Alcon CustomCornea wavefront-guided retreatments after laser in situ keratomileusis

PURPOSE: To evaluate the outcome of wavefront-guided ablations for the correction of residual myopia and astigmatism after standard laser in situ keratomileusis (LASIK). METHODS: Twenty nine eyes of 26 patients who underwent wavefront-guided LASIK retreatment with Alcon CustomCornea (Alcon Laboratories Inc, Fort Worth, Tex) were evaluated. Complete ophthalmologic examination, corneal topography, and wavefront measurements were performed. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, and wavefront analysis were evaluated preoperatively, 1 week, 3 months, and 6 months after surgery. Wavefront measurements were assessed using the LADARWave device. Statistical analysis was performed using the McNemar test and percentages of success. RESULTS: One week postoperatively, UCVA was > or =20/40 in 100% of eyes (> or =20/20 in 31%) and BSCVA was > or =20/40 in 100% (> or =20/20 in 73%). Wavefront analysis showed a decrease in total aberrations, high order aberrations, defocus, coma, spherical aberration, and other terms of higher order aberrations at 1-week follow-up. Three months postoperatively, UCVA was > or =20/40 in 100% of eyes (> or =20/20 in 38%) and BSCVA was > or =20/40 in 100% (> or =20/20 in 81%). Six months postoperatively, UCVA was > or =20/40 in 100% of eyes (> or =20/20 in 60%) and BSCVA was > or =20/40 in 100% (> or =20/20 in 90%). Wavefront analysis showed decrease in total aberration, high order aberration, defocus, coma, and spherical aberration. CONCLUSION: Wavefront-guided LASIK retreatment in post-LASIK eyes represents a good option for laser vision correction. All eyes showed reduction in pre-existing total aberrations. Some high order aberration components decreased in this initial series. Further follow-up is necessary to assess the initial predictability of wavefront-guided LASIK upgrade.     

A comparison of induced astigmatism in conventional and wavefront-guided myopic LASIK using LADARVision4000 and VISX S4 platforms

PURPOSE: To evaluate and compare the surgically induced astigmatism in myopic eyes undergoing conventional and wavefront-guided LASIK. METHODS: A retrospective review was performed of the charts of 200 myopic eyes of 121 patients who underwent either custom or conventional treatments via the VISX S4 or LADARVision4000 platforms (50 consecutive eyes in each of the four groups). The primary outcome measure was manifest refraction, which was evaluated preoperatively and at 3 months postoperatively. The magnitude and axis of the unintended surgically induced astigmatism were calculated using vector analysis. The Student t test was used to compare the magnitudes of the surgically induced astigmatism and the absolute angle of error. RESULTS: The mean preoperative manifest cylinder was 0.66 +/- 0.38 diopters (D) for conventional VISX S4 and 0.68 +/- 0.39 D for VISX CustomVue (P = .795), and 0.76 +/- 0.56 D for LADARVision and 0.61 +/- 0.36 D for LADAR CustomCornea (P = .114). The success index was 0.19 +/- 0.41 for VISX S4 and 0.49 +/- 0.49 for VISX CustomVue (P = .0013), and 0.25 +/- 0.47 for LADARVision and 0.20 +/- 0.39 for LADAR CustomCornea (P = .5721). The absolute mean angle of error was 4.4 +/- 13.9 degrees for VISX S4 versus 14.9 +/- 23.9 degrees for VISX CustomVue (P = .0085), and 6.1 +/- 12.30 for LADARVision versus 3.9 +/- 11.1 degrees for LADAR CustomCornea (P = .3501). Of the VISX CustomVue eyes, 32% had an absolute angle of error > 10 degrees, as compared to 10% for both the VISX S4 and LADAR CustomCornea eyes (P = .013), and 16% for the LADARVision group (P = .056). CONCLUSIONS: Wavefront-guided ablation is associated with higher surgically induced astigmatism and larger astigmatic axis shift on the VISX platform as compared to the LADAR CustomCornea and the LADAR and VISX conventional platforms. Care should be emphasized mainly during registration/alignment to minimize surgically induced astigmatism in wavefront-guided LASIK.     

First clinical experience with the Alcon LADAR 6000 excimer laser

PURPOSE: To evaluate the reliability and ergonomics and to assess the first clinical results provided by the new LADAR 6000 excimer laser used to correct myopia and astigmatism, both by conventional and wavefront-guided ablation. METHODS: Seventy-four consecutive eyes from 37 patients underwent LASIK as the first field evaluation protocol of the Alcon LADAR 6000 excimer laser. Forty-six eyes were treated by wavefront-guided ablation to correct a manifest spheroequivalent refractive error (MSRE) of -0.50 to -9.75 diopters (D) (mean: -4.19 D, cylinder range: 0.0 to -3.50 D). Twenty-eight eyes were treated by conventional ablation to correct MSRE of -1.00 to -7.00 D (mean: -3.11 D, cylinder range: 0.0 to -1.75 D). Uncorrected (UCVA) and best spectacle-corrected visual acuity (BSCVA), MSRE, and wavefront measurements were assessed. Follow-up was 3 months for all eyes. RESULTS: Three months after surgery, all eyes were within +/- 1.00 D of intended correction. Forty-three (93.5%) eyes treated with wavefront-guided ablation and 25 (89.3%) eyes treated with conventional ablation were within +/- 0.50 D. All eyes reached > or = 20/25 UCVA. UCVA > or = 20/20 was reached in 45 (97.8%) wavefront-guided eyes and 26 (92.9%) conventional eyes; 37 (80.4%) wavefront-guided eyes and 17 (60.7%) conventional eyes had 20/16 UCVA. None of the eyes treated lost > or = 2 lines of BSCVA. CONCLUSIONS: The LADAR 6000 excimer laser results proved to be at least as accurate, predictable, and safe as the results currently achieved with the LADARVision4000 excimer laser. The improved microscope illumination enhances visibility for better consistency and ease of use. The better ergonomics and software design of this platform improved patient flow.     

Wavefront-guided laser in situ keratomileusis with the Alcon CustomCornea and the VISX CustomVue: three-month results

PURPOSE: To evaluate and compare the visual and clinical outcomes of wavefront-guided laser in situ keratomileusis (LASIK) with the Alcon CustomCornea (Alcon Laboratories Inc, Fort Worth, Tex) and VISX CustomVue (VISX, Santa Clara, Calif) systems. METHODS: Ninety-three eyes of 56 patients (50 and 43 consecutive eyes on CustomCornea and CustomVue, respectively) were enrolled in a prospective multisurgeon clinical outcome study. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), and manifest refraction were measured at 1 day, 1 week, 1 month, and 3 months postoperatively. Early treatment diabetic retinopathy study (ETDRS) visual acuity and contrast sensitivity were measured at 1 month and 3 months, and wavefront mapping at 3 months. RESULTS: Preoperatively, the CustomCornea group had a mean sphere of -3.90 +/- 1.62 diopters (D) (range -0.50 to -7.25 D), mean cylinder of +0.62 +/- 0.39 D (range 0 to +1.50 D), and mean manifest spherical equivalent refraction of -3.59 +/- 1.54 D. The CustomVue group had a sphere of -3.87 +/- 1.45 D (range -1.75 to -6.75 D), cylinder of +0.49 +/- 0.36 D (range 0 to +1.50 D), and manifest spherical equivalent refraction of -3.62 +/- 1.46 D. At 3 months, 98% of the CustomCornea group and 95% of the CustomVue group were within +/-0.50 D. Ninety-nine percent of eyes did not change >0.50 D (manifest spherical equivalent refraction) between 1 month and 3 months. CustomCornea eyes improved on contrast sensitivity testing and had a better profile than CustomVue for 20/15 Snellen and 20/12.5 ETDRS acuity. Both laser groups had a decrease in higher order aberrations with statistical significance for coma and spherical aberration in the CustomCornea group. CONCLUSION: Wavefront-guided LASIK with both systems is safe and effective.     

Expanded range customcornea algorithms for myopia and astigmatism: one-month results

PURPOSE: To evaluate the early clinical results achieved with an algorithm adjusted for an expanded range of correction in wavefront-guided customized ablation with the LADARVision4000 (Alcon Laboratories Inc, Fort Worth, Tex). METHODS: Fifty-five consecutive eyes from 31 patients underwent wavefront-guided, customablation laser in situ keratomileusis (LASIK) (Hansatome and BD 4000 microkeratomes, LADARWave aberrometer, LADARVision4000 laser system). These were normal myopic and astigmatic eyes that had never been operated on. The spherical equivalent refractive error was +0.30 to -8.13 diopters (D) (mean -4.26 +/- 2.14 D) and the astigmatism ranged from 0 to -3.75 D (mean -0.97 +/- 0.96 D). eyes were treated according to the CustomCornea protocol using the commercial LADARVision4000 platform. Patients were followed for at least 2 months and standard visual measurements were taken and recorded at 1 day and 1, 3, and 6 months after treatment. The results of treatment were assessed using the following parameters: uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA); manifest spherical equivalent refractive error; wavefront measurement of high order aberrations; and subjective reports of visual symptoms by patients. RESULTS: One month after LASIK, the mean manifest spherical equivalent refractive error was -0.18 +/- 0.41 D. Seventy-eight percent and 96% of eyes had manifest spherical equivalent refractive error within +/-0.50 D and +/-1.00 D of attempted correction, respectively, with 78% of eyes with 20/20 or better UCVA. Eyes with 20/16 and 20/12.5 BSCVA were 89% and 36%, respectively (55% and 7% preoperatively). The mean high order aberrations root-mean-square was 0.34 +/- 0.10 microm preoperatively and 0.35 +/- 0.09 microm postoperatively (6.0-mm pupil size). High order aberrations were either reduced, unchanged, or increased by <10% in 58% of eyes. Subjectively, patients reported no visual symptoms and had no complaints regarding the quality of their vision. CONCLUSION: The new optimized algorithm for higher refractive errors appears to be effective in improving BSCVA, and a minority of patients demonstrated an increase in the magnitude of high order aberrations when compared to preoperative aberrometry. A slight spherical equivalent refraction undercorrection will be addressed with future nomogram adjustments.     

Wavefront-guided LASIK for myopia using the LADAR CustomCornea and the VISX CustomVue

PURPOSE: To evaluate the objective and subjective visual outcomes and refractive results of wavefront-guided LASIK with LADAR CustomCornea and VISX CustomVue. METHODS: This prospective randomized single-institution multisurgeon study comprised 100 eyes of 58 patients (50 eyes on each laser platform). Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), and manifest refraction were measured postoperatively at 1 day, 1 week, 1 month, and 3 months. Contrast sensitivity, higher order aberrations measurement, and a subjective vision questionnaire were performed preoperatively and at 3 months. RESULTS: Preoperatively, the CustomCornea group had a mean manifest sphere of -3.58 +/- 1.61 diopters (D) (range: -0.50 to -7.25 D), cylinder of +0.64 +/- 0.45 D (range: 0 to +1.75 D), and manifest refractive spherical equivalent (MRSE) of -3.26 +/- 1.56 D. The CustomVue group had a manifest sphere of -4.00 +/- 1.69 D (range: -1.50 to -7.50 D), cylinder of +0.60 +/- 0.52 D (range: 0 to +2.00 D), and MRSE of -3.70 +/- 1.64 D. At 3 months, 94% of CustomCornea eyes and 84% of CustomVue eyes had UCVA > or = 20/20 (P = .20). Twenty-four percent of CustomVue eyes and 22% of CustomCornea eyes gained 1 line of BSCVA. In both groups, 96% of eyes were within 0.50 D of emmetropia. Mean CustomCornea glare contrast sensitivity improved (P = .04) whereas more eyes improved than worsened in both groups. Spherical aberration and total higher order aberrations increased, and trefoil decreased in both groups. A decrease in coma was noted in 70% of CustomCornea eyes. CONCLUSIONS: Wavefront-guided LASIK with both platforms is safe, effective, and delivers excellent visual results. CustomCornea improves contrast sensitivity under glare conditions.     

Comparison of the toric implantable collamer lens and custom ablation LASIK for myopic astigmatism

PURPOSE: To compare the results of wavefront-guided custom LASIK and the Toric Implantable Collamer Lens (TICL) in the correction of myopic astigmatism. METHODS: This observational, non-randomized study compared clinical efficacy results from the TICL's US Food and Drug Administration Clinical Trial and published Summaries of Safety and Effectiveness of two wavefront-guided lasers: STAR S4 CustomVue excimer laser system (VISX Inc) and LADARVision4000 CustomCornea excimer laser system (Alcon Laboratories Inc). Preoperative myopic refractive error was divided into two groups: -3.00 to -7.00 diopters (D) and -7.00 to -11.00 D. RESULTS: The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 and 20/40 and predictability of manifest refraction spherical equivalent within +/- 0.50 and +/- 1.00 D in the three groups was similar with only one statistically significant difference (TICL versus Alcon within +/- 1.00 D: 97% versus 82%; P = .008). The TICL had significantly better postoperative best spectacle-corrected visual acuity (BSCVA) compared to preoperative BSCVA than both the VISX CustomVue and Alcon CustomCornea (P < .001). The TICL postoperative UCVA outcomes compared to preoperative BSCVA were significantly better than Alcon CustomCornea outcomes (P < .001). Additionally, almost half (48%) of the TICL cases had improvement in postoperative UCVA compared to preoperative BSCVA, whereas only 23% of the Alcon CustomCornea eyes showed improvement. CONCLUSIONS: Although comparable in clinical efficacy outcomes, the TICL had a significantly better postoperative improvement in BSCVA and significantly better postoperative UCVA than preoperative BSCVA. The TICL can be considered as an alternative to LASIK through the full range of use.     

Comparison of higher-order aberrations after wavefront-guided laser in situ keratomileusis and laser-assisted subepithelial keratectomy

PURPOSE: To compare the higher-order aberrations (HOAs) in 70 eyes (38 patients) that had wavefront-guided laser in situ keratomileusis (LASIK) with those in 70 eyes (40 patients) that had wavefront-guided laser-assisted subepithelial keratectomy (LASEK) for the treatment of myopia. SETTING: Department of Ophthalmology, Yonsei University College of Medicine, Myongdong Bal-geun sesang Eye Clinic, and Seran Eye Center, Seoul, Korea. METHODS: In a prospective study, 140 consecutive eyes of 78 patients were treated with wavefront-guided LASIK or LASEK according to the patient's choice after each procedure had been thoroughly explained. The patients were followed for 6 months. Best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), manifest refraction, and wavefront aberrations were measured at baseline and 1, 3, and 6 months after surgery. RESULTS: There were no significant differences in postoperative BCVA, UCVA, and manifest refraction between groups. The mean root-mean-square wavefront error of HOAs for a scotopic pupil in the wavefront-guided LASIK group was significantly smaller than that in the wavefront-guided LASEK group at 1 month. Analyzing individual Zernike coefficients, the spherical aberration and second coma were significantly smaller in the wavefront-guided LASIK group than in the wavefront-guided LASEK group at 1 month. This difference in HOAs between groups disappeared at 3 and 6 months. CONCLUSIONS: The HOAs in the scotopic condition were not different between the wavefront-guided LASIK and LASEK groups beginning 3 months after surgery. However, the HOAs in the LASIK and LASEK groups had a different time course, especially in the case of spherical aberration. This finding suggests that postoperative changes in aberration contribute to the final outcome of wavefront-guided ablation.     

Alcon LADARWave customcornea retreatments

PURPOSE: To present our experience performing wavefront-guided ablations for the treatment of residual refractive error following previous refractive surgery. METHODS: Four different cases are presented-1) primary wavefront-guided LASIK; 2) wavefront-guided lift-flap LASIK retreatment; 3) wavefront-guided photorefractive keratectomy (PRK) retreatment; and 4) wavefront-guided PRK over radial keratotomy retreatment. All procedures were performed with the Alcon CustomCornea laser platform. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, and wavefront analysis (6.5-mm pupil) were performed preoperatively and 3 months after CustomCornea retreatment. The Alcon LADARWave device was used for wavefront measurements. RESULTS: Total lower order and higher order aberrations were decreased following wavefront-guided retreatment, resulting in improved quality of vision. The maximum target offset (+ 0.75 diopters) can be used to prevent an overcorrection of defocus (myopia) when treating a significant amount of spherical aberration. CONCLUSIONS: Wavefront-guided ablation was an effective treatment for residual lower and higher order aberrations following previous refractive surgery. Custom ablation treatment algorithms need to be developed specifically for retreatment procedures.     

Nomogram adjustment of laser in situ keratomileusis for myopia and myopic astigmatism with the Alcon LADARVision system

PURPOSE: To evaluate the visual and refractive results of conventional (non-wavefront) laser in situ keratomileusis (LASIK) for treatment of myopia and myopic astigmatism using the Alcon LADARVision 4000 excimer laser system and nomogram adjustment techniques. METHODS: A retrospective analysis of 499 eyes that had LASIK for myopia and myopic astigmatism was performed. Preoperative manifest spherical equivalent refraction ranged from -0.43 to -6.00 D and preoperative astigmatism ranged from 0 to -4.75 D. Patients were evaluated during 3 months following surgery. RESULTS: One month after surgery, 72% of eyes examined (298/415 eyes) had uncorrected visual acuity (UCVA) of 20/20 or better. Three months after surgery, 83% of eyes examined (216/261 eyes) had UCVA of 20/20 or better. One and three months after surgery, 82% and 83% of eyes, respectively, were within +/-0.50 D of attempted correction; 97% of eyes were within +/-1.00 D at both 1 and 3 months. No eye lost more than 1 line of best spectacle-corrected visual acuity (BSCVA) at 3 months after surgery. At the 3-month examination, 83% of eyes had UCVA better than or equal to preoperative BSCVA. CONCLUSIONS: Conventional LASIK to correct myopia and myopic astigmatism was safe and effective using the Alcon LADARVision 4000 excimer laser system. Outcomes were substantially improved throughout development of an accurate nomogram, derived from continually updated regression analysis of previous refractive results.     

Prospective randomized trial of wavefront-guided laser in situ keratomileusis with the CustomCornea and CustomVue laser systems

PURPOSE: To compare visual function, safety, and higher-order aberrations (HOAs) after wavefront-guided laser in situ keratomileusis (LASIK) with the LadarVision CustomCornea (Alcon Laboratories, Inc.) and Star S4 CustomVue (Visx) laser systems. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. METHODS: Seventy-eight eyes of 39 patients with myopia with or without astigmatism were randomized for LASIK treatment in 1 eye with the CustomCornea laser; the other eye was treated with the CustomVue laser. Patients were followed for 6 months after surgery. The primary outcome measures were uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, and changes in HOAs. RESULTS: At 6 months, the mean logarithm of the minimum angle of resolution (logMAR) UCVA was -0.0135 +/- 0.07 (SD) in the CustomVue group and 0.0417 +/- 0.12 in the CustomCornea group (P = .023). Eighty-eight percent of eyes in the CustomVue group had 20/20 or better UCVA compared with 67% in the CustomCornea group (P<.02). At 6 months, 91% of eyes in the CustomVue group and 79% in the CustomCornea group were within +/-0.50 diopter (D) of emmetropia (P<.1); 88% and 50%, respectively, were within +/-0.25 D (P<.001). Both platforms led to a small increase in total HOAs. The CustomVue system reduced trefoil and induced less of an increase in total HOAs, whereas the CustomCornea platform increased trefoil but induced less of an increase in spherical aberrations and coma. CONCLUSIONS: Both laser systems were effective, safe, and predictable. Wavefront-guided LASIK with the CustomVue system resulted in better visual acuity, with more eyes having 20/20 acuity than in the CustomCornea group.     

Wavefront-guided treatment for previous laser in situ keratomileusis and photorefractive keratectomy: case reports

PURPOSE: To describe the off-label use of the Alcon LADARVision System for CustomCornea (LADARWave and LADARVision4000) in two patients, one for retreatment after laser in situ keratomileusis (LASIK) and one for retreatment after photorefractive keratectomy (PRK). METHODS AND RESULTS: Both patients were unhappy with the quality of their vision after initial refractive surgery. The first patient initially had LASIK to correct -4.75 D of myopia in each eye, and then had retreatment with CustomCornea. Before retreatment, manifest refraction was OD 0.50 -0.50 x 180 degrees (20/25 uncorrected) and OS -0.50 -0.75 x 180 degrees (20/40 uncorrected). Two months after retreatment with CustomCornea, his uncorrected visual acuity OD was 20/15, and 1 month after retreatment in his left eye, uncorrected visual acuity was 20/15. The second patient had PRK OD, with a postoperative uncorrected visual acuity of 20/25 and cycloplegic refraction of +1.00 -0.75 x 84 degrees. After CustomCornea retreatment, his 3.5-month postoperative uncorrected visual acuity was 20/15 and manifest refraction was +0.50 -0.50 x 180 degrees. CONCLUSION: The Alcon LADARVision System for CustomCornea was used effectively to retreat both a myopic LASIK and myopic PRK patient, primarily for subjective quality of night vision complaints.     

Randomized comparison of custom laser in situ keratomileusis with the Alcon CustomCornea and the Bausch & Lomb Zyoptix systems: one-month results

PURPOSE: To compare the early visual results of custom laser in situ keratomileusis (LASIK) outcomes for two different excimer laser systems. METHODS: This is a preliminary report of an ongoing prospective study that evaluated 30 patients (60 eyes) who were randomized to one of two custom LASIK treatment groups: 15 patients (30 eyes) with the Alcon CustomCornea laser system (Alcon Laboratories Inc, Fort Worth, Tex) and 15 patients (30 eyes) with the Bausch & Lomb Zyoptix laser system (Bausch & Lomb, Rochester, NY). These matched patients were required to qualify for treatment with both custom laser systems. All flaps were created with the IntraLase femtosecond laser (IntraLase Corp, Irvine, Calif) using a superior hinge. Early outcome measures are uncorrected visual acuity (UCVA) at 1 day, 1 week, and 1 month postoperative; manifest refractions at 1-month follow-up; and a comparison of 1-month postoperative UCVA to preoperative best spectacle-corrected visual acuity (BSCVA). Wavefront, topography, contrast sensitivity, and subjective questionnaires were also performed and will be reported after 3-month follow-up. RESULTS: At 1 month, the percentage of eyes with UCVA of 20/20 and 20/40 were similar with 93% and 100%, respectively, for CustomCornea eyes and 90% and 97%, respectively, for Zyoptix eyes. A difference between the two groups is in the percentage of eyes with UCVA of 20/16, 20/12.5, and 20/10 with 80%, 47%, and 13%, respectively, for CustomCornea and 70%, 10%, and 0%, respectively, for Zyoptix. The mean residual spherical equivalent refraction was +0.01 +/- 0.34 diopters (D) for CustomCornea and -0.04 +/- 0.38 D for Zyoptix. The two groups are similar at +/-1.00 D of intended correction, with CustomCornea 100% and Zyoptix 97%. However, +/-0.25 D the CustomCornea group was 10% more accurate at 73% versus 63% for the Zyoptix group. The efficiency ratio (postoperative UCVA compared to preoperative BSCVA) was greater for the CustomCornea group at 20/20, 20/16,20/12.5, and 20/10 levels. CONCLUSION: Custom LASIK with CustomCornea and Zyoptix is safe and effective and produces excellent early visual outcomes. This study demonstrates that current standard metrics for reporting refractive surgery visual outcomes are not adequate for evaluating wavefront-guided laser vision correction procedures. Amending the standard reporting metrics to include visual outcomes at the 20/16, 20/12.5, and 20/10 levels; accuracy at the +/-0.25 D of attempted; and postoperative UCVA compared to preoperative BSCVA will improve our ability to analyze wavefront-guided outcomes.     

Wavefront-guided treatment of abnormal eyes using the LADARVision platform

PURPOSE: To evaluate the clinical results of Alcon LADARVision4000 wavefront-guided customized treatment of eyes with myopia and/or astigmatism, and clinically significant visual symptoms related to the presence of higher order aberrations. METHODS: Seven consecutive abnormal eyes from seven patients underwent wavefront-guided CustomCornea (1 PRK, 6 enhancements after previous LASIK) to correct low and higher order aberrations, using the Alcon LADARVision4000 platform. Eyes were examined at 1 to 3 months after treatment; the longest follow-up examination was used for analysis. Uncorrected and best spectacle-corrected visual acuity, manifest refractive spherical equivalent error, and subjective visual symptoms were measured, as well as wavefront measurement of higher order aberrations. RESULTS: All seven eyes had an improvement in UCVA. One eye gained 2 lines of BSCVA, four eyes gained 1 line, and no eye lost any lines. Manifest refractive spherical equivalent error was slightly hyperopic in all eyes (+0.12 to +1.50 D). All eyes showed a reduction in pre-existing higher order aberrations, ranging between 1% and 48%. Spherical aberration was reduced most (mean 38% reduction), coma was reduced by a mean 14%, and all other terms were reduced by a mean 17% compared to preoperative values. Subjectively, all patients noticed a reduction in their pre-existing visual symptoms and reported visual performance comparable to their fellow asymptomatic eye. Overall, the treatment was considered very satisfactory by patients in terms of visual quality gain. CONCLUSION: Wavefront-guided custom ablation with Alcon's LADARVision4000 was effective in reducing higher order aberrations and related visual symptoms in this preliminary small series. Longer follow-up on more eyes is necessary to assess the accuracy of the algorithm in the correction of defocus, which resulted in a slight overcorrection in this study.     

Laser in situ keratomileusis with Alcon CustomCornea

PURPOSE: To report the 3-month results of our first cases of laser in situ keratomileusis (LASIK) with Alcon's CustomCornea. METHODS: Wavefront analysis was performed using the LADARWave aberrometer and ablation was performed with the LADARVision4000 system. Thirty-one eyes of 17 patients were analyzed prospectively, at 1 and 3 months after CustomCornea surgery. Psychophysical tests were performed, including high and low contrast acuity, and contrast sensitivity under scotopic and photopic conditions. In addition, psychometric testing was performed using a subjective vision questionnaire. RESULTS: Mean spherical equivalent refraction improved from a baseline -3.05 +/- 1.92 D to +0.02 +/- 0.28 D at 3 months (28 eyes). At 3 months, 46.4% (13 eyes) had uncorrected visual acuity of 20/16, 92.7% (26 eyes) had 20/20, and 100% (28 eyes) had 20/25 uncorrected visual acuity. Three months after CustomCornea surgery, there was a statistically significant improvement in contrast sensitivity under both scotopic and photopic conditions, and a statistically significant increase in third and fourth order aberrations. There was a statistically significant improvement in visual quality as measured by the subjective vision index, increasing from a preoperative mean 66.62 to 87.63 at 3 months after surgery. CONCLUSIONS: CustomCornea was an improvement over conventional LASIK as measured by most psychophysical and psychometric parameters. The relationship between higher order aberrations and other psychophysical and psychometric measurements needs more analysis.     

Higher order aberrations and relative risk of symptoms after LASIK

PURPOSE: To understand what level of higher order aberrations increases the relative risk of visual symptoms in patients after myopic LASIK. METHODS: This study was a retrospective comparative analysis of 103 eyes of 62 patients divided in two groups, matched for age, gender, pupil size, and spherical equivalent refraction. The symptomatic group comprised 36 eyes of 24 patients after conventional LASIK with different laser systems evaluated in our referral clinic and the asymptomatic control group consisted of 67 eyes of 38 patients following LADARVision CustomCornea wavefront LASIK. Comparative analysis was performed for uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), contrast sensitivity, refractive cylinder, and higher order aberrations. Wavefront analysis was performed with the LADARWave aberrometer at 6.5-mm analysis for all eyes. RESULTS: Blurring of vision was the most common symptom (41.6%) followed by double image (19.4%), halo (16.7%), and fluctuation in vision (13.9%) in symptomatic patients. A statistically significant difference was noted in UCVA (P = .001), BSCVA (P = .001), contrast sensitivity (P < .001), and manifest cylinder (P = .001) in the two groups. The percentage difference between the symptomatic and control group mean root-mean-square (RMS) values ranged from 157% to 206% or 1.57 to 2.06 times greater. CONCLUSIONS: Patients with visual symptoms after LASIK have significantly lower visual acuity and contrast sensitivity and higher mean RMS values for higher order aberrations than patients without symptoms. Root-mean-square values of greater than two times the normal after-LASIK population for any given laser platform may increase the relative risk of symptoms.     

Higher order aberrations after LASIK for myopia with alcon and wavelight lasers: a prospective randomized trial

PURPOSE: To evaluate the differences in higher order aberration outcomes between bilateral wavefront-guided and wavefront-optimized LASIK treatments on two closely matched patient groups 1 and 3 months following surgery. METHODS: Thirty patients were enrolled in the study and randomly assigned to undergo bilateral LASIK with either the Alcon CustomCornea laser system or the WaveLight Allegretto Wave laser system. Standard clinical outcomes such as visual acuity and manifest refraction were evaluated as well as quality of vision measures such as subjective questionnaires and higher order aberrations. All patients completed follow-up examinations for 3 months following surgery. RESULTS: At 1 and 3 months after surgery, the uncorrected visual acuity and the refractive outcome were similar for the two laser platforms, with 90% to 93% eyes being within +/- 0.5 D of intended outcome. At 1 and 3 months the Alcon CustomCornea group had a statistically significant lower amount of induced total higher order aberrations compared to the Allegretto Wave group (P < .05). CONCLUSIONS: LASIK for myopia with the Alcon CustomCornea and WaveLight Allegretto Wave systems is highly effective in terms of refractive outcome and uncorrected visual acuity. However, aberrations were statistically significantly greater after treatment with the WaveLight Allegretto Wave system than with the Alcon CustomCornea.     

Wavefront-guided laser in situ keratomileusis retreatment for consecutive hyperopia and compound hyperopic astigmatism

PURPOSE: To evaluate the efficacy, predictability, and safety of wavefront-guided laser in situ keratomileusis (LASIK) using the Visx CustomVue excimer laser (Advanced Medical Optics) in eyes with consecutive hyperopia and compound hyperopic astigmatism after LASIK. SETTING: Stanford University School of Medicine, Department of Ophthalmology, Stanford, California, USA. METHODS: This retrospective analysis included 19 eyes of 16 patients who had wavefront-guided LASIK for consecutive hyperopia and compound hyperopic astigmatism after initial LASIK surgery. Primary outcome variables, including uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), higher-order aberration (HOA) analysis, and spherical equivalence, were evaluated at 1 and 3 months. Nine eyes of 7 patients were available for all visits. RESULTS: The mean patient age was 51.7 years +/- 3.77 (SD) (range 44 to 55 years). The mean preoperative manifest refractive spherical equivalent (MRSE) was 0.99 +/- 0.32 diopters (D) (range 0.50 to 1.50 D) and the mean 3-month postoperative MRSE, -0.04 +/- 0.66 D (range -1.50 to 0.75 D). At 1 month, 57.9% of eyes had a UCVA of 20/20 or better and 78.9% of 20/25 or better; 84.2% were within +/-1.00 D of emmetropia. At 3 months, 66.7% of eyes had a UCVA of 20/20 or better and 88.9% of 20/25 or better; 88.9% were within +/-1.00 D of emmetropia. No eye lost 2 or more lines of BSCVA at 1 or 3 months. CONCLUSION: Wavefront-guided LASIK was an effective, predictable, and safe procedure for consecutive hyperopia and compound hyperopic astigmatism after LASIK.     

Complex wavefront-guided retreatments with the Alcon CustomCornea platform after prior LASIK

PURPOSE: To report the results of complex wavefront-guided LASIK retreatments. METHODS: Twenty eyes (15 patients) with histories of conventional LASIK surgery and significant visual complaints of glare and halos due to higher order aberrations were treated. Wavefront-guided retreatments were performed with the LADARVision CustomCornea system (Alcon, Ft Worth, Tex). Pre- and postoperative topographies, wavefront measurements, and subjective reports were analyzed. RESULTS: Postoperatively, patients had an expanded optical zone, many with improved centration. Lower and higher order aberrations decreased following wavefront-guided ablation. Mean higher order root-mean-square decreased from 1.01 +/- 0.25 microm preoperatively to 0.84 +/- 0.23 microm postoperatively. Mean coma decreased from 0.59 +/- 0.26 microm to 0.43 +/- 0.21 microm. Mean spherical aberration decreased from 0.66 +/- 0.25 microm to 0.54 +/- 0.27 microm. Subjective reports of glare and halo symptoms improved in all patients. CONCLUSIONS: CustomCornea wavefront-guided treatments are effective in reducing lower and higher order aberrations, expanding optical zones, and improving subjective reports of adverse aberration sequelae such as glare and halos.     

CustomVue laser in situ keratomileusis treatment after previous keratorefractive surgery

PURPOSE: To evaluate the efficacy, predictability, and safety of Visx CustomVue wavefront-guided enhancement after previous keratorefractive surgery. SETTING: Stanford University Eye Laser Center, Stanford, California, USA. METHODS: A retrospective analysis was used to evaluate wavefront-guided enhancement in a preliminary set of 120 eyes of 102 patients. All eyes had previous keratorefractive surgery (photorefractive keratoplasty [PRK] in 1 eye, laser in situ keratomileusis [LASIK] in 119 eyes); the prekeratorefractive surgery spherical equivalent (SE) refraction ranged from -1.25 diopters (D) to -7.00 D. Primary outcome variables including uncorrected visual acuity (UCVA), manifest refraction, and complications were evaluated at 1 and 3 months. RESULTS: At 1 month, the mean pre-enhancement SE was reduced from -0.91 D +/- 0.40 (SD) (range -2.375 to -0.125 D) to -0.13 +/- 0.33 D (range -1.25 to 0.75 D) with 91% of eyes within +/-0.5 D of emmetropia and 100% within +/-1.0 D. All eyes showed equal or improved UCVA (range 20/15 to 20/30) with 20/20 or better in 84 of 91 eyes. At 3 months, the mean was -0.20 +/- 0.32 D (range -0.75 to 0.75 D) with 100% of eyes within +/-0.75 D of emmetropia. All eyes showed equal or improved UCVA (range 20/15 to 20/30) with 20/20 or better in 74 of 84 eyes. Higher-order wavefront aberration analysis showed that the mean root-mean-square error was reduced from 0.39 +/- 0.14 microm (range 0.16 to 0.86 microm) to 0.34 +/- 0.12 microm (range 0.12 to 0.78 microm). Coma was reduced from 0.22 +/- 0.13 microm (range 0.02 to 0.71 microm) to 0.16 +/- 0.11 microm (range 0.01 to 0.62 microm), and trefoil was reduced from 0.16 +/- 0.09 microm (range 0.01 to 0.62 microm) to 0.11 +/- 0.07 microm (range 0.01 to 0.27 microm). Spherical aberration was unchanged from 0.14 +/- 0.14 microm (range -0.18 to 0.59 microm) to 0.14 +/- 0.14 microm (range -0.16 to 0.5 microm). CONCLUSION: Preliminary data show that Visx CustomVue wavefront-guided enhancement after keratorefractive surgery is an effective, predictable, and safe procedure.