Olson R, Cameron R, Hovis T, Hunkeler J, Lindstrom R, Steinert R
J Cataract Refract Surg. 1997 Nov;23(9):1384-9. doi: 10.1016/s0886-3350(97)80119-8.
To evaluate the clinical acceptability of the Unfolder for implantation of AMO PhacoFlex II (model SI-30NB or SI-40NB) intraocular lenses (IOLs).
Six investigational sites in five states in the United States: Utah, Texas, Missouri, Minnesota, and Massachusetts.
One hundred one patients from six investigational sites had implantation of an SI-30NB or SI-40NB IOL. Investigators evaluated the clinical acceptability of the Unfolder by comparing their experience with the injector with that using other implantation systems. Internal incision size (dimensions) was measured three times during surgery using a calibrated instrument. Data on safety and efficacy were collected.
The investigators rated the Unfolder as clinically acceptable. Mean internal incision size after phacoemulsification but before IOL implantation was 3.0 mm +/- 0.1 (SD) (range 2.7 to 3.2 mm). Average internal incision size after IOL implantation was 3.1 +/- 0.1 mm. There were no reports of haptic deformation, lens optic damage, or postoperative complications related to the Unfolder. No adverse events were reported.
Investigators found the Unfolder easy to use. It provided controlled lens implantation through incisions 2.7 to 3.2 mm, with post-IOL implantation incisions ranging from 2.9 to 3.3 mm.
评估用于植入AMO PhacoFlex II（型号SI - 30NB或SI - 40NB）人工晶状体（IOL）的Unfolder的临床可接受性。
美国五个州的六个研究地点：犹他州、得克萨斯州、密苏里州、明尼苏达州和马萨诸塞州。
来自六个研究地点的101名患者植入了SI - 30NB或SI - 40NB人工晶状体。研究者通过将使用该注射器的经验与使用其他植入系统的经验进行比较，评估了Unfolder的临床可接受性。在手术过程中使用校准仪器三次测量内切口尺寸（大小）。收集了关于安全性和有效性的数据。
研究者将Unfolder评定为临床可接受。超声乳化术后但人工晶状体植入前的平均内切口尺寸为3.0毫米±0.1（标准差）（范围2.7至3.2毫米）。人工晶状体植入后的平均内切口尺寸为3.1±0.1毫米。没有关于襻变形、晶状体光学部损伤或与Unfolder相关的术后并发症的报告。未报告不良事件。
研究者发现Unfolder易于使用。它通过2.7至3.2毫米的切口实现了可控的晶状体植入，人工晶状体植入后的切口范围为2.9至3.3毫米。
