Buehl Wolf, Menapace Rupert, Findl Oliver, Neumayer Thomas, Bolz Matthias, Prinz Ana
Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
Am J Ophthalmol. 2007 Jun;143(6):913-919. doi: 10.1016/j.ajo.2007.02.017. Epub 2007 Apr 2.
To compare the posterior capsule opacification (PCO) inhibiting effect of the round anterior and sharp posterior optic edge profile of the Clariflex silicone intraocular lens (IOL) [AMO Inc, Santa Ana, California, USA] with that of the double-round edge profile of the SI40 (Phacoflex; AMO Inc, Santa Ana, California, USA) silicone IOL over a period of three years.
Prospective, randomized, double-masked, bilateral clinical trial.
The study took place at the Department of Ophthalmology, Medical University of Vienna, Austria. Fifty-two patients with age-related cataracts (104 eyes) were included in the study. Each patient received an SI40 IOL (round edges) in one eye and a Clariflex IOL with OptiEdge (sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, and one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was subjectively assessed with the slit-lamp and objectively assessed by automated image analysis software (the computer program Automated Quantification of After-Cataract [AQUA]; Vienna, Austria) one, two, and three years after surgery.
The Clariflex lens showed markedly less PCO at one, two, and three years after surgery. The mean AQUA PCO score was 1.39 for the SI40 and 0.56 for the Clariflex lens after one year, estimated at 1.64 and 0.57 after two years, and at 2.04 and 0.64, respectively, after three years (scale zero to 10; P < .001). The Nd:YAG laser capsulotomy rate was far higher in the SI40 group (Five cases vs one case at three years).
The sharp posterior optic edge profile of the Clariflex silicone IOL led to marked and consistently less PCO than the round-edged SI40 IOL one, two, and three years after surgery.
比较美国加利福尼亚州圣安娜市AMO公司生产的Clariflex硅酮人工晶状体(IOL)的圆形前光学边缘和尖锐后光学边缘轮廓与SI40(Phacoflex;美国加利福尼亚州圣安娜市AMO公司)硅酮IOL的双圆形边缘轮廓在三年时间内对后囊膜混浊(PCO)的抑制效果。
前瞻性、随机、双盲、双侧临床试验。
该研究在奥地利维也纳医科大学眼科进行。52例年龄相关性白内障患者(104只眼)纳入研究。每位患者一只眼植入SI40 IOL(圆形边缘),另一只眼植入带有OptiEdge(尖锐后光学边缘)的Clariflex IOL。随访检查时间点为术后1周、1个月、6个月以及1年、2年和3年。对每只眼拍摄数字后照图像。术后1年、2年和3年,通过裂隙灯主观评估PCO程度,并使用自动图像分析软件(奥地利维也纳的计算机程序“后发性白内障自动定量分析”[AQUA])客观评估PCO程度。
Clariflex晶状体在术后1年、2年和3年时显示出明显更少的PCO。术后1年,SI40的平均AQUA PCO评分为1.39,Clariflex晶状体为0.56;2年后估计分别为1.64和0.57;3年后分别为2.04和0.64(评分范围0至10;P <.001)。SI40组的Nd:YAG激光囊膜切开率远高于Clariflex组(3年时分别为5例和1例)。
与圆形边缘的SI40 IOL相比,Clariflex硅酮IOL的尖锐后光学边缘轮廓在术后1年、2年和3年导致明显且持续更少的PCO。