Lifshitz Tova, Levy Jaime, Aizenman Isaac, Klemperer Itamar, Levinger Shmuel
Department of Ophthalmology (Sheva Enaim), Soroka University Medical Center, Ben-Gurion University of the Negev, PO Box 151, Beer-Sheva, 84101, Israel.
Int Ophthalmol. 2004 Jul;25(4):233-8. doi: 10.1007/s10792-005-5016-2. Epub 2005 Sep 29.
To evaluate the safety indexes and efficacy of Artisan phakic intraocular lens (IOL) for the correction of high myopia.
Retrospective interventional case series reports. Thirty-one eyes (22 patients) with myopia from -5.25 to -19.00 diopters underwent implantation of an Artisan phakic IOL. Follow-up examinations were performed at 1 day, 1 week, 1 month, and 3 months. The following parameters were recorded: manifest refraction, slit-lamp examination, applanation tonometry, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), complications or adverse reactions. The primary variable was the refractive outcome at 3 months. Secondary variables were change in BSCVA, and efficacy and safety indexes.
At 3 months, mean spherical equivalent was -0.50 +/- 0.36 diopters (range, -1.25 - plano). In 29 eyes (93.5%) UCVA was 6/12 or better; the other three eyes had UCVA of 6/15. The difference between preoperative and 1 week postoperative BSCVA was not statistically significant (p = 0.25). Comparison of BSCVA at 1 week and at 1 month was statistically significant (p = 0.05); this difference was even more significant at 3 months (p = 0.01). The BSCVA remained the same or improved for all the eyes. BSCVA for 20 eyes (64.5%) had improved one or more lines in visual acuity. Mean endothelial cell loss at 3 months was 3.96%.
The Artisan lens is a safe, predictable, and efficacious method to correct high myopia. Postoperative gain in BSCVA was achieved for the majority of eyes. Future study to assess safety indexes and risk of complications is required with long-term follow-up.
评估Artisan有晶状体眼人工晶状体（IOL）矫正高度近视的安全性指标和有效性。
回顾性干预病例系列报告。31只眼（22例患者）近视度数在-5.25至-19.00屈光度之间，接受了Artisan有晶状体眼IOL植入术。在术后1天、1周、1个月和3个月进行随访检查。记录以下参数：显验光、裂隙灯检查、压平眼压测量、未矫正视力（UCVA）、最佳眼镜矫正视力（BSCVA）、并发症或不良反应。主要变量是3个月时的屈光结果。次要变量是BSCVA的变化以及有效性和安全性指标。
3个月时，平均球镜等效度数为-0.50±0.36屈光度（范围，-1.25 - 平光）。29只眼（93.5%）的UCVA为6/12或更好；另外三只眼的UCVA为6/15。术前和术后1周BSCVA的差异无统计学意义（p = 0.25）。1周和1个月时BSCVA的比较有统计学意义（p = 0.05）；3个月时这种差异更显著（p = 0.01）。所有眼睛的BSCVA保持不变或提高。20只眼（64.5%）的BSCVA视力提高了一行或多行。3个月时平均内皮细胞损失率为3.96%。
Artisan晶状体是矫正高度近视的一种安全、可预测且有效的方法。大多数眼睛术后BSCVA有所提高。需要进行长期随访的未来研究来评估安全性指标和并发症风险。
