Five-year follow-up after anterior iris-fixated intraocular lens implantation in phakic eyes to correct high myopia

Purpose

To evaluate the 5-year follow-up of safety, efficacy, predictability, stability, and complications of anterior iris-fixated phakic intraocular lens (pIOL) implantation to correct high myopia, and patients'' satisfaction after implantation.

Design

Prospective, nonrandomized, and comparative (self-controlled) trial.

Methods

A prospective clinical trial of 84 eyes of 43 patients with high myopia was conducted. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, endothelial cell count, intraocular pressure (IOP), anterior chamber depth, slit lamp biomicroscopy, and indirect ophthalmoscope were measured preoperatively and postoperatively.

Results

At the 5-year follow-up, UCVA was significantly improved, with 85.7% of eyes reaching 20/25 or better. No eyes experienced a loss in BSCVA, and 71.4% gained one or more lines of their preoperative BSCVA. There was a significant reduction in spherical errors in all patients after operation. Loss of endothelial cells was observed 3 years after operation and no more loss was observed 4 years after operation in statistical analysis. No increase in IOP was observed 5 years after operation in statistical analysis. No intraoperative complications were observed in this study. However, pigment precipitates of varying intensities on the lens optic were noted in all patients 1 day after operation, and only five eyes were observed to have the pigment residual five years after operation.

Conclusion

At the 5-year follow-up, the implantation of the anterior iris-fixated pIOL was proved to be effective, predictable and capable of reversibility to correct high myopia in phakic eyes. It was a safety addition to the laser refractive surgery. However, longer follow-up with larger numbers of patients is still necessary to evaluate long-term complications.     

有晶状体眼虹膜固定型人工晶状体植入术后再手术原因及安全性

目的 探讨有晶状体眼虹膜固定型人工晶状体（PIOL）植入术后再手术原因以及长期眼内植入的安全性。方法 回顾性系列病例研究。选择2006年1月至2016年12月于青岛眼科医院白内障科接受有晶状体眼虹膜固定型PIOL植入术治疗高度近视后接受再次眼内手术治疗的患者11例（17眼）。分析再次手术的时间、方式以及原因。数据采用配对t检验进行分析。结果 再次手术的时间为PIOL植入术后6~108个月。12眼（12/17）因为外伤导致PIOL脱位于前房而接受了再次手术,该12眼再手术前角膜内皮细胞计数与植入术前比较,出现不同程度下降（t=5.968,P<0.001）,其中1眼因脱位时间较长（1个月）而最终出现角膜内皮细胞功能失代偿。另有2眼（2/17）虽未出现PIOL脱位,但由于PIOL所夹虹膜较少或部分萎缩,PIOL位置松动,角膜内皮细胞非预期性明显减少,从而接受了人工晶状体再固定术;1眼（1/17）因为对侧眼PIOL脱位,角膜内皮细胞计数下降明显,患者出于恐慌,而决定手术取出PIOL;1例（1眼）患者（1/17）因为PIOL植入后出现视网膜脱离接受了视网膜复位手术,由于术后长期俯卧位,对侧眼（1/17）角膜内皮细胞计数下降明显（658个/mm²）而接受PIOL再固定手术。结论 外伤后PIOL脱位,PIOL松动后非预期性角膜内皮细胞计数下降是有晶状体眼虹膜固定型PIOL植入术后再次手术的主要原因。对于长期植入的患者需增加随访排查潜在的安全隐患。     

虹膜固定型有晶状体眼人工晶状体植人术矫治高度近视29例疗效观察

目的探讨高度近视眼行虹膜固定型有晶状体眼人工晶状体植入术的安全性和有效性。方法选取在本中心接受虹膜固定型有晶状体眼人工晶状体植入术29例（54眼）。术前矫正屈光度数为-10．00～-23．00D,最佳矫正远视力0．1—0．8。术中植入虹膜固定型人工品状体,术后平均随访12个月。观察指标包括：术前及术后的裸眼视力、矫正视力、眼压、瞳孔形态及角膜内皮计数,并对获得的数据进行统计学分析。结果术后1年裸眼视力为0．2～1．0,最佳矫正远视力为0．3-1．2,和术前最佳矫正远视力相比差异有统计学意义;4例诉有眩光,3眼瞳孔轻度变形,2眼术后2d切口渗漏,无视网膜脱离、晶状体脱落或跟内炎等。结论虹膜固定型有晶状体眼人工晶状体植入术治疗高度近视安全、有效,具有良好的预测性。     

高度近视行虹膜固定型人工晶状体植入术的像差变化

目的：探讨有晶体眼虹膜固定型人工晶状体（ IOL）植入术矫正高度近视的安全性、有效性及手术前后像差变化规律。方法对高度近视26例（51眼）行有晶体眼虹膜固定型人工晶状体植入手术,观察术前、术后3个月裸眼视力（ UC-VA）、最佳矫正视力（BCVA）、角膜内皮细胞计数（CECd）、眼压（IOP）、角膜曲率（CC）,利用视觉功能分析仪（iTrace）观察术前、术后1周、术后3个月5 mm瞳孔直径下的总像差、总高阶像差、总低阶像差、球差、慧差、三叶草差的均方根（ RMS）值。术前术后各指标变化比较采用配对t检验。结果①51眼均一次性成功植入虹膜固定型人工晶状体。术后UCVA与术前BC-VA比较差异有统计学意义（P＜0．05）。术后IOP、CECd、CC与术前相比差异无统计学意义（P＞0．05）。②术后1周时,总像差、总低阶像差RMS值与术前比较差异有统计学意义（P＜0．01）,总高阶像差与术前比较差异无统计学意义（P＞0．05）。术后3个月时,总像差、总低阶像差的RMS值与术前比较差异有统计学意义（P＜0．01）,总高阶像差与术前比较差异无统计学意义（ P＞0．05）。从术前至术后3个月,总像差、低阶像差RMS值呈持续降低趋势,高阶像差RMS值呈现先升高后降低的趋势。③术后1周时,球差、慧差的RMS值与术前比较差异有统计学意义（P＜0．05）,三叶草差RMS值与术前比较差异无统计学意义（P＞0．05）。术后3个月时,慧差、球差、三叶草差RMS值与术前比较差异无统计学意义（P＞0．05）。从术前至术后3个月,慧差、球差、三叶草差RMS值呈现先升高后降低趋势。结论有晶体眼虹膜固定型人工晶状体植入术矫正高度近视具有安全、有效、可预测特点。术后3个月内总像差及低阶像差RMS值持续降低,高阶像差、球差、慧差、三叶草差RMS值均呈先增高后降低?     

Retinal Imaging through Phakic Iris-Claw IOL

Abstract

Background: Phakic anterior chamber iris-fixated IOL (PIOL) are established for the correction of high myopia. These patients require attention to macular pathologies. This study was to evaluate the quality of imaging through the PIOLs. Methods: 54 eyes of 31 myopic and hyperopic patients with Verisyse®, Verisyse toric®, and Veriflex® phakic iris-fixated IOL were included. Mean preoperative refraction was ?11.0?D and +5.7?D, respectively; mean follow-up time was 7.4 years (5–11 years). A matched control group was formed without PIOL implantation. OCT scans were performed and evaluated qualitatively and quantitatively. Results: In 52 eyes of 31 patients (96%), a 3D-OCT image and fundus photo could be obtained in good quality. Foveal thickness was significantly thicker in the myopic patients, whereas all other sectors and total volume had no significant difference. Conclusions: It proved possible to obtain high-resolution scans and digital photos of the same quality as without additional phakic IOL.     

有晶状体眼虹膜固定型人工晶状体植入术后房角宽度的改变

目的 使用光学相干断层扫描(optical coherence tomography,OCT)评估有晶状体眼虹膜固定型人工晶状体(intraocular lens,IOL)近视患者植入术后患者房角宽度的变化.方法 28眼(14例)近视患者植入虹膜固定型IOL矫正高度近视.观察术前、术后患者的等效球镜、角膜内皮细胞计数、眼压以及2点、3点、4点、8点、9点、10点钟位的房角宽度.结果 术前、术后等效球镜分别为(-12.95±0.77)D、(-0.35±0.08)D,差异有显著统计学意义(P＜O.001).术前、术后角膜内皮细胞计数分别为(2859.38±62.27) mm-2、(2783.92±62.67) mm-2,差异有统计学意义(P =0.012).术前、术后眼压分别为(11.87±0.40)mmHg(1 kPa=7.5 mmHg)、(11.80±0.40) mmHg,差异无统计学意义(P=0.800).术后3个月,3点、9点钟位房角较术前变窄,差异均有统计学意义(均为P＜0.05),其他方位房角宽度术前、术后差异均无统计学意义(均为P＞0.05).结论 植入虹膜固定型IOL后高度近视患者部分房角变窄,术后应对患者前房变化情况进行随访观察.     

虹膜固定型人工晶状体二期植入治疗无晶状体眼的疗效

目的评价二期植入虹膜固定型人工晶状体治疗各种原因导致的无晶状体眼的疗效。方法选取无晶状体眼患者15例(16眼),均植入虹膜固定型人工晶状体,术后观察患者视力、眼压、角膜内皮细胞计数及并发症情况。结果 15例均一次性成功植入虹膜固定型人工晶状体,显微镜观察人工晶状体位于瞳孔中央。术后裸眼视力0.02-0.80,平均0.35,与术前裸眼视力(手动-0.12)比较差异有统计学意义(P<0.001),与术前矫正视力比较差异无统计学意义(P>0.05)。术后6个月角膜内皮细胞平均丢失率为9.87%。仅1例术后发生瞳孔区玻璃体阻滞。手术前后眼压差异无统计学意义(P>0.05)。结论实施虹膜固定型人工晶状体二期植入术治疗无晶状体眼,能够安全、有效地提高患者的术后视力,但人工晶状体对角膜内皮、虹膜等组织的长期影响还需进一步观察。     

Comparison of iris-fixated foldable lens and scleral-fixated foldable lens implantation in eyes with insufficient capsular support

AIM: To compare the outcomes of vision using two different intraocular lens (IOL) replacement techniques, iris-fixated foldable intraocular lens (IF-IOL) and scleral-fixated foldable intraocular lens (SF-IOL) in patients with insufficient capsular support. METHODS: Total 63 eyes (62 patients) with insufficient posterior capsule support underwent replacement of IF-IOL or SF-IOL between January 2008 and August 2011. Outcome measures included changes in visual acuity, slit lamp examination, refractive indices and corneal curvatures. RESULTS: The mean improvement of uncorrected visual acuity (UCVA) was greater in IF-IOL group compared to the SF-IOL group (0.43 D±0.19 D vs 0.35 D±0.18 D, P<0.05). Moreover, 12 (38.71%) eyes in IF-IOL group and 4 (12.50%) in SF-IOL group had a higher postoperative UCVA than preoperative best corrected visual acuity (BCVA) while 9 (29.03%) eyes in IF-IOL group and 18 (56.25%) in SF-IOL group had a lower postoperative UCVA than preoperative BCVA. The myopic mean manifest sphere and mean cylinder magnitude were lower in the IF-IOL group than that in the SF-IOL group (-0.47 D±0.58 D vs 0.50 D±0.43 D, P<0.01; 0.84 D±0.53 D vs 1.23 D±0.70 D, P<0.05). No difference of corneal astigmatism and surgically induced astigmatism was found between the two groups. In addition, fewer complications were observed in IF-IOL eyes. CONCLUSION: IF-IOL implantation can give a significant improvement in vision with fewer complications than SF-IOL in patients with insufficient capsular support.     

有晶状体眼Verisyse虹膜夹持型人工晶状体植入矫正超高度近视

目的 探讨有晶状体眼Verisyse虹膜夹持型人工晶状体植入术矫正超高度近视的远期有效性、安全性、稳定性及患者满意度.方法 前瞻性队列研究.选取2005年6月至2012年3月就诊于山西省眼科医院超高度近视患者37例(65眼),年龄17 ～44(27.5±8.0)岁,等效球镜度-9.00～-27.00 D,平均(-18.55±4.19)D,行有晶状体眼Verisyse虹膜夹持型人工晶状体植入术,术后平均随访时间3～62(42.3±16.7)个月.对比观察术前及术后1d、1周、1个月、3个月、6个月、1年、2年、3年、5年患者视觉效果.观察指标包括:视力(UCVA、BCVA、近视力)、屈光度、眼压、前节OCT测量IOL位置、角膜内皮细胞计数、对比敏感度、手术并发症及问卷调查患者满意度.定义安全性指数为术后平均BCVA与术前平均BCVA的比值,有效性指数为术后平均UCVA与术前平均BCVA的比值.不同时间点间差异采用重复测量设计的方差分析进行比较.结果 所有患者在整个术后随访过程中,安全性指数始终＞1.术后1个月和2年时有效性指数＜1,其余时间点均＞1.随访5年内93％患眼实际等效球镜度与预期等效球镜度差值在±1 D以内,84％患眼实际等效球镜度与预期等效球镜度差值在±0.5 D以内.患眼术前近视力为0.9±0.2,眼压为(15.2±2.7)mmHg,术后随访各时间点与术前相比差异无统计学意义.随访5年内角膜内皮细胞计数丢失率平均为3.0％±2.5％(0.07％～9.1％).前节OCT测量Verisvse人工晶状体中心与角膜内皮和晶状体间垂直距离分别为(2.20±0.15)mm(＞2.0 mm)及(0.73±0.08)mm(＞0.5 mm).术后与术前相比各空间频率对比敏感度均明显提高,差异有统计学意义.随访期间2只眼可见Verisyse人工晶状体表面炎性反应物沉积,1只眼瞳孔呈轻度横椭圆形,1例(2眼)因剧烈运动导致IOL半脱位,后经手术复位,＞80％患者人工晶状体夹持处虹膜脱色素.经问卷调查,患者满意度为100％.结论 Verisyse虹膜夹持型人工晶状体植入术矫正超高度近视具有良好的有效性、安全性、可预测性、稳定性及患者满意度,是有效眼内屈光手术之一,但是其更长期的安全性评价有待进一步研究.