Comparison of Femto-LASIK With Combined Accelerated Cross-linking to Femto-LASIK in High Myopic Eyes: A Prospective Randomized Trial.

PURPOSE: To evaluate the safety and efficacy of femtosecond (fs) laser-assisted in situ keratomileusis (LASIK) combined with accelerated corneal cross-linking (LASIK Xtra) compared to conventional fs-LASIK (convLASIK) in high myopic patients.

DESIGN

Prospective, randomized, fellow-eye controlled clinical trial.

METHODS

Setting

Department of Ophthalmology, Goethe University, Frankfurt/Germany. StudyPopulation: Twenty-six patients with high myopia and/or myopic astigmatism received randomized treatment with LASIK Xtra (30 mW/cm2, 90 seconds with continuous ultraviolet-A) in 1 eye and convLASIK in the other eye. MainOutcomeMeasures: Uncorrected distance visual acuity (UDVA), best spectacle-corrected VA (BSCVA), manifest refractive spherical equivalent (MRSE), endothelial cell count (ECC), and corneal thickness.

RESULTS

The UDVA improved from 1.26 ± 0.13 logMAR preoperative to -0.02 ± 0.15logMAR in LASIK Xtra eyes and from 1.27 ± 0.12 logMAR to 0.01 ± 0.15 logMAR in the convLASIK eyes (P > .05). The MRSE changed from -7.35 ± 1.15 diopters (D) and -7.5 ± 1.12 D to -0.17 ± 0.43 D and -0.25 ± 0.46 D, respectively. There was no significant difference in outcomes between both groups during the 12 months follow-up except for the convLASIK eyes' showing slightly better BSCVA after 1 week (P < .05). ConvLASIK eyes revealed a nonsignificant trend toward myopic regression from 3 to 12 months postoperative with a change in MRSE of -0.15 D compared to -0.1 D in LASIK Xtra eyes. Topography showed stability of corneal curvature with no signs of keratectasia in both groups at 12 months.

CONCLUSION

While apparently safe, LASIK Xtra showed no advantages over conventional LASIK. At 12 months, both groups showed no difference regarding UDVA and refractive stability, and no signs of keratectasia.