Safety and Precision of Two Different Flap-morphologies Created During Low Energy Femtosecond Laser-assisted LASIK.

Purpose: 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. Methods: 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). Results: The mean central flap thickness one month after surgery was 110.7 ± 1.6 µm (2D) and 111.2 ± 1.7 µm (3D); P = 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. Conclusion: 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.

Comparison of Laser In Situ Keratomileusis Flap Morphology and Predictability by WaveLight FS200 Femtosecond Laser and Moria Microkeratome: An Anterior Segment Optical Coherence Tomography Study.

PURPOSE: To evaluate laser in situ keratomileusis (LASIK) flap thickness predictability and morphology by femtosecond (FS) laser and microkeratome (MK) using anterior segment optical coherence tomography. METHODS: Fifty-two candidates for the LASIK procedure were stratified into two groups: FS laser-assisted (Allegretto FS-200) and MK flap creation (Moria 2). Flap thickness was determined at five points. The side-cut angle was measured in three directions at the margin interface. LASIK flap assessment was performed one month postoperatively by Spectralis anterior segment optical coherence tomography. RESULTS: Fifty-two patients (93 eyes) were recruited; 49 eyes were stratified to the FS group and 44 eyes to the MK group. The FS group had relatively even flap configurations, and the MK group had meniscus-shaped flaps. Mean differences between planned and actual flap thickness were 12.93 ± 8.89 and 19.91 ± 5.77 µm in the FS and MK groups, respectively. In thin flaps (100 to 110 µm), there was a significant disparity between the two groups (7.80 ± 4.71 and 19.44 ± 4.46 µm in the FS and MK groups, respectively). However, in thicker flaps (130 µm), comparable flap thickness disparity was achieved (18.54 ± 9.52 and 20.83 ± 5.99 µm in the FS and MK groups, respectively). Mean side-cut angle was 74.29 ± 5.79 degrees and 32.34 ± 4.94 degrees in the FS and MK groups, respectively. CONCLUSIONS: Comparable flap thickness predictability was achieved in thicker flaps (130 µm), while the FS laser technique yielded a more predictable result in thinner flaps (100 to 110 µm). Different flap morphology was observed in meniscus flaps in MK-LASIK and flap morphology in FS-LASIK.

Comparative Analysis of LASIK Flap Diameter and its Centration Using Two Different Femtosecond Lasers.

The aim of this study was to compare the diameter, accuracy, variability, and centration with respect to the limbus of corneal flaps created by two femtosecond lasers, the VisuMax, and Wavelight FS200, for laser in situ keratomileusis (LASIK) and how these flaps affect visual outcomes. This is a retrospective chart review of flap morphology created during LASIK Surgery. Overall, 168 eyes underwent flap creation using the WaveLight FS200 laser, and on 189 eyes, the VisuMax laser was used. Of these total number, flap morphology was analyzed in a random sample of 158 eyes; 80 with the Visumax laser and 78 with the WaveLight FS200 laser. Intraoperative photos of the flaps taken by the Wavelight Allegretto EX500 were analyzed. Flap diameters and centration were measured using Adobe Acrobat Pro. All patients had visual acuity measurements including uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent refraction (SE) and refractive astigmatism recorded three months postoperatively. Greater than 90% of patients in both groups achieved a UDVA of 20/20 postoperatively. The mean difference between targeted and achieved flap diameter was 0.50 +/- 0.15 mm in the VisuMax group and 0.35 +/- 0.15 millimeters (mm) in the FS200 group (P<0.01). The flap diameters of the VisuMax group were more precise with a variance of 0.024 mm compared to a variance of 0.038 mm in the FS200 group (P<0.05). VisuMax flaps were more nasally displaced (log(NA/TA) = -0.21 +/- 0.10 mm) compared to the FS200 flaps (log(NA/TA) = 0.03 +/- 0.10 mm), (P< 0.01). We concluded that both the VisuMax and FS200 created flaps larger than the preoperative targeted diameter. VisuMax created corneal flaps that had a greater degree of deviation from the targeted diameter when compared to flaps from the FS200. However, there was less variance in the VisuMax flap diameter. In addition, VisuMax flaps were more nasally displaced. There were no statistically significant differences in visual outcomes when comparing the two femtosecond lasers.