Comparative Analysis of Clinical and Patient-Reported Outcomes of a New Enhanced Monofocal IOL and a Conventional Monofocal IOL

Steven J Dell,1 Stephen J Hannan,2 Jan A Venter,2 David Teenan,2 Noelle C Hannan,2 Dasi Raju,2 Colin W Berry,2 Huba J Kiss,2 Julie M Schallhorn3,4 1Dell Laser Consultants, Austin, TX, USA; 2Optical Express, Glasgow, UK; 3University of California, San Francisco, Department of Ophthalmology, San Francisco, CA, USA; 4F.I. Proctor Foundation, University of California, San Francisco, CA, USACorrespondence: Steven J Dell, Dell Laser Consultants, 901 Mopac Expressway South, Barton Oaks Plaza IV, Suite 350, Austin, TX, 78746, USA, Email [email protected]: To compare the outcomes of the Tecnis Eyhance ICB00 IOL, designed to enhance intermediate vision, to a conventional Tecnis Monofocal ZCB00 IOL.Methods: This retrospective analysis compared two cohorts of patients undergoing lens replacement surgery with bilateral implantation of the Tecnis ICB00 or the Tecnis ZCB00 IOL (383 patients in each group). Monocular and binocular uncorrected distance (UDVA), intermediate (UIVA; 66cm), and near (UNVA; 40cm) visual acuities, refractive predictability, and patient-reported outcomes were compared. A sub-analysis of patients with the Eyhance IOL was performed to compare patients who achieved bilateral emmetropia to those with mini-monovision. One-month postoperative outcomes were analyzed.Results: Both groups had comparable UDVA outcomes. On average, both monocular and binocular UIVAs were approximately one Snellen line better in patients implanted with Eyhance IOL (monocular UIVA: ICB00 0.23 ± 0.18 logMAR, ZCB00 0.33 ± 0.19 logMAR; binocular UIVA: ICB00 0.18 ± 0.18 logMAR, ZCB00 0.26 ± 0.20 logMAR, p < 0.01). Likewise, the mean UNVA was also one Snellen line better with the ICB00 model (monocular UNVA: ICB00 0.51 ± 0.20 logMAR, ZCB00 0.61 ± 0.18 logMAR; binocular UNVA: ICB00 0.42 ± 0.19 logMAR, ZCB00 0.51 ± 0.22 logMAR, p < 0.01). There was no difference between the two groups in overall satisfaction or visual phenomena. A subgroup of patients who achieved mini-monovision with Eyhance IOL had, on average, one Snellen line better UIVA and UNVA compared to patients with bilateral emmetropia.Conclusion: Patients receiving the enhanced monofocal IOL had better intermediate and near vision compared to those receiving the conventional monofocal IOL, with similar levels of patient-reported photic phenomena in both groups.Keywords: enhanced monofocal IOL, Eyhance, patient-reported outcome

Immediate Sequential Bilateral Cataract Surgery in Patients with Bilateral Visually Significant Cataracts

Dasi Raju,1 Stephen J Hannan,1 Mirna Belovari,1 Noelle C Hannan,1 Colin W Berry,1 Jan A Venter,1 David Teenan,1 Steven C Schallhorn,2,3 Julie M Schallhorn2,4 1Optical Express, Glasgow, UK; 2Department of Ophthalmology, University of California, San Francisco, CA, USA; 3Carl Zeiss Meditec, Inc, Dublin, CA, USA; 4F.I. Proctor Foundation, University of California, San Francisco, CA, USACorrespondence: Dasi Raju, Clinical Services Department, Optical Express, 200 Street Vincent Street, Glasgow, G2 5SG, UK, Email [email protected]: To report our experience of performing immediate sequential bilateral cataract surgery (ISBCS) in patients with visually significant cataracts and reduced preoperative corrected distance visual acuity (CDVA).Methods: Data of patients who underwent ISBCS for visually significant cataracts and had preoperative CDVA ≤ 20/32 (≤ 0.2 logMAR) in each eye were retrospectively reviewed. Refractive and visual outcomes were evaluated for the last available postoperative visit. Intraoperative and serious postoperative adverse events occurring within the first three months of surgery were reviewed.Results: A total of 1335 patients (2670 eyes) were included in the analysis, with a mean age of 71.9 ± 9.5 years. On the last visit, 50.2% and 89.1% of eyes achieved uncorrected distance visual acuity (UDVA) ≥ 20/20 (0.0 logMAR) and ≥ 20/32 (0.2 logMAR), respectively. Of all eyes, 83.8% were within ± 0.50D, and 96.4% were within ± 1.00 D of emmetropia. Ten patients had postoperative bilateral ametropia of more than 1.00D in each eye, but eight of them still achieved binocular UDVA ≥ 20/40. Intraoperative events occurred in 14 eyes of 13 patients (per-eye incidence: 0.524% or 1 in 191 eyes). A total of 86 postoperative adverse events occurred in 80 eyes of 53 patients (per-eye incidence 2.996% or 1 in 33 eyes), of which cystoid macular edema was the most common. Only three eyes had CDVA reduced by more than two Snellen lines compared to preoperative CDVA, two of which were not related to cataract surgery. There was no patient with bilateral CDVA loss.Conclusion: In our cohort of patients with visually significant cataracts, ISBCS resulted in good refractive predictability and a low incidence of serious adverse events.Keywords: immediate sequential bilateral cataract surgery, visual outcomes, refractive outcomes, adverse event

Kidney single-cell atlas reveals myeloid heterogeneity in progression and regression of kidney disease

Background Little is known about the roles of myeloid cell subsets in kidney injury and in the limited ability of the organ to repair itself. Characterizing these cells based only on surface markers using flow cytometry might not provide a full phenotypic picture. Defining these cells at the single-cell, transcriptomic level could reveal myeloid heterogeneity in the progression and regression of kidney disease. Methods Integrated droplet– and plate-based single-cell RNA sequencing were used in the murine, reversible, unilateral ureteric obstruction model to dissect the transcriptomic landscape at the single-cell level during renal injury and the resolution of fibrosis. Paired blood exchange tracked the fate of monocytes recruited to the injured kidney. Results A single-cell atlas of the kidney generated using transcriptomics revealed marked changes in the proportion and gene expression of renal cell types during injury and repair. Conventional flow cytometry markers would not have identified the 12 myeloid cell subsets. Monocytes recruited to the kidney early after injury rapidly adopt a proinflammatory, profibrotic phenotype that expresses Arg1, before transitioning to become Ccr21 macrophages that accumulate in late injury. Conversely, a novel Mmp121 macrophage subset acts during repair. Conclusions Complementary technologies identified novel myeloid subtypes, based on transcriptomics in single cells, that represent therapeutic targets to inhibit progression or promote regression of kidney disease

Coronary CT Angiography and 5-Year Risk of Myocardial Infarction.

BACKGROUND: Although coronary computed tomographic angiography (CTA) improves diagnostic certainty in the assessment of patients with stable chest pain, its effect on 5-year clinical outcomes is unknown. METHODS: In an open-label, multicenter, parallel-group trial, we randomly assigned 4146 patients with stable chest pain who had been referred to a cardiology clinic for evaluation to standard care plus CTA (2073 patients) or to standard care alone (2073 patients). Investigations, treatments, and clinical outcomes were assessed over 3 to 7 years of follow-up. The primary end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years. RESULTS: The median duration of follow-up was 4.8 years, which yielded 20,254 patient-years of follow-up. The 5-year rate of the primary end point was lower in the CTA group than in the standard-care group (2.3% [48 patients] vs. 3.9% [81 patients]; hazard ratio, 0.59; 95% confidence interval [CI], 0.41 to 0.84; P=0.004). Although the rates of invasive coronary angiography and coronary revascularization were higher in the CTA group than in the standard-care group in the first few months of follow-up, overall rates were similar at 5 years: invasive coronary angiography was performed in 491 patients in the CTA group and in 502 patients in the standard-care group (hazard ratio, 1.00; 95% CI, 0.88 to 1.13), and coronary revascularization was performed in 279 patients in the CTA group and in 267 in the standard-care group (hazard ratio, 1.07; 95% CI, 0.91 to 1.27). However, more preventive therapies were initiated in patients in the CTA group (odds ratio, 1.40; 95% CI, 1.19 to 1.65), as were more antianginal therapies (odds ratio, 1.27; 95% CI, 1.05 to 1.54). There were no significant between-group differences in the rates of cardiovascular or noncardiovascular deaths or deaths from any cause. CONCLUSIONS: In this trial, the use of CTA in addition to standard care in patients with stable chest pain resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years than standard care alone, without resulting in a significantly higher rate of coronary angiography or coronary revascularization. (Funded by the Scottish Government Chief Scientist Office and others; SCOT-HEART ClinicalTrials.gov number, NCT01149590 .)

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.

Role of the treating surgeon in the consent process for elective refractive surgery

Steven C Schallhorn,1&ndash;3 Stephen J Hannan,3 David Teenan,3 Julie M Schallhorn1 1Department of Ophthalmology, University of California, San Francisco, San Francisco, 2Roski Eye Institute, University of Southern California, Los Angeles, CA, USA; 3Optical Express, Glasgow, UK Purpose: To compare patient&rsquo;s perception of consent quality, clinical and quality-of-life outcomes after laser vision correction (LVC) and refractive lens exchange (RLE) between patients who met their treating surgeon prior to the day of surgery (PDOS) or on the day of surgery (DOS). Design: Retrospective, comparative case series. Setting: Optical Express, Glasgow, UK. Methods: Patients treated between October 2015 and June 2016 (3972 LVC and 979 RLE patients) who attended 1-day and 1-month postoperative aftercare and answered a questionnaire were included in this study. All patients had a thorough preoperative discussion with an optometrist, watched a video consent, and were provided with written information. Patients then had a verbal discussion with their treating surgeon either PDOS or on the DOS, according to patient preference. Preoperative and 1-month postoperative visual acuity, refraction, preoperative, 1-day and 1-month postoperative questionnaire were compared between DOS and PDOS patients. Multivariate regression model was developed to find factors associated with patient&rsquo;s perception of consent quality. Results: Preoperatively, 8.0% of LVC and 17.1% of RLE patients elected to meet their surgeon ahead of the surgery day. In the LVC group, 97.5% of DOS and 97.2% of PDOS patients indicated they were properly consented for surgery (P=0.77). In the RLE group, 97.0% of DOS and 97.0% of PDOS patients stated their consent process for surgery was adequate (P=0.98). There was no statistically significant difference between DOS and PDOS patients in most of the postoperative clinical or questionnaire outcomes. Factors predictive of patient&rsquo;s satisfaction with consent quality were postoperative satisfaction with vision (46.7% of explained variance), difficulties with night driving, close-up vision or outdoor/sports activities (25.4%), visual phenomena (12.2%), dry eyes (7.5%), and patient&rsquo;s satisfaction with surgeon&rsquo;s care (8.2%). Conclusion: Perception of quality of consent was comparable between patients that elected to meet the surgeon PDOS, and those who did not. Keywords: consent process, refractive surgery, laser vision correction, refractive lens exchange, quality of life outcome

Monovision LASIK in emmetropic presbyopic patients

Michelle Y Peng,1 Stephen Hannan,2 David Teenan,2 Steven J Schallhorn,1,3 Julie M Schallhorn1,4 1Department of Ophthalmology, University of California, San Francisco, CA, USA; 2Optical Express, Glasgow, UK; 3Carl Zeiss Meditec, CA, USA; 4F.I. Proctor Foundation, University of California, San Francisco, CA, USA Background: To evaluate the efficacy and patient satisfaction of laser in situ keratomileusis (LASIK) monovision correction in presbyopic emmetropic patients.Methods: A retrospective review of 294 patients who underwent LASIK for monovision was conducted. All patients had preoperative uncorrected distance visual acuity in each eye of 20/25 or better in both eyes and underwent primary LASIK treatment in one eye with a near target; 82 patients underwent surgery in the distant eye for hypermetropia. Patients completed a patient-reported-outcome questionnaire at their one-month postoperative visit. Analysis was performed on a per patient basis with a logistic regression model.Results: Patients achieved a postoperative mean spherical equivalent of -0.05 diopters (D) in the distant eye and -1.92 D in the near eye. Prior to surgery, 64.7% (n=178) of patients reported they were satisfied or very satisfied with their vision; postoperatively, this increased to 85.4% (n=251). The greatest predictor of dissatisfaction after surgery was severe patient-reported visual phenomena (glare, halos, starbursts, ghosting) (odds ratio 1.18, P=0.001).Conclusions: LASIK monovision for presbyopic patients with low refractive error and good preoperative uncorrected distance visual acuity is both safe and effective with high patient satisfaction. Patients who were dissatisfied in the postoperative period tended to be those with postoperative visual symptoms. Keywords: monovision, LASIK, presbyopia, refractive surger

Informed consent in refractive surgery: in-person vs telemedicine approach

Steven C Schallhorn,1&ndash;3 Stephen J Hannan,2 David Teenan,2 Martina Pelouskova,2 Julie M Schallhorn1,4 1Department of Ophthalmology, University of California, San Francisco, CA, USA; 2Optical Express, Glasgow, UK; 3Carl Zeiss Meditec, Dublin, CA, USA; 4F.I. Proctor Foundation, University of California, San Francisco, CA, USA Purpose: The aim of this study was to compare the quality of consent process in refractive surgery between patients who had a preoperative consent discussion with the surgeon using a telemedicine approach and those who had a face-to-face discussion.Methods: Patients treated between January and December 2017 (8,184 laser vision correction [LVC] and 3,754 refractive lens exchange [RLE] patients) that attended day 1 and 1-month postoperative visit were retrospectively reviewed. Preoperative consent preparation included a consultation with an optometrist, observation of an educational video, and written information. Patients then selected either a face-to-face appointment with their surgeon (in-clinic group) or a telemedicine appointment (remote group) for their consent discussion, according to their preference. Patient experience questionnaire and clinical data were included in a multivariate model to explore factors associated with consent quality.Results: Prior to surgery, 80.1% of LVC and 47.9% of RLE patients selected remote consent. Of all LVC patients, 97.5% of in-clinic and 98.3% of remote patients responded that they were adequately consented for surgery (P=0.04). Similar percentages in the RLE group were 97.6% for in-clinic and 97.9% for remote patients (P=0.47). In a multivariate model, the major predictor of patient&rsquo;s satisfaction with the consent process was postoperative satisfaction with visual acuity, responsible for 80.4% of variance explained by the model. Other significant contributors were postoperative visual phenomena and dry eyes, difficulty with night driving, close-up and distance vision, postoperative uncorrected distance visual acuity, change in corrected distance visual acuity, and satisfaction with the surgeon&rsquo;s approach. The type of consent (remote or in-clinic) had no impact on patient&rsquo;s perception of consent quality in the regression model.Conclusion: The majority of patients opted for telemedicine-assisted consent. Those who chose it were equally satisfied as those who had a face-to-face meeting with their surgeon. Dissatisfaction with surgical outcome was the major factor affecting patient&rsquo;s perception of consent quality, regardless of the method of their consent. Keywords: informed consent, telemedicine, refractive surgery, LASIK, photorefractive keratectomy, refractive lens&nbsp;exchange&nbsp

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

Stephen J Hannan,1 David Teenan,1 Jan A Venter,1 Keith A Hettinger,1 Colin W Berry,1 Noelle C Hannan,1 Huba J Kiss,1 Dasi Raju,1 Julie M Schallhorn2,3 1Optical Express, Glasgow, United Kingdom; 2University of California, San Francisco, Department of Ophthalmology, San Francisco, CA, USA; 3F.I. Proctor Foundation, University of California, San Francisco, San Francisco, CA, USACorrespondence: Stephen J Hannan, Clinical Services Department, Optical Express, 200 St Vincent St, Glasgow, G2 5SG, United Kingdom, Tel +44 7740592389, Email [email protected]: 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.Keywords: wavefront-guided LASIK, myopia, aberrometer, refractive outcomes, patient-reported outcome

Outcomes of excimer laser enhancements in pseudophakic patients with multifocal intraocular&nbsp;lens

Steven C Schallhorn,1&ndash;3 Jan A Venter,2 David Teenan,2 Julie M Schallhorn,3 Keith A Hettinger,2 Stephen J Hannan,2 Martina Pelouskova2 1Department of Ophthalmology, University of California, San Francisco, CA, USA; 2Optical Express, Glasgow, UK; 3Department of Ophthalmology, University of Southern California, Los Angeles, CA, USA 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&plusmn;4.4&nbsp;months. Manifest spherical equivalent changed from -0.02&plusmn;0.83&nbsp;D (-3.38&nbsp;D to +2.25&nbsp;D) pre-enhancement to 0.00&plusmn;0.34&nbsp;D (-1.38&nbsp;D to +1.25&nbsp;D) post-enhancement. At the last follow-up, the percentage of eyes within 0.50&nbsp;D and 1.00&nbsp;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&plusmn;0.06 logMAR [logarithm of the minimum angle of resolution]) and after LVC procedure (-0.04&plusmn;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. Keywords: excimer laser enhancements, pseudophakic patients, multifocal IO