Commercially Sponsored Section

ABSTRACT 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 refi ne 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 datadriven process improvements play a key role in improving patient outcomes. [J Refract Surg. 2009;25:S651-S654.] doi:10.3928/1081597X-20090611-05 W ith data on over 5,500,000 patients, the Optical Express clinical outcomes database has the potential to shed light on a wide range of medical and surgical questions. In addition to evaluating the performance of individual surgeons, this database is used to answer broad questions about the safety and effi cacy of various refractive surgery procedures and the factors infl uencing patient outcomes. Optical Express employs a biostatistics department that ensures the appropriateness of statistical methodology and the quality of data. By ensuring that the conclusions drawn from this data are statistically valid, the biostatistics department is essential to the company's effort to answer a range of questions about both the science and business of refractive surgery. ENHANCING OUTCOMES WITH DATA-DRIVEN DECISIONS The primary function of data analysis is to promote evidence-based decisions that improve patient care. By analyzing data from tens of thousands of patients, statistical models can be developed that identify the key factors that impact surgical outcomes. Surgeons can then use these models to modify treatment variables and improve patient outcomes. In addition to helping with the large-scale analyses reported in this supplement, the biostatistics department performs a variety of other assessments. For example, surgeon reviews are performed biannually to provide quality control information about each surgeon's performance. As part of these reviews, surgeons' performance is compared in a way that takes into account the patient population that each surgeon treats and the types of procedures he or she performs. Thus, the scoring system developed by the biostatistics department gives a valid "apples to apples" comparison. Finally, the biostatistics department responds to queries regarding the merits of anecdotal information. For example

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

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

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

PurposeTo compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE).MethodsA 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.ResultsThe 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.ConclusionRLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes

Prospective Evaluation of FIBROSpect II for Fibrosis Detection in Hepatitis C and B Patients Undergoing Laparoscopic Biopsy

Serum markers of liver fibrosis are difficult to validate, due to the sampling error and observer variability associated with percutaneous liver biopsies. Laparoscopic biopsy decreases sampling error and increases the reliability of histopathologic assessment. We prospectively evaluated the FIBROSpectSM II serum marker test for viral liver fibrosis against laparoscopic biopsies by studying 145 patients with chronic hepatitis B or C who underwent laparoscopy in a tertiary care setting. Serum samples obtained at biopsy were tested with FIBROSpect II to assess the degree of fibrosis. Multiple biopsies were obtained from each patient and scored blindly using the Batts-Ludwig system. An average biopsy stage was calculated and the performance of the test panel assessed. FIBROSpect II was able to rule in significant fibrosis (stages 2–4), with a likelihood ratio of 2.6. It correctly indicated absence of disease in 74% of stages 0–1 patients and correctly predicted significant disease in 67% of stages 2–4 patients. Test correlation was highest with Batts-Ludwig stages 3 (77%) and 4 (96%) and lowest with stage 2 (43%). Multiple biopsies from 52% of patients differed by at least 1 stage. In 13 patients (9%), cirrhosis was detected by laparoscopy but not histologically; in 4 (3%), a stage of 4 was obtained, but cirrhosis was not evident by laparoscopy. FIBROSpect II provided valuable additional information for assessing fibrosis. The discordance in fibrosis stage seen in multiple biopsies from the same patient underscores the need to consider all available information when assessing fibrosis. This study confirms and extends results of previous studies evaluating FIBROSpect II using percutaneous liver biopsy