Tetraflax可调节人工晶体与Softecl单焦点人工晶体植入术后早期临床观察

Early clinical investigation between Tetraflex accommodating intraocular lens and Softec Ⅰ monofocal intraocular lens

目的探讨Tetraflax可调节人工晶体与Softec Ⅰ单焦点人工晶体术后的拟调节能力。方法前瞻性对照临床研究,纳入本研究患者共57例(66眼),按植入的晶体分为2组,植入Tetraflex可调节人工晶状体(试验组)29例(33眼);植入Softec Ⅰ单焦点人工晶状体(对照组)28例(33眼)。进行常规白内障检查,随访时间6个月。分别观察视力情况、调节幅度、前房深度变化量以及主观视功能。所得观察值进行统计学分析。结果 Tetraflex组患者的裸眼近视力和最佳矫正远视力下的近视力优于Softec Ⅰ组(P<0.05)。术后6个月应用负镜片法测得的表观调节力:Tetraflex组为(1.50±0.75)D,Softec Ⅰ组为(0.50±0.25)D(P<0.05)。滴20 g/L毛果芸香碱滴眼液后,前房深度变化术后6个月Tetraflex组为(0.50±0.18)mm,Softec Ⅰ组为(0.18±0.10)mm(P<0.05)。Tetraflex组的主观视功能优于对照组。结论与传统的单焦点人工晶状体相比,Tetraflex可调节人工晶状体满足了患者视远、视近的要求,并可提供较好的表观调节力。Tetraflex可调节人工晶状体是安全有效的。

Objective To investigate the accommodating capability between Tetraflex accommodating intraocular lens and Softec I monofocal intraocular lens.Methods Using prospective controlled design,66 eyes of 57 cataract operative cases were assigned to either Tetraflex accommodating intraocular lens group（33 eyes of 29 patients） or Softec I monofocal intraocular lens group（33 eyes of 28 patients）.Postoperative examination included visual function,followed up for six months.Results Statistical results indicated that the UCNVA and DCNVA of the patients in Tetraflex group were better than in Softec I group（P〈0.05）.The minus-lens test suggested that patients in Tetraflex group（1.50±0.75）D had better accommodation pseudophakic eyes than Softec I group（0.50±0.25）D,P〈0.05.After 20 g/L pilocarpine eye drops,patients in Tetraflex group,anterior chamber depth variation,（0.50±0.18） mm,had better subjective visual function than Softec I group,anterior chamber depth variation,（0.18＋0.10） mm,P〈0.05.Conclusion The Tetraflex IOL is safe and effective.Compared with SIOL implanting operation,Tetraflex IOL implanting operation had better distant and near visual acuity,and pseudophakic accommodation.