Martin R G, Sanders D R, Van der Karr M A, DeLuca M
Medical Care International Research and Training Institute, Southern Pines, North Carolina 28387.
J Cataract Refract Surg. 1992 Jan;18(1):51-7. doi: 10.1016/s0886-3350(13)80383-5.
A single center, single surgeon, randomized, prospective clinical trial was performed comparing the effectiveness of small (3.5 mm to 4.0 mm) incision intraocular lens surgery and a larger (6.0 mm) incision in improving uncorrected visual acuity and reducing post-operative inflammation and surgically induced astigmatism. One hundred twelve eligible unilateral cases were randomized to receive a 3.5 mm to 4.0 mm incision with implantation of an Allergan Medical Optics three-piece SI-18NB silicone lens (56 cases) or a 6.0 mm incision with implantation of a three-piece biconvex poly(methyl methacrylate) lens (56 cases). At one day after surgery, significantly (P less than .01) more patients with 3.5 mm incisions had 20/40 or better uncorrected visual acuity than patients with 6.0 mm incisions (45% vs 20%). Forty percent of patients with 6.0 mm incisions vs 14% of patients with 3.5 mm incisions had visual acuities of 20/100 or worse. At one day after surgery, the larger incision group had significantly higher (P less than .01) mean keratometric cylinder (2.28 diopters vs 1.28 diopters in the small incision group). The two groups were comparable by three months. Laser flare/cell meter measurements were taken for each group but showed no significant differences in mean flare or cell measurements between the groups.
开展了一项单中心、单术者的随机前瞻性临床试验，比较小切口（3.5毫米至4.0毫米）人工晶状体手术与较大切口（6.0毫米）在改善裸眼视力、减轻术后炎症和手术诱导散光方面的有效性。112例符合条件的单侧病例被随机分为两组，一组接受3.5毫米至4.0毫米切口并植入爱尔康医疗光学公司的三件式SI-18NB硅胶晶状体（56例），另一组接受6.0毫米切口并植入三件式双凸聚甲基丙烯酸甲酯晶状体（56例）。术后一天，3.5毫米切口组裸眼视力达到20/40或更好的患者显著多于6.0毫米切口组（P小于0.01）（45%对20%）。6.0毫米切口组40%的患者与3.5毫米切口组14%的患者视力为20/100或更差。术后一天，较大切口组的平均角膜散光显著更高（P小于0.01）（2.28屈光度对小切口组的1.28屈光度）。两组在三个月时具有可比性。对每组进行了激光闪光/细胞测量，但两组之间的平均闪光或细胞测量结果无显著差异。
