Article as featured in OSN Super Site
Written by: William B. Trattler, MD
Patients have high visual acuity and satisfaction after enhanced laser vision correction.
An interim analysis of the results of 131 patients who participated in an open-label, multicenter, prospective study demonstrated that wavefront-guided laser vision correction surgery with iris registration and femtosecond ablation provided optimal results. In the study, 97% of patients achieved 20/20 or better uncorrected visual acuity, and nearly 70% of patients achieved 20/16 or better vision at the 3-month mark.
We set out to evaluate the efficacy, safety and predictability of an enhanced laser vision correction surgery consisting of wavefront-guided LASIK with iris registration and femtosecond ablation. The follow-up was at 1 month and 3 months.
We conducted an open-label, multicenter, prospective, non-comparative evaluation of up to 30 patients at seven centers (60 eyes per center) scheduled to undergo primary LASIK with the Advanced CustomVue iLASIK suite with the Visx Star S4 IR excimer laser and IntraLase FS femtosecond laser system (both Abbott Medical Optics).
Other surgeons involved in the study were Charles Reilly, MD, Lackland Air Force Base, San Antonio; Stephen Coleman, MD, Coleman Vision, Albuquerque, N.M.; David Schneider, MD, Midwest Eye Center, Cincinnati; Eric D. Donnenfeld, MD, TLC and Ophthalmic Consultants of Long Island, Darden City, N.Y.; Robert Maloney, MD, Maloney Vision Center, Los Angeles; and Larry Katzen, MD, Miami.
The study included patients with a myopic spherical equivalent refractive error ranging from –0.5 D to –6 D and cylinder up to –3 D. Surgical parameters included a mean preoperative cylinder of 0.565 D (range: 0 D to 2.5 D) and a mean preoperative spherical equivalence of –2.8 D (range: –0.85 D to –5.6 D). Preop and postop refraction, Wave-Scan (AMO), UCVA, best corrected visual acuity and pupillometry were evaluated. The iris capture success rate was 92.5%. All re-treatment information was recorded and compared against historical rates.
The interim analysis of this study demonstrated that the CustomVue iLASIK platform provided excellent outcomes. At 1 month, 54.5% of eyes achieved 20/16 or better UCVA, 93.6% of eyes had 20/20 or better UCVA, and 100% achieved 20/30 UCVA or better. At 3 months, 67.9% of eyes achieved 20/16 or better UCVA, 96.7% of eyes had 20/20 or better UCVA, and 100% achieved 20/25 or better UCVA (Figure 1).
Patients completed a questionnaire preoperatively and at the 1- and 3-month postoperative visits. A majority of patients reported that they were very satisfied with their day and nighttime visual outcomes and their improved low-contrast visual acuity (Figure 2). Patients also noted that they were able to return to normal activities immediately. Finally, 100% of patients reported that they were satisfied with their vision overall.
We have found through this study and through our clinical experience with patients at our practice that the CustomVue iLASIK platform provides excellent visual results, allowing patients to rapidly return to their normal activities. These results match the positive findings that were reported by Dr. Steven Schallhorn in his iLASIK driving simulation study, which found that patients who underwent iLASIK had improved reaction times compared to their reaction times prior to LASIK. This study also supports the recommendation that following laser vision correction, patients should have their vision tested to beyond 20/20.
- Schallhorn SC, Tanzer DJ, Kaupp SE, Brown M, Malady SE. Comparison of night driving performance after wavefront-guided and conventional LASIK for moderate myopia. Ophthalmology. 2009;116(4):702-709.
- Trattler W, Reilly C, Coleman S, et al. Refractive outcomes with advanced wavefront-guided ablation customized LASIK. Paper presented at: American Society of Cataract and Refractive Surgery meeting; March 26, 2011; San Diego, CA.