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Refractive Outcomes with Advanced Wavefront-Guided LASIK. William Trattler, MD Charles Reilly, MD Consultant to the USAF SG for Refractive Surgery Lackland AFB TX Stephen Coleman, MD Coleman Vision Albuquerque, NM David Schneider, MD Mid West Eye Center Cincinnati, OH
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Refractive Outcomes with Advanced Wavefront-Guided LASIK William Trattler, MD Charles Reilly, MD Consultant to the USAF SG for Refractive Surgery Lackland AFB TX Stephen Coleman, MD Coleman Vision Albuquerque, NM David Schneider, MD Mid West Eye Center Cincinnati, OH Eric Donnenfeld, MD TLC , OCLI Darden City, NY Robert Maloney, MD Maloney Vision Los Angeles CA Larry Katzen, MD Miami, FL
Financial Disclosure • William Trattler, MD is a consultant, has received research support, and is on the speaker’s bureau for Abbott Medical Optics (AMO) • Charles Reilly, MD has no relevant disclosures • Steven Coleman is a consultant for AMO • David Schneider, MD has received funding from AMO for this study • Eric Donnenfeld, MD is a consultant for AMO, Alcon, and Bausch and Lomb • Robert Maloney, MD is a consultant for AMO & Calhoun Vision; Shareholder for Calhoun Vision • Larry Katzen, MD has received funding from AMO for this study
Purpose and Methods • Purpose: • To evaluate the efficacy, safety, and predictability of an enhanced laser vision correction surgery (wavefront-guided, iris registration, and femtosecond ablation) on patients undergoing LASIK surgery. • Open-label, multicenter, prospective, non-comparative evaluation of up to 20 patients/center (40 eyes/center) scheduled to undergo primary LASIK with the Advanced CustomVue iLASIK (Advanced Medical Optics). • Follow-up was at 1 and 3 months. • Myopia must be within -0.5 to -6.0 D, cylinder up to -3 D, and MRSE of -6D. • Pre- and post-op refraction, wavescan, UCVA, BCVA, and pupilometry will be evaluated. • All re-treatment information will be recorded and compared against historical rates. • Interim analysis of 131 patients
Preoperative & Intraoperative Parameters • Mean preoperative cylinder: • 0.565 D (range: 0 to 2.5D) • Mean preoperative spherical equivalence: • -2.80 D (range: -0.85 to -5.60) • Iris capture success rate • 92.5%
UCVA % of Eyes
Low Contrast Visual Acuity Post-Op % of Patients
Patient Were Satisfied with Their Vision Without Lenses/Glasses % of Patients Four point scale: 4= Very Satisfied and 1=Very Dissatisfied.
Conclusions • In this interim analysis, the CustomVue iLASIK platform provided optimal outcomes. • 65.9% of eyes had better than 20/20 UCVA at 3 months • 96.7% of eyes had 20/20 UCVA at 3 months • 100% achieved 20/25 UCVA or better at 3 months • No patients have required enhancements to date. • Patients were very satisfied with their visual outcomes. • Improved low contrast visual acuity • Patients were able to return to normal activities immediately. • 100% of patients were satisfied with their vision