Effect of residual sphere on uncorrected visual acuity and satisfaction in patients with monofocal and multifocal intraocular lenses.

PURPOSE: To assess the effect of residual sphere on vision and satisfaction in pseudophakic patients. SETTING: Private clinics, United Kingdom. DESIGN: Retrospective case series. METHODS: A multivariate model evaluated the effect of 1-month residual sphere on outcomes of pseudophakic patients. Odds ratios (ORs) were calculated to assess the relative risk of not achieving ≥20/20 monocular uncorrected distance visual acuity (UDVA), ≥20/50 uncorrected near visual acuity (UNVA), and not being satisfied with vision. ORs were assessed for residual sphere -1.00 to +1.00 diopter (D) in quarter-diopter steps, using 0.00 D as a reference. RESULTS: The analysis included 38 828 multifocal and 11 571 monofocal intraocular lenses (IOLs). The residual myopic sphere ≤-0.25 D and hyperopic sphere ≥+0.50 D had a clinically meaningful effect on UDVA. Although monofocal IOLs had an improvement in UNVA with every additional 0.25 D of myopia, the change in ORs with increasing myopia was not significant for multifocal IOLs. The mean improvement in UNVA comparing eyes with 0.00 D and -1.00 D sphere was 0.26 logMAR for monofocal and 0.03 logMAR for multifocal IOLs. Low near-addition IOLs had a slightly higher gain in UNVA with increasing myopia, but the gain was not as substantial as with monofocal IOLs. The effect of ametropia on satisfaction was more pronounced for multifocal IOLs. For every 0.25 D of residual myopia, there was >25% increase in dissatisfied patients. CONCLUSIONS: Although myopia improved UNVA in eyes with monofocal IOL, multifocal IOLs did not benefit from residual myopia. Multifocal IOL patients desiring distance vision should be targeted closest to emmetropia, even if it means targeting slight hyperopia.

Comparison of the 1st Generation and 3rd Generation Wavefront-Guided LASIK for the Treatment of Myopia and Myopic Astigmatism.

Purpose: To compare refractive, visual, and patient-reported outcomes associated with a 1st generation wavefront-guided (WFG) treatment with those associated with a 3rd generation WFG treatment. Patients and Methods: This retrospective study included patients who underwent femtosecond laser-assisted in situ keratomileusis (LASIK) for myopia/myopic astigmatism. Two random stratified samples of patients who underwent either 1stgeneration (WaveScan, Johnson & Johnson Vision, Santa Ana, CA) or 3rd generation (iDesign 2.0, Johnson & Johnson Vision, Santa Ana, CA) treatment matched on preoperative refraction were compared (4290 eyes of 2145 patients in each group). One-month postoperative visual, refractive, and patient-reported outcomes were analyzed. Refractive and monocular visual acuity analyses were performed using one random eye of each patient. Results: The percentage of eyes achieving 20/20 or better uncorrected vision was 91.3% (1958/2145) in the 1st generation group and 95.9% (2056/2145) in the 3rd generation group (p<0.01). Binocularly, the percentage of patients with 20/20 or better UDVA was 97.0% (2080/2145) and 99.2% (2127/2145) in the 1st and 3rd generation groups, respectively (p<0.01). The mean postoperative MSE was -0.01 ± 0.33 D in the 1st generation group and +0.19 ± 0.33 D in the 3rd generation group (p<0.01). Postoperative refractive astigmatism had a mean value of -0.20 ± 0.26 D and -0.18 ± 0.24 D in the 1st and 3rd generation groups, respectively (p<0.01). The mean correction index of refractive astigmatism was 1.09 ± 0.53 in the 1st generation group and 1.02 ± 0.38 in the 3rd generation group, p<0.01. The overall percentage of patients satisfied with vision was 92.8% (1991/2145 patients) in the 1st generation group and 97.3% (2087/2145 patients) in the 3rd generation group (p<0.01). Conclusion: For the majority of postoperative variables, there were significant differences between 1st and 3rd generation treatments. The 3rd generation treatments had better visual acuity outcomes and higher patient satisfaction.

Effect of residual astigmatism on uncorrected visual acuity and patient satisfaction in pseudophakic patients.

PURPOSE: To evaluate the effect of residual astigmatism on postoperative visual acuity and satisfaction after intraocular lens (IOL) surgery. SETTING: Private practice, United Kingdom. DESIGN: Retrospective case series. METHODS: Postoperative data of patients who had previously undergone refractive lens exchange or cataract surgery were used in a multivariate regression model to assess the effect of residual astigmatism on 3 months postoperative monocular uncorrected distance visual acuity (UDVA) and patient satisfaction. The analysis was based on residual refraction in the dominant eye of each patient. Odds ratios were calculated to demonstrate the effect of increasing residual astigmatism on UDVA and satisfaction with separate calculations for monofocal and multifocal IOLs. RESULTS: Three months postoperative outcomes of 17 152 dominant eyes were used in multivariate regression analysis. Compared with eyes with 0.00 diopter (D) residual astigmatism, the odds of not achieving 20/20 vision in eyes with 0.25 to 0.50 D residual astigmatism increased by a factor of 1.7 and 1.9 (P < .0001) in monofocal and multifocal IOLs, respectively. For the residual astigmatism 0.75 to 1.00 D, the odds ratio for not achieving 20/20 vision compared with eyes with no astigmatism was 6.1 for monofocal and 6.5 for multifocal IOLs (P < .0001). The effect of residual astigmatism on satisfaction was more evident at the 0.75 to 1.00 D level, where the odds of not being satisfied with vision increased by a factor of 2.0 and 1.5 in patients with monofocal and multifocal IOLs, respectively (P < .0001). The orientation of astigmatism was not a significant predictor in multivariate analysis. CONCLUSIONS: Multivariate analysis in a large population of patients demonstrated that low levels of residual astigmatism can degrade visual acuity. Corneal astigmatism of 0.50 D or greater should be included in surgical planning.

Predictors of Patient Satisfaction After Refractive Lens Exchange With an Extended Depth of Focus IOL.

PURPOSE: To identify independent factors associated with postoperative satisfaction after refractive lens exchange with an extended depth of focus intraocular lens (EDOF IOL). METHODS: Patients who underwent a refractive lens exchange with bilateral implantation of the AT LARA 829MP IOL (Carl Zeiss Meditec, Jena, Germany) and attended the 3-month follow-up visit were included in the analysis (N = 351 patients). Demographics, preoperative and postoperative clinical parameters, and patient-reported outcomes were used in a regression model to determine predictors of 3-month postoperative satisfaction. RESULTS: The mean age of the study group was 58.2 ± 7.0 years (range: 45 to 79 years) and the mean preoperative sphere ranged between -12.50 and +6.75 diopters (D). At 3 months postoperatively, 86.6% of patients were very satisfied or satisfied with outcomes and 93.2% would recommend the procedure to their family or friends. Of all patients, 90.6% achieved binocular uncorrected distance visual acuity of 20/20 or better, 92.0% achieved binocular near vision of 20/50 or better, and 85.5% of eyes were within ±0.50 D of emmetropia. Logistic regression identified postoperative dry eye symptoms, binocular near and distance visual acuity, and glare symptoms as significant independent factors affecting patient satisfaction. CONCLUSIONS: Several factors were independently predictive of postoperative satisfaction after EDOF IOL implantation and addressing these may further improve patient satisfaction with the procedure, specifically, proper management of early symptoms of dry eye, ensuring good refractive predictability to maximize unaided vision, and counseling patients about the possibility of visual phenomena in the early postoperative period. [J Refract Surg. 2020;36(3):175-184.].

Monovision LASIK Versus Presbyopia-Correcting IOLs: Comparison of Clinical and Patient-Reported Outcomes.

PURPOSE: To compare clinical and quality of life outcomes between patients who underwent monovision LASIK and refractive lens exchange. METHODS: The study comprised 590 patients with refractive lens exchange and 608 patients with monovision LASIK available for 3-month postoperative clinical visits. All patients with refractive lens exchange had a Tecnis Symfony lens (Johnson & Johnson Vision Care, Inc., Santa Ana, CA) in at least one eye. Patients were divided into four refractive categories: moderate to high myopia, low myopia, plano presbyopia, and hyperopia. Three-month postoperative data were compared between monovision LASIK and refractive lens exchange for each group. RESULTS: Postoperatively, the percentage of patients with binocular uncorrected distance visual acuity of 20/20 or better, for monovision LASIK and refractive lens exchange, respectively, was as follows: moderate to high myopia: 84.7% vs 90.7% (P = .31), low myopia: 89.4% vs 85.2% (P = .45), plano presbyopia: 90.5% vs 89.9% (P = .90), and hyperopia: 77.5% vs 84.2% (P = .03). For near vision, the percentage with binocular near visual acuity of 20/40 or better (J5) at 40 cm was as follows: moderate to high myopia: 98.9% vs 90.7% (P < .01), low myopia: 100% vs 98.1% (P = .17), plano presbyopia: 96.8% vs 95.8% (P = .34), and hyperopia: 95.6% vs 95.7% (P = .96). There was a statistically significant difference in patient satisfaction in favor of monovision LASIK for moderate to high myopia (94.3% for monovision LASIK vs 79.1% for refractive lens exchange, P <.01). For all other refractive categories, there was no significant difference in patient satisfaction. All myopic patients with refractive lens exchange experienced more postoperative visual phenomena than patients with monovision LASIK. The plano presbyopia group had comparable visual phenomena between the two procedures. CONCLUSIONS: Monovision LASIK and refractive lens exchange are both reasonable options for presbyopic patients. [J Refract Surg. 2017;33(11):749-758.].

Refractive lens exchange in younger and older presbyopes: comparison of complication rates, 3 months clinical and patient-reported outcomes.

PURPOSE: To compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE). METHODS: A stratified, simple random sample of patients matched on preoperative sphere and cylinder was selected for four age categories: 45-49 years (group A), 50-54 years (group B), 55-59 years (group C), and 60-65 years (group D). Each group contained 320 patients. All patients underwent RLE with a multifocal intraocular lens at least in one eye. Three months postoperative refractive/visual and patient-reported outcomes are presented. RESULTS: The percentage of patients that achieved binocular uncorrected distance visual acuity 20/20 or better was 91.6% (group A), 93.8% (group B), 91.6% (group C), 88.8% (group D), P=0.16. Binocularly, 80.0% of patients in group A, 84.7% in group B, 78.9% in group C, and 77.8% in group D achieved 20/30 or better uncorrected near visual acuity (P=0.13). The proportion of eyes within 0.50 D of emmetropia was 84.4% in group A, 86.8% in group B, 85.7% in group C, and 85.8% in group D (P=0.67). There was no statistically significant difference in postoperative satisfaction, visual phenomena, dry eye symptoms, distance or near vision activities. Apart from higher rate of iritis in the age group 50-55 years, there was no statistically significant difference in postoperative complication rates. CONCLUSION: RLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes.

Outcomes and complications of excimer laser surgery in patients with collagen vascular and other immune-mediated inflammatory diseases.

PURPOSE: To assess refractive and visual outcomes and postoperative complications in a large number of patients with well-controlled collagen vascular and other immune-mediated inflammatory diseases. SETTING: Optical Express, Glasgow, United Kingdom. DESIGN: Retrospective case series. METHODS: The files were reviewed of patients who had collagen vascular and other immune-mediated inflammatory diseases and who had excimer laser surgery between 2008 and 2015. In all cases, the disease was well controlled with no flare or symptoms for a minimum of 6 months preoperatively. RESULTS: The study comprised 622 patients (1224 eyes) with 1 of the following underlying diseases: rheumatoid arthritis (50.6% of patients), systemic lupus erythematosus (19.5%), psoriatic arthritis (10.5%), sarcoidosis (10.0%), ankylosing spondylitis (6.4%), multiple sclerosis (1.9%), or scleroderma (1.1%). Laser in situ keratomileusis (LASIK) was performed in 1114 eyes (91.0%) and photorefractive keratectomy (PRK) in 110 eyes (9.0%). The mean follow-up was 10.9 months. The preoperative spherical equivalent ranged between -10.13 diopters (D) and +4.13 D (LASIK) and -9.50 D and +4.00 D (PRK). Postoperatively, 81.8% LASIK eyes and 82.3% PRK eyes were within ±0.50 D. The uncorrected distance visual acuity was 20/20 or better in 76.8% and 73.4%, respectively. Complications were mostly those that would be expected after excimer laser surgery in a population of patients without disease with the exception of 1 peripheral flap melt that responded to treatment with topical steroids. CONCLUSION: Excimer laser surgery can be safely performed in patients with well-controlled collagen vascular or other immune-mediated inflammatory disease. FINANCIAL DISCLOSURE: Dr. S.C. Schallhorn is a consultant to Abbott Medical Optics, Inc., Acufocus, Inc., and Carl Zeiss Meditec AG, and a global medical director for Optical Express. No other author has a financial or proprietary interest in any material or method mentioned.

Patient-reported outcomes 5 years after laser in situ keratomileusis.

PURPOSE: To assess vision-related, quality-of-life outcomes 5 years after laser in situ keratomileusis (LASIK) and determine factors predictive of patient satisfaction. SETTING: Optical Express, Glasgow, Scotland. DESIGN: Retrospective case series. METHODS: Data from patients who had attended a clinical examination 5 years after LASIK were analyzed. All treatments were performed using the Visx Star S4 IR excimer laser. Patient-reported satisfaction, the effect of eyesight on various activities, visual phenomena, and ocular discomfort were evaluated 5 years postoperatively. Multivariate regression analysis was performed to determine factors affecting patient satisfaction. RESULTS: The study comprised 2530 patients (4937 eyes) who had LASIK. The mean age at the time of surgery was 42.4 years ± 12.5 (SD), and the preoperative manifest spherical equivalent ranged from -11.0 diopters (D) to +4.88 D. Five years postoperatively, 79.3% of eyes were within ±0.50 D of emmetropia and 77.7% of eyes achieved monocular uncorrected distance visual acuity (UDVA) and 90.6% of eyes achieved binocular UDVA of 20/20 or better. Of the patients, 91.0% said they were satisfied with their vision and 94.9% did not wear distance correction. Less than 2.0% of patients noticed visual phenomena, even with spectacle correction. Major predictors of patient satisfaction 5 years postoperatively were postoperative binocular UDVA (37.6% variance explained by regression model), visual phenomena (relative contribution of 15.0%), preoperative and postoperative sphere and their interactions (11.6%), and eyesight-related difficulties with various activities such as night driving, outdoor activities, and reading (10.2%). CONCLUSION: Patient-reported quality-of-life and satisfaction rates remained high 5 years after LASIK. Uncorrected vision was the strongest predictor of satisfaction. FINANCIAL DISCLOSURE: Dr. S.C. Schallhorn is a consultant to Abbott Medical Optics, Inc., Zeiss Meditec AG, and Autofocus Inc. and a global medical director for Optical Express. No other author has a financial or proprietary interest in any material or method mentioned.

Outcomes of excimer laser enhancements in pseudophakic patients with multifocal intraocular lens.

PURPOSE: The aim of this study was to assess visual and refractive outcomes of laser vision correction (LVC) to correct residual refraction after multifocal intraocular lens (IOL) implantation. PATIENTS AND METHODS: In this retrospective study, 782 eyes that underwent LVC to correct unintended ametropia after multifocal IOL implantation were evaluated. Of all multifocal lenses implanted during primary procedure, 98.7% were refractive and 1.3% had a diffractive design. All eyes were treated with VISX STAR S4 IR excimer laser using a convectional ablation profile. Refractive outcomes, visual acuities, patient satisfaction, and quality of life were evaluated at the last available visit. RESULTS: The mean time between enhancement and last visit was 6.3±4.4 months. Manifest spherical equivalent changed from -0.02±0.83 D (-3.38 D to +2.25 D) pre-enhancement to 0.00±0.34 D (-1.38 D to +1.25 D) post-enhancement. At the last follow-up, the percentage of eyes within 0.50 D and 1.00 D of emmetropia was 90.4% and 99.5%, respectively. Of all eyes, 74.9% achieved monocular uncorrected distance visual acuity 20/20 or better. The mean corrected distance visual acuity remained the same before (-0.04±0.06 logMAR [logarithm of the minimum angle of resolution]) and after LVC procedure (-0.04±0.07 logMAR; P=0.70). There was a slight improvement in visual phenomena (starburst, halo, glare, ghosting/double vision) following the enhancement. No sight-threatening complications related to LVC occurred in this study. CONCLUSION: LVC in pseudophakic patients with multifocal IOL was safe, effective, and predictable in a large cohort of patients.

Flap lift and photorefractive keratectomy enhancements after primary laser in situ keratomileusis using a wavefront-guided ablation profile: Refractive and visual outcomes.

PURPOSE: To analyze results of wavefront-guided laser vision correction retreatments performed either by lifting the original flap or by surface ablation over the flap. SETTING: Optical Express, Glasgow, United Kingdom. DESIGN: Retrospective case series. METHODS: This retrospective study included patients grouped according to whether they had flap lift enhancement or photorefractive keratectomy (PRK) performed over the LASIK flap. All retreatment procedures were performed with the Visx Star S4 IR excimer laser with wavefront-guided ablation profile derived from the iDesign aberrometer. Visual acuities, refractive outcomes, vector analysis of refractive cylinder and complications were analyzed in this study. The results of the last available clinical visit are presented. RESULTS: This retrospective study included 290 eyes of 202 patients divided into 2 groups: 119 eyes that had flap lift enhancement (Group A), and 171 eyes in which photorefractive keratectomy (PRK) was performed over the LASIK flap (Group B). The mean follow-up was 4.0 ± 1.9 months in Group A and 4.2 ± 1.6 in Group B. The mean postoperative manifest spherical equivalent was -0.01 ± 0.35 D and +0.06 ± 0.39 D in Groups A and B, respectively. The percentage of eyes with postenhancement UDVA 20/20 or better was 87.4% in Group A and 79.5 % in Group B (P = .09). In Group A, 22 eyes (18.5%) developed epithelial ingrowth, of which surgical intervention was required in 2 eyes (1.7%). Grade 1 or less haze was noted in 9 (5.3%) eyes in Group B, and resolved in all cases within the first 6 postoperative months. CONCLUSION: Both retreatment techniques were considered to be effective, predictable, and safe. FINANCIAL DISCLOSURE: Steven C Schallhorn MD is a consultant to Abbott Medical Optics and Zeiss, and Global Medical Director for Optical Express. None of the other authors have a financial or proprietary interest in the products and materials presented in this paper.

Outcomes of wavefront-guided laser in situ keratomileusis using a new-generation Hartmann-Shack aberrometer in patients with high myopia.

PURPOSE: To evaluate refractive and visual outcomes of wavefront-guided laser in situ keratomileusis (LASIK) to correct high myopia using a new Hartmann-Shack aberrometer. SETTING: Optical Express, Glasgow, United Kingdom. DESIGN: Retrospective noncomparative case series. METHODS: Data of eyes that had wavefront-guided LASIK for high myopia and myopic astigmatism (spherical equivalent [SE] between -6.00 diopters [D] and -10.25 D, up to 5.00 D of cylinder) were analyzed. The treatment profile was derived from a new-generation Hartmann-Shack aberrometer (iDesign Advanced Wavescan). Visual acuities, refractive outcomes, vector analysis of refractive cylinder, and patient satisfaction were assessed. Three-months data are presented. RESULTS: Data were obtained for 621 eyes. The mean manifest SE reduced from -7.28 D ± 1.05 (SD) (range -10.25 to -6.00 D) preoperatively to -0.09 ± 0.44 D (range -2.13 to +1.38 D) at 3 months. The mean manifest cylinder changed from -1.02 ± 0.82 D (range -5.00 to 0.00 D) to -0.27 ± 0.33 D (range -1.75 to 0.00 D) postoperatively. The percentage of eyes achieving an uncorrected distance visual acuity 20/20 or better was 82.4% monocularly and 92.5% binocularly. The mean correction ratio of refractive cylinder was 1.02 ± 0.48, and the mean error of angle was -0.29 ± 14.56 degrees. A postoperative questionnaire revealed high satisfaction with the outcomes of the procedure, with low scores for night-vision phenomena. CONCLUSION: The results in this study were promising in terms of safety, efficacy, and predictability in eyes with high degrees of myopia. FINANCIAL DISCLOSURE: Dr. Schallhorn is a consultant to Abbott Medical Optics, Inc. No other author has a financial or proprietary interest in any material or method mentioned.

Wavefront-Guided Photorefractive Keratectomy with the Use of a New Hartmann-Shack Aberrometer in Patients with Myopia and Compound Myopic Astigmatism.

Purpose. To assess refractive and visual outcomes and patient satisfaction of wavefront-guided photorefractive keratectomy (PRK) in eyes with myopia and compound myopic astigmatism, with the ablation profile derived from a new Hartmann-Shack aberrometer. Methods. In this retrospective study, 662 eyes that underwent wavefront-guided PRK with a treatment profile derived from a new generation Hartmann-Shack aberrometer (iDesign aberrometer, Abbott Medical Optics, Inc., Santa Ana, CA) were analyzed. The preoperative manifest sphere ranged from -0.25 to -10.75 D, and preoperative manifest cylinder was between 0.00 and -5.25 D. Refractive and visual outcomes, vector analysis of the change in refractive cylinder, and patient satisfaction were evaluated. Results. At 3 months, 91.1% of eyes had manifest spherical equivalent within 0.50 D. The percentage of eyes achieving uncorrected distance visual acuity 20/20 or better was 89.4% monocularly and 96.5% binocularly. The mean correction ratio of refractive cylinder was 1.02 ± 0.43, and the mean error of angle was 0.00 ± 14.86° at 3 months postoperatively. Self-reported scores for optical side effects, such as starburst, glare, halo, ghosting, and double vision, were low. Conclusion. The use of a new Hartmann-Shack aberrometer for wavefront-guided photorefractive keratectomy resulted in high predictability, efficacy, and patient satisfaction.

Clinical outcomes of wavefront-guided laser in situ keratomileusis to treat moderate-to-high astigmatism.

PURPOSE: The purpose of this study was to evaluate the refractive and visual outcomes of wavefront-guided laser in situ keratomileusis (LASIK) in eyes with myopic astigmatism and cylindrical component ≥2.0 diopter (D). METHODS: In this retrospective study, 611 eyes that underwent LASIK for simple or compound myopic astigmatism were analyzed. Preoperative refractive cylinder ranged from -2.00 D to -6.00 D (mean -2.76±0.81 D), and the sphere was between 0.00 D and -9.75 D (mean -2.79±2.32 D). Predictability, visual outcomes, and vector analysis of changes in refractive astigmatism were evaluated. RESULTS: At 3 months after LASIK, 83.8% of eyes had uncorrected distance visual acuity of 20/20 or better, 90.3% had manifest spherical equivalent within ±0.50 D, and 79.1% had residual refractive cylinder within ±0.50 D of intended correction. The mean correction ratio for refractive cylinder was 0.92±0.14, the mean error of angle was -0.45°±2.99°, and the mean error vector was 0.37±0.38 D. A statistically significant correlation was found between the error of magnitude (arithmetic difference in the magnitudes between surgically induced refractive correction and intended refractive correction) and the intended refractive correction (r=0.26, P<0.01). CONCLUSION: Wavefront-guided LASIK for the correction of myopic astigmatism is safe, effective, and predictable.

Effect of postoperative keratometry on quality of vision in the postoperative period after myopic wavefront-guided laser in situ keratomileusis.

PURPOSE: To determine whether postoperative keratometry is a predictor of patient-reported satisfaction and night-vision phenomena after wavefront-guided myopic laser in situ keratomileusis (LASIK). SETTING: Optical Express, Glasgow, United Kingdom. DESIGN: Retrospective case series. METHODS: Myopic eyes treated with wavefront-guided LASIK were analyzed in this study. All patients completed pre-operative and 1-month postoperative questionnaires, in which the satisfaction with visual outcomes and pre-operative and postoperative night-vision symptoms (glare, halos, starburst, ghosting/double-vision) were rated. Multivariate regression analysis was performed to determine factors associated with questionnaire outcomes. RESULTS: This study evaluated 8672 myopic eyes of 4602 patients. The mean pre-operative manifest spherical equivalent was -3.72 diopters (D) ± 2.00 (SD) (range -0.50 to -11.00 D) and the mean pre-operative keratometry (K) value was 43.64 ± 1.43 D (38.38 to 49.00). At 1 month after surgery, 93.7% and 99.1% of eyes were within 0.50 D and 1.00 D of emmetropia, and 94.6% and 98.3% of eyes achieved monocular and binocular uncorrected-distance visual acuity(UDVA) of 20/20 or better, respectively. There were 48.7% of eyes that had the flat corneal meridian (minimum K) of 40.0 D or less. Although postoperative keratometry was a significant predictor of patient-reported satisfaction and the change in halo reports in the regression analysis, its relative contribution was very low and accounted for less than 0.50% of the variance explained by either model. Postoperative keratometry was not a significant predictor of a change in reports of glare, starburst, and ghosting or double vision. CONCLUSION: In this large cohort of patients, postoperative keratometry played a minimal and clinically insignificant role in predicting post-LASIK halo visual phenomena and patient-reported satisfaction. FINANCIAL DISCLOSURE: Dr. Schallhorn is a consultant to Abbott Medical Optics and Zeiss and a Global Medical Director for Optical Express. None of the other authors have a financial or proprietary interest in the products and materials presented in this paper.

The role of biostatistics in the quality improvement of refractive surgery.

PURPOSE: To demonstrate how the large quantity of uniformly collected data available to a corporate refractive surgery provider, Optical Express, is applied to drive improvements in patient outcomes. METHODS: Optical Express employs a skilled team of biostatisticians to analyze the information in its electronic medical records database of over 5,500,000 patient records. The techniques used to ensure high data quality and the selection of statistical methods used in making data-driven clinical decisions are described. The importance of appropriate statistical methods is demonstrated in an example in which the effect of age on refractive outcomes in low myopes is studied. The use of a corporate database in prospective and retrospective analyses is detailed. RESULTS: By providing the resources necessary to interpret the information in Optical Express' medical records database, the biostatistics department has helped Optical Express refine its procedures and improve surgical protocols and patient outcomes. CONCLUSIONS: Biostatistical analyses help transform the large quantities of uniformly collected clinical data available to a corporate surgery provider into information that can be applied to improve clinical practice. Such data-driven process improvements play a key role in improving patient outcomes.

Satisfaction of 13,655 patients with laser vision correction at 1 month after surgery.

PURPOSE: To assess the level of laser vision correction patient satisfaction achieved by a large corporate provider of refractive surgery. METHODS: A computer-based, interactive survey was used to query patients regarding their satisfaction with the services, experience, and results of their laser vision correction procedure. RESULTS: Responses from 13,655 consecutive patients who completed their 1-month postoperative examination were analyzed in this study. A very high level of satisfaction was observed both for the quality of postoperative care provided (98.6%) and for the visual results obtained (95.0%). Most patients (94.2%) indicated that the surgery improved their life, and most would recommend both laser vision correction (96.5%) and the corporate provider (97.5%) to friends and family. CONCLUSIONS: Patients report a high level of satisfaction with laser vision correction performed by a large corporate provider.

Femtosecond laser versus mechanical microkeratome: a retrospective comparison of visual outcomes at 3 months.

PURPOSE: To compare the visual outcomes of LASIK procedures in which flaps were created with a femtosecond laser (IntraLase FS 60Hz, Abbott Medical Optics [AMO]) to procedures in which flaps were created with a mechanical microkeratome (Moria Evo3 One Use-Plus, Moria SA). METHODS: A retrospective analysis was performed on 2000 eyes treated in 2008 for low myopia and astigmatism (sphere < -3.00 diopters [D]; cylinder < or = -0.75 D). The first 1000 consecutive eyes that had LASIK flaps created with a femtosecond laser were compared with the first 1000 consecutive eyes that had flaps created with a mechanical microkeratome. All eyes received wavefront-guided LASIK treatments performed with a VISX S4 IR Advanced CustomVue excimer laser (AMO). Refractive predictability, change in mean spherical equivalent refraction, postoperative uncorrected visual acuity (UCVA), and loss of best spectacle-corrected visual acuity (BSCVA) were compared at 1 day, 1 week, 1 month, and 3 months following surgery. RESULTS: The refractive accuracy was the same for both groups. At all time points measured, the percentage of eyes that achieved a postoperative UCVA of 20/20 or better was significantly higher in the femtosecond laser group than in the mechanical keratome group. Also, a higher percentage of eyes in the femtosecond laser group achieved a postoperative UCVA of 20/16 at 3 months. Finally, a lower percentage of eyes in the femtosecond laser group lost two or more lines of BSCVA at 1 week and 1 month postoperative. CONCLUSIONS: Creating LASIK flaps with the femtosecond laser resulted in faster visual recovery and better UCVA.

Effect of keratometry on visual outcomes 1 month after hyperopic LASIK.

PURPOSE: To determine whether preoperative, postoperative, or change in keratometry can be used to predict visual outcomes in hyperopic LASIK. METHODS: A retrospective analysis was conducted on hyperopic eyes treated at Optical Express clinics. All eyes were targeted for emmetropia and treated using wavefront-guided LASIK (VISX S4, Abbott Medical Optics [AMO]), with flaps created using a femtosecond laser (IntraLase FS-60 [AMO]). A total of 1659 consecutive eyes of 895 patients met the study inclusion criteria: preoperative sphere > or = 1.00 diopter, complete 1-month follow-up data, and availability of pre- and postoperative keratometry measurements. Factors associated with 1-month visual results were evaluated with multivariate analysis. RESULTS: Preoperative sphere was strongly correlated with visual outcomes. Higher levels of correction were associated with a greater loss of best spectacle-corrected visual acuity (BSCVA), a lower percentage of eyes achieving 20/20 BSCVA, and a lower percentage of eyes achieving 20/20 uncorrected visual acuity. For a given level of preoperative sphere, however, no statistically significant correlation was observed between visual outcomes and either pre- or postoperative keratometry. CONCLUSIONS: Preoperative, calculated postoperative, or 1-month postoperative keratometry values do not correlate with visual acuity outcomes following hyperopic LASIK.