Department of Ophthalmology, Goethe-University, Frankfurt, Germany.
California Eye Institute, Fresno, California.
Ophthalmology. 2016 May;123(5):1027-35. doi: 10.1016/j.ophtha.2015.12.028. Epub 2016 Feb 11.
To evaluate the 5-year efficacy of a foldable, hydrophobic, angle-supported phakic intraocular lens (pIOL) when used to correct moderate to high myopia.
Prospective, nonrandomized, multicenter, open-label cohort study conducted in the United States, the European Union, and Canada (3 separate protocols).
This was a pooled analysis of 515 eyes from 360 patients 18 to 49 years of age with moderate to high myopia (preoperative corrected distance visual acuity [CDVA] ≤0.34 logarithm of the minimum angle of resolution [logMAR]) and with variance in the manifest refraction spherical equivalent within ±0.5 diopter (D) for a minimum of 12 months.
Implantation of the AcrySof Cachet angle-supported anterior chamber pIOL (Alcon Laboratories, Inc., Fort Worth, TX).
Uncorrected distance visual acuity (UDVA), CDVA, predictability and stability of manifest refraction spherical equivalent (MRSE), serious adverse events, endothelial cell density, and patient satisfaction.
Of 360 patients who received implantation in at least 1 eye (515 eyes), 326 (90.6%) completed the study (5-year best-corrected visual acuity data available for 415 eyes). At 5 years, a decrease in CDVA of 2 lines or more was observed in 0.5% of eyes (n = 2/415) compared with preoperative baseline. At 5 years, all 415 eyes achieved a CDVA of 0.34 logMAR or less; 91.3% (n = 379/415) had a CDVA of 0.04 logMAR or less. Mean UDVA ± standard deviation (SD) was 0.01±0.18 logMAR; 94.7% (n = 393/415) and 66.3% (n = 275/415) of eyes had a UDVA of 0.34 logMAR or less or 0.04 logMAR or less, respectively, at 5 years. Mean MRSE ± SD was -0.34±0.57 D (range,-2.50 to 1.63 D). Most eyes (89.8%; n = 371/413) had an MRSE within ±1.00 D of their target refractive error at 5 years and 67.3% (n = 278/413) were within ±0.50 D. Mean annualized central endothelial cell loss was 1.46% (90% confidence interval [CI], -1.6% to -1.3%) from 6 months to 5 years. The most common pIOL-related serious adverse event was adhesion between the cornea and the iris (synechia; n = 24). Most patients (98.1%) indicated that they would have the same pIOL implanted again.
In patients with moderate to high myopia, the AcrySof Cachet angle-supported pIOL provided excellent refractive correction for up to 5 years after implantation, with a low rate of mean central endothelial cell loss. Careful patient selection is necessary to achieve optimal postsurgical outcomes.
评估一种可折叠、疏水、角支撑型有晶状体眼人工晶状体（pIOL）在矫正中高度近视中的 5 年疗效。
前瞻性、非随机、多中心、开放标签队列研究，在美国、欧盟和加拿大进行（3 个独立方案）。
这是一项汇总分析，共纳入 360 例年龄在 18 至 49 岁的患者的 515 只眼，这些患者患有中高度近视（术前矫正远视力[CDVA]≤0.34 最小角分辨率对数[logMAR]），且在至少 12 个月的时间内表现出等效球镜屈光度（MRSE）的变化范围在±0.5 屈光度（D）以内。
植入 AcrySof Cachet 角支撑前房 pIOL（Alcon Laboratories，Inc.，沃斯堡，TX）。
未矫正远视力（UDVA）、CDVA、MRSE 的可预测性和稳定性、严重不良事件、内皮细胞密度和患者满意度。
在至少一只眼接受植入术的 360 例患者（515 只眼）中，326 例（90.6%）完成了研究（5 年最佳矫正视力数据可用于 415 只眼）。与术前基线相比，5 年后有 0.5%（2/415）的眼出现 CDVA 下降 2 行或以上。5 年后，所有 415 只眼均达到 CDVA 0.34 logMAR 或以下；91.3%（379/415）的眼达到 CDVA 0.04 logMAR 或以下。平均 UDVA±标准差（SD）为 0.01±0.18 logMAR；94.7%（393/415）和 66.3%（275/415）的眼在 5 年后的 UDVA 分别为 0.34 logMAR 或以下或 0.04 logMAR 或以下。平均 MRSE±SD 为-0.34±0.57 D（范围，-2.50 至 1.63 D）。大多数眼（89.8%；371/413）在 5 年内的 MRSE 与其目标屈光误差相差±1.00 D，67.3%（278/413）的眼相差±0.50 D。从 6 个月到 5 年，平均每年中央内皮细胞丢失率为 1.46%（90%置信区间[CI]，-1.6%至-1.3%）。最常见的 pIOL 相关严重不良事件是角膜和虹膜之间的粘连（虹膜睫状体炎；24 例）。大多数患者（98.1%）表示他们会再次植入相同的 pIOL。
在中高度近视患者中，AcrySof Cachet 角支撑型 pIOL 在植入后长达 5 年内提供了出色的屈光矫正效果，中央内皮细胞丢失率较低。需要仔细选择患者以实现最佳术后效果。
