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首页> 外文期刊>Journal of refractive surgery >Two-year corneal endothelial cell assessment following INTACS implantation.
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Two-year corneal endothelial cell assessment following INTACS implantation.

机译：INTACS植入后两年的角膜内皮细胞评估。

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PURPOSE: To evaluate the 2-year effects of intrastromal corneal ring segments (INTACS) on the corneal endothelium. METHODS: Non-contact specular microscopy was performed as a subgroup test in a Phase III clinical trial. Endothelial cell images were collected before surgery and at 6, 12, and 24 months after surgery at the central and peripheral (6 and 10 o'clock) regions. Images were recorded and analyzed later by a central reading center. Cell density, coefficient of variation, and percent hexagonal cells were determined. RESULTS: There were no clinically significant changes in the endothelial cell structure at 6, 12, and 24 months (102 eyes). There was a gain of 5 cells/mm2 (6 months) and 3 cells/mm2 (12 months) at the central region of the cornea and a loss of 28 cells/mm2 at 24 months. At the 6 o'clock region of the cornea, there was a loss of 0, 24, and 92 cells/mm2 at 6, 12, and 24 months. At the 10 o'clock region of the cornea, there was a loss of 14, 30, and 94 cells/mm2 at 6, 12, and 24 months. INTACS did not statistically affect the central cell density at 6 and 12 months, however, there was a slight loss centrally at 24 months. At 24 months, all corneal regions had a slight decrease in cell density. In all eyes, mean central and peripheral endothelial cell counts remained above 2495 cells/mm2. Coefficient of variation improved and percent hexagonal cells remained unchanged. CONCLUSION: Endothelial cell density changes at 2 years after INTACS implantation were not clinically significant and endothelial cell remodeling was present.
机译：目的：评估基质内角膜环段（INTACS）对角膜内皮的2年影响。方法：非接触式镜面显微镜作为III期临床试验的亚组测试进行。在手术前以及手术后6、12和24个月在中心和外围（6点和10点）收集内皮细胞图像。图像被记录并在以后由中央阅读中心进行分析。确定细胞密度，变异系数和六角形细胞百分比。结果：在第6、12和24个月（102眼）时，内皮细胞结构没有临床上的显着变化。在角膜的中央区域增加了5个细胞/ mm2（6个月）和3个细胞/ mm2（12个月），在24个月时损失了28个细胞/ mm2。在角膜的6点钟位置，在6、12和24个月时，每平方毫米损失0、24和92个细胞。在角膜的10点位置，在6、12和24个月时，每平方毫米损失14、30和94个细胞。 INTACS在6和12个月时没有统计学上影响中央细胞密度，但是，在24个月时有轻微的中央损失。在24个月时，所有角膜区域的细胞密度均略有下降。在所有眼睛中，平均中央和外周内皮细胞计数均保持在2495个细胞/ mm2以上。变异系数提高，六角形细胞百分比保持不变。结论INTACS植入后2年内皮细胞密度变化无临床意义，并且存在内皮细胞重塑。

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