An advanced LASIK procedure that uses an excimer laser and femtosecond laser (CustomVue iLASIK, Abbott Medical Optics) is safe and effective, and it provides excellent refractive outcomes, based on 1-month results of an ongoing, multicenter, prospective, non-comparative evaluation of 20 patients.
Dr. Coleman is conducting an open-label, multicenter, prospective, non-comparative evaluation of 20 patients scheduled to undergo primary LASIK with the excimer and femtosecond lasers. The goal of the study is to evaluate the efficacy, safety, and predictability of the advanced procedure.
"The excimer laser and femtosecond laser platform resulted in accurate treatment of postoperative sphere and cylinder," he said. "At the 1-month postoperative follow-up, all of the patients (100%) had UCVA of 20/30 or better. More than 97% of the patients (97.4%) had UCVA of 20/25 or better, 94.7% had UCVA of 20/20 or better, and 55.6% had UCVA of 20/16 or better (Figure 1).
According to AMO, its proprietary LASIK procedure enables the broadest range of wavefront-guided approvals, with a high level of precision and accuracy. The procedure leverages iris registration, Fourier algorithms, and proprietary scanning (VSS [variable spot scanning] Refractive) and repetition rate (VRR [variable repetition rate]) technologies to ensure precise ablation, the company said.
In his study, 20 patients (40 eyes) had the excimer laser and femtosecond laser procedure performed. The mean patient age was 29.0 years (range, 23 to 35 years). Thirteen of the patients were male, and 11 were Caucasian.
To be included, the patients' myopia had to be within –0.5 to –6.0 D, cylinder up to –3 D, and mean refractive spherical equivalent of up to –6 D.
The target manifest spheroequivalent refractive error (MSRE) was 0.237. At 1 month postoperatively, mean MSRE in the 20 patients was 0.178. Target cylinder was 0 D; at 1 month, mean cylinder in these patients was –0.306 D.
In addition to the excellent UCVA results, low contrast visual acuity at 1 month was 20/40 or better in 100% of the patients, 20/30 or better in 52.4%, 20/25 or better in 47.6%, and 20/20 or better in 7.1% (Figure 2).
All of the patients (100%) reported being "very satisfied" with their vision during the day without contact lenses or glasses; 72% said they were "very satisfied" with their vision at night without corrective lenses, and 28% said they were "satisfied," Dr. Coleman said (Figure 3).
In addition, all of the patients (100%) said their vision was significantly improved after surgery without glasses compared with before surgery with glasses, and 100% said they were able to return to their normal daily activities the day after the LASIK procedure, he added.
No enhancement procedures were performed.
"Patients were very satisfied with their visual outcomes at 1 month after the excimer laser and femtosecond laser procedure," Dr. Coleman said. "All 20 patients were satisfied with their vision at mesopic and photopic conditions, and all 20 felt that their vision was significantly improved."
He said this study has implications that bode well for the trend of younger patients choosing to undergo LASIK rather than wear corrective lenses.
"The greatest trend currently in laser vision correction is that the average age and pre-op prescription of our typical patient have both decreased dramatically," Dr. Coleman said. "This is much different from 10 years ago, for instance, when prescriptions tended to be quite high. I really consider 'X' and 'Y' generation patients with reasonable prescriptions to be the ideal candidates now. As this study demonstrates, it is unusual to have an outcome that is not 20/20 or better in this population group, and they are uniformly very satisfied with their new vision."