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First Author: M.Mita JAPAN
Co Author(s): M. Tomita
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Aiming to prevent regression and/or keratoectasia, LASIK Xtra (Accelerated Collagen Crosslinking (CXL) using the KXL System from Avedro, Inc along with LASIK) is now being performed. In this high volume study, we performed LASIK Xtra to treat highly myopic patients (preoperative manifest reaction spherical equivalent of -6.00D to -11.88 D) and evaluated the results and safety.
Shinagawa LASIK Center, Tokyo, Japan
A prospective, IRB approved evaluation of LASIK Xtra was performed. The study included 765 eyes of 428 highly myopic patients (age: 18 to 63 years old). Preoperative mean manifest refraction spherical equivalent (MRSE) was -8.08 ±1.50 D (range: -6.00 D to -11.88 D). After Femto LASIK, Accelerated CXL was performed. This included a 90 second riboflavin pre-soak that was applied to the stromal bed after which the riboflavin was rinsed away. After the flap was returned to its original position, 30mW/cm2 of ultraviolet A light was applied for 90 seconds using the KXL System. Visual acuity, manifest refractions, keratometric (K) reading, endothelial cell density (ECD) count, morphological change by confocal microscopy and optical coherence tomography (OCT) were taken and evaluated.
417 eyes of 236 patients returned for their 1 year check-up. Their results follow: The mean preoperative uncorrected distance visual acuity was 1.42 LogMAR which improved to -0.14 postoperatively (P < 0.01). The average preoperative corrected distance visual acuity of was -0.15 LogMAR, which improved to -0.18 postoperatively (P < 0.01). MRSE was?-0.07?ḟ?0.48 D at 1 year ?P < 0.01?.?We evaluated the 1 Week and 1 Year postoperative MRSE and found that there was no statistical significant difference (P > 0.05) between them. The K reading was 43.78 ±1.37 D preoperatively, 37.46 ±1.65 D at 1 month, and 37.59 ±1.59 D at 1 year postoperative. No intra or postoperative complications due to CXL were observed. No one received re-treatment.
The safety of post LASIK Xtra for patients with high myopia was confirmed through the 1 year follow up. The results including both stable visual acuity and refraction suggest that LASIK Xtra surgery is as safe and effective as regular LASIK. Long term follow-up studies are necessary to confirm this conclusion.