Tetraflex可调节人工晶状体的早期临床应用研究

Early Clinical Application of Tetraflex Accommodative Intraocular Lens

目的研究Tetraflex可调节人工晶状体(IOL)调节幅度、主观视功能等方面的临床应用效果。方法前瞻性病例对照研究。16例(20眼)入选本研究,行超声乳化白内障摘除联合IOL植入术。7例(10眼)植入Tetraflex可调节IOL(Tetraflex组),9例(10眼)植入AR40e单焦IOL(对照组)。术后检查视力情况、调节幅度(动态视网膜检影法、负镜片法、移进法)、前房深度(anterior chamber depth,ACD)变化及主观视功能。所得的观察值行重复测量的方差分析。结果 Tetraflex组的矫正远视力下的近视力明显好于对照组(P<0.05)。三种调节力测量方法所测得的调节力,Tetraflex组均高于对照组(P<0.001);术后1月ACD变化值分别为(0.44±0.28)mm、(0.26±0.23)mm,术后3月为(0.40±0.24)mm、(0.27±0.25)mm(P>0.05);Tetraflex组的主观视功能优于对照组(P=0.025)。结论 Tetraflex可调节IOL早期可提高矫正远视力下的近视力,增加伪调节力,改善主观视功能。但其远期效果还有待进一步观察。

Objective To investigate the accommodating capability and subjective visual function of the Tetraflex accommodative intraocular lens（IOL）.Methods A prospective case-control study was adopted.Sixteen patients（20 eyes） were selected to undergo phacoemulsifacation and implanted with Tetraflex accommodative IOL（study group,10 eyes） or AR40e monofocal IOL（control group,10 eyes）.Patients were assessed for the visual acuity,the amplitude of accommodation,the change of the anterior chamber depth（ACD） and the subjective visual function after the surgery.Results During the follow-up time,the patients in the study group had better distance corrected near visual acuities（P=0.003）.The accommodative amplitude by three different methods was significantly higher in the study group.The change of the anterior chamber depth（ACD） was not statistically significant between the study group and the control group（P0.05）.In the subjective evaluation of visual function,the study group got higher score than the control group（P0.05）.Conclusion The study shows that the Tetraflex accommodative IOL is significantly better than the monofocal IOL.