0. 21 ）. The mean intraocular pressure was（ 16. 4 ± 3.4） mm Hg（ 1 mm Hg = 0. 133 kPa）. The distance between anterior surface of IOL and endothelium was （ 2. 468 ± 0. 342 ） ram, distance between posterior surface of IOL and lens was （ 0. 652 ± 0. 176 ） mm, and distance between edge of IOL and peripheral endothelium was （ 1. 728 ± 0. 213 ） mm except eyes occurred Verisyse dislocation. Verisyse dislocation occurred more commonly when the iris was not perfectly erapped in the loop, and the difference was significant （ P = 0. 000 ）. No glaucoma occurred. Conclusions Implantation of Verisyse can correct high myopia effectively. But it damages corneal endothelinm in some cases. This complication may be related to the unstable position of Verisyse in the anterior chamber. So we should pay more attention to the safety of this kind of phakie IOL clinically.