Steinberg Johannes, Mehlan Juliane, Mudarisov Bulat, Katz Toam, Frings Andreas, Druchkiv Vasyl, J Linke Stephan
Department of Ophthalmology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Hamburg Vision Clinic, Hamburg, Germany.
J Ophthalmic Vis Res. 2023 Feb 21;18(1):3-14. doi: 10.18502/jovr.v18i1.12720. eCollection 2023 Jan-Mar.
Currently, two major principles exist to create LASIK flaps: firstly, a strictly horizontal (2D) cut similar to the microkeratome-cut and secondly an angled cut with a "step-like" edge (3D). The strictly horizontal (2D) cut method can be performed using apparatus such as the low-energy FEMTO LDV Z8 laser and its predecessors which are specific to this type. Alternatively, the low-energy FEMTO LDV Z8 laser's 3D flap design creates an interlocking flap-interface surface which potentially contributes toward flap stability. In addition, the FEMTO LDV Z8 offers flap-position adjustments after docking (before flap-creation). The current study analyzed precision, safety, efficacy, as well as patient self-reported pain and comfort levels after applying two different types of LASIK flap morphologies which were created with a low-energy, high-frequency femtosecond (fs) laser device.
A prospective, interventional, randomized, contralateral eye, single-center comparison study was conducted from November 2019 to March 2020 at the Hamburg vision clinic/ zentrumsehstärke, Hamburg, Germany. Eleven patients and 22 eyes received low-energy fs LASIK treatment for myopia or myopic astigmatism in both eyes. Before the treatment, the eyes were randomized (one eye was treated with the 2D, the other eye with the 3D method).
The mean central flap thickness one month after surgery was 110.7 1.6 μm (2D) and 111.2 1.7 μm (3D); = 0.365 (2D vs 3D). Flap thickness measured at 13 different points resulted in no statistically significant differences between any of the measurement points within/between both groups; demonstrating good planarity of the flap was achieved using both methods. Despite not being statistically significant, the surgeons recognized an increase in the presence of an opaque bubble layer in the 3D flap eyes during surgery and some patients reported higher, yet not statistically significant, pain scores in the 3D flap eyes during the first hours after the treatment. Overall, safety- and efficacy indices were 1.03 and 1.03, respectively.
In this prospective, randomized, contralateral eye study, the low-energy fs laser yielded predictable lamellar flap thicknesses and geometry at one-month follow-up. Based on these results, efficacy and safety of the corresponding laser application, that is, 2D vs 3D, are equivalent.
目前，制作准分子激光原位角膜磨镶术（LASIK）瓣存在两大主要原则：其一，进行类似于微型角膜刀切割的严格水平（二维）切割；其二，进行带有“阶梯状”边缘的倾斜切割（三维）。严格水平（二维）切割方法可使用低能量飞秒激光二极管垂直扫描（FEMTO LDV Z8）激光及其同类特定设备来执行。另外，低能量飞秒激光二极管垂直扫描（FEMTO LDV Z8）激光的三维瓣设计可创建一个相互锁定的瓣界面表面，这可能有助于瓣的稳定性。此外，飞秒激光二极管垂直扫描（FEMTO LDV Z8）激光在对接后（瓣制作前）可进行瓣位置调整。本研究分析了使用低能量、高频飞秒（fs）激光设备制作的两种不同类型的LASIK瓣形态应用后的精度、安全性、有效性，以及患者自我报告的疼痛和舒适度水平。
2019年11月至2020年3月，在德国汉堡视觉诊所/zentrumsehstärke进行了一项前瞻性、干预性、随机、对侧眼、单中心比较研究。11名患者的22只眼睛接受了双眼低能量fs LASIK治疗近视或近视散光。治疗前，将眼睛随机分组（一只眼睛采用二维方法治疗，另一只眼睛采用三维方法治疗）。
术后1个月，中央瓣平均厚度二维组为110.7 ± 1.6μm，三维组为111.2 ± 1.7μm；P = 0.365（二维组与三维组）。在13个不同点测量的瓣厚度在两组内/组间的任何测量点之间均无统计学显著差异；表明两种方法均实现了瓣的良好平面度。尽管无统计学显著性，但手术医生在手术过程中发现三维瓣眼睛中不透明气泡层的出现有所增加，并且一些患者报告在治疗后的最初几个小时内，三维瓣眼睛的疼痛评分更高，但无统计学显著性。总体而言，安全性和有效性指数分别为1.03和1.03。
在这项前瞻性、随机、对侧眼研究中，低能量fs激光在1个月随访时产生了可预测的板层瓣厚度和几何形状。基于这些结果，相应激光应用（即二维与三维）的有效性和安全性是等效的。
