Thomas Bettina C, Fitting Anna, Khoramnia Ramin, Rabsilber Tanja M, Auffarth Gerd U, Holzer Mike P
International Vision Correction Research Centre (IVCRC) and David J Apple International Laboratory of Ophthalmic Pathology, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.
Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.
BACKGROUND/AIMS: To analyse visual outcomes and corneal changes 3 years after intrastromal femtosecond laser presbyopia treatment.
In a prospective, unicentric clinical trial, 25 presbyopic patients received INTRACOR treatment (Technolas femtosecond laser) on their non-dominant eye. Examinations were performed preoperatively as well as 1, 24 and 36 months postoperatively and included refraction, near, intermediate and distance visual acuity tests, reading speed, corneal topography, stray light measurement, endothelial cell count and slit-lamp examination.
Comparison of preoperative versus 36 months postoperative values showed in median an improvement of uncorrected near visual acuity (UNVA) from 0.70 logMAR to 0.10 logMAR (p<0.001). Corrected distance visual acuity (CDVA) was reduced from -0.10 logMAR to 0.00 logMAR (p<0.001). The spherical equivalent preoperatively was 0.625 D and after an initial myopic shift after 1 month (0.125 D) and 24 months (0.25 D), the 36 months value (0.50 D) returned to resemble the preoperative value in statistical terms (p=0.123). A significant corneal steepening of 1.50 D in the treated area was measured. Pachymetry (thinnest point) revealed a statistically significant, but clinically insignificant corneal thickening from 535 to 549 µm (p=0.033). Endothelial cell count did not change. 92.86% of patients felt comfortable with the surgery result.
INTRACOR treatment after 36 months improved UNVA to varying degrees. The effect can be explained by a corneal steepening. An initial myopic shift was reversible. Reductions especially in CDVA have to be taken into account and therefore careful patient selection and information is obligatory.
NCT01164358 and NCT01025050, Results.
背景/目的:分析基质内飞秒激光老视治疗3年后的视力结果和角膜变化。
在一项前瞻性单中心临床试验中,25例老视患者非主导眼接受了INTRACOR治疗(Technolas飞秒激光)。术前以及术后1、24和36个月进行检查,包括验光、近、中、远视力测试、阅读速度、角膜地形图、散射光测量、内皮细胞计数和裂隙灯检查。
术前与术后36个月数值比较显示,未矫正近视力(UNVA)中位数从0.70 logMAR提高到0.10 logMAR(p<0.001)。矫正远视力(CDVA)从-0.10 logMAR降至0.00 logMAR(p<0.001)。术前等效球镜为0.625 D,在术后1个月出现初始近视偏移(0.125 D)和24个月(0.25 D)后,36个月时的值(0.50 D)在统计学上恢复到接近术前值(p=0.123)。测量发现治疗区域角膜显著变陡1.50 D。角膜厚度测量(最薄点)显示角膜厚度从535 µm增至549 µm,具有统计学意义,但临床意义不显著(p=0.033)。内皮细胞计数未改变。92.86%的患者对手术结果感到满意。
36个月后的INTRACOR治疗不同程度地改善了UNVA。这种效果可通过角膜变陡来解释。初始近视偏移是可逆的。必须考虑尤其是CDVA的降低,因此仔细的患者选择和告知是必要的。
NCT01164358和NCT01025050,结果