Sanders Donald R, Sanders Monica L
Center for Clinical Research, Elmhurst, Illinois 60126, USA.
Ophthalmology. 2007 Sep;114(9):1679-84. doi: 10.1016/j.ophtha.2006.12.017. Epub 2007 Mar 21.
To present the clinical results that demonstrate the efficacy of the Tetraflex accommodative intraocular lens (IOL) in providing both enhanced distance and near acuity.
Single-center prospective data collection performed in Manchester, United Kingdom.
A series of 95 eyes of 59 patients implanted with the Tetraflex lens was performed by a single surgeon. Thirty-six of these cases were implanted bilaterally.
Implantation of the Tetraflex accommodative IOL.
Prospective data collection included both uncorrected distance visual acuity (UCDVA) and uncorrected near visual acuity (UCNVA) testing, manifest refraction, best-corrected distance visual acuity (BCDVA), distance corrected near visual acuity (DCNVA), and the amplitude of accommodation. Intraoperative and postoperative complications also were reported.
At 6 months after surgery, 63% of all cases achieved a DCNVA of 20/40 or better. Virtually all of the patients had at least 1 diopter (D) of accommodative amplitude (98% at 1 month; 100% at 3 and 6 months); 75.7% had at least 2 D at 6 months after surgery. At 6 months or later, 92.2% had 20/40 or better UCDVA. The proportion of cases achieving a UCNVA of 20/40 or better remained relatively constant at 45% to 47%. At 6 months and later, 98.7% had a BCDVA of 20/40 or better. In the bilaterally implanted series, at 1 month after surgery, all patients had at least 1 D of accommodative ability; 96% had at least 2 D at 6 months. One hundred percent achieved a BCDVA, 89.3% achieved a DCNVA, and 74.1% achieved a UCNVA of 20/40 or better at 6 months after surgery.
The Tetraflex accommodating IOL provides enhanced near vision with good distance vision 6 months after surgery.
展示临床结果，以证明Tetraflex可调节人工晶状体（IOL）在提高远视力和近视力方面的有效性。
在英国曼彻斯特进行的单中心前瞻性数据收集。
由一名外科医生为59例患者的95只眼植入了Tetraflex晶状体。其中36例为双侧植入。
植入Tetraflex可调节人工晶状体。
前瞻性数据收集包括未矫正远视力（UCDVA）和未矫正近视力（UCNVA）测试、显然验光、最佳矫正远视力（BCDVA）、远距矫正近视力（DCNVA）以及调节幅度。还报告了术中及术后并发症。
术后6个月时，所有病例中有63%的患者DCNVA达到20/40或更好。几乎所有患者的调节幅度至少为1屈光度（D）（术后1个月时为98%；3个月和6个月时为100%）；术后6个月时，75.7%的患者调节幅度至少为2D。术后6个月或更晚时，92.2%的患者UCDVA达到20/40或更好。UCNVA达到20/40或更好的病例比例相对稳定，为45%至47%。术后6个月及更晚时，98.7%的患者BCDVA达到20/40或更好。在双侧植入组中，术后1个月时，所有患者的调节能力至少为1D；术后6个月时，96%的患者调节幅度至少为2D。术后6个月时，100%的患者BCDVA达标，89.3%的患者DCNVA达标，74.1%的患者UCNVA达到20/40或更好。
Tetraflex可调节人工晶状体在术后6个月时可提高近视力并保持良好的远视力。
