An in vitro assessment of the thermoreversible PLGA-PEG-PLGA copolymer: Implications for Descemet's membrane endothelial keratoplasty.

BACKGROUND: To explore the use of a thermoreversible copolymer gel coating to prevent donor tissue scrolling in Descemet's membrane endothelial keratoplasty (DMEK). METHODS: PLGA-PEG-PLGA triblock copolymer was synthesised via ring opening polymerisation. Two formulations were fabricated and gelation properties characterised using rheological analyses. Endothelial cytotoxicity of the copolymer was assessed using a Trypan Blue exclusion assay. Thickness of the copolymer gel coating on the endothelial surface was analysed using anterior segment optical coherence tomography (OCT) (RTVue-100, Optovue Inc.). Gold nanoparticles were added to the copolymer to aid visualisation using OCT. Prevention of Descemet membrane donor scrolling was represented via a novel, in vitro, immersion of copolymer coated donor graft material. RESULTS: Two different formulations of PLGA-PEG-PLGA copolymer were successfully fabricated and the desired peak gelling temperature of 24°C was achieved by polymer blending. Application of 20%, 30% and 40% (wt/vol) polymer concentrations resulted in a statistically significant increase in polymer thickness on the endothelium (p < 0.001). There was no detectable endothelial cytotoxicity. The polymer was easy to apply to the endothelium and prevented scrolling of the DMEK graft. CONCLUSION: This PLGA-PEG-PLGA thermoreversible copolymer gel could be exploited as a therapeutic aid for preventing DMEK graft scrolling.

Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.

BACKGROUND: Phacoemulsification cataract surgery is usually performed in adults under local anaesthesia. Topical anaesthesia, which involves instilling anaesthetic drops to the ocular surface prior to and during surgery, has found large acceptance internationally. It is safe and allows for rapid patient turnover and visual recovery. Some surgeons have supplemented topical anaesthesia with intracameral lidocaine, reasoning that this may further reduce intraoperative pain, particularly during surgical stages involving manipulation of intraocular structures and rapid changes in fluid dynamics. This review, originally published in 2006 and updated in 2020, explores the efficacy and safety of using supplementary intracameral lidocaine in phacoemulsification cataract surgery. OBJECTIVES: To assess whether supplementing topical anaesthesia with intracameral lidocaine for phacoemulsification cataract surgery in adults reduces intraoperative and postoperative pain, and to assess differences in participant satisfaction, need for additional intraoperative anaesthesia, surgeon satisfaction, measures of intraocular toxicity, and adverse effects attributable to choice of anaesthesia. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS BIREME iAH, and six trial registries on 4 February 2020. We also searched the reference lists of identified studies. There were no language restrictions. SELECTION CRITERIA: We included only randomized controlled trials (RCTs) where participants underwent phacoemulsification for age-related cataract under topical anaesthesia with or without intracameral lidocaine either in two eyes of the same participant, or in different participants. We also included studies that used oral or intravenous sedation in addition to local anaesthesia. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial methodological quality using standard Cochrane procedures. MAIN RESULTS: We identified five new RCTs in this updated review. We included a total of 13 trials in the review, conducted in the UK, the USA, Australia, Italy, Canada, Taiwan, Singapore, India, and Pakistan, and comprising 2388 eyes of 2355 participants (one study was a paired-eye study with each participant acting as their own control). The age range of participants was 34 to 95 years. We excluded studies that only included low-risk participants and excluded more difficult operative cases, for example hard lens nuclei or small pupils. We excluded studies assessing only participants with Fuchs' endothelial dystrophy. We judged one study as at high risk for selection bias. We assessed five studies as having an unclear risk of bias for random sequence generation and seven studies an unclear risk of bias for allocation concealment. We judged three studies as at high risk of performance bias, as the surgeon was not blinded, and two studies as at unclear risk of bias for this domain. No studies were judged as at high risk for detection bias, but five studies were judged to have an unclear risk of bias for this domain. We judged all 13 included studies to have a low risk of attrition bias and an unclear risk of reporting bias. Data from eight RCTs favoured topical anaesthesia plus intracameral lidocaine 0.5% to 1% over topical anaesthesia alone for reducing intraoperative pain when measured using a 10-point visual analogue scale, analysed as a continuous outcome. Mean pain score was 0.26 lower in the supplemental intracameral lidocaine group (95% confidence interval (CI) -0.39 to -0.13, 1692 eyes, moderate-quality evidence). Data from seven RCTs favoured supplemental intracameral lidocaine for reducing intraoperative pain when measured as a dichotomous outcome. The odds ratio of experiencing any pain was 0.40 versus the topical anaesthesia-only group (95% CI 0.29 to 0.57, 1268 eyes, moderate-quality evidence). Data from four RCTs did not show any additional benefit on postoperative pain when measured using a 10-point visual analogue scale (mean difference 0.12 points, 95% CI -0.29 to 0.05, 751 eyes, moderate-quality evidence). The impact on participant satisfaction was uncertain as only one small study investigated this outcome. The study suggested no difference between groups (mean difference 0.1 points, 95% CI -0.47 to 0.27, 60 eyes, low-quality evidence). Data from seven RCTs did not demonstrate a difference between groups in the need for additional intraoperative anaesthesia (odds ratio 0.88, 95% CI 0.56 to 1.39, 1194 eyes of 1161 participants; low-quality evidence), although this result is uncertain. A variety of measures were reported relating to possible intraocular toxicity. Data from four RCTs did not demonstrate a difference between groups in mean percentage corneal endothelial cell count change from pre- to postoperatively (mean difference 0.89%, 95% CI -1.12% to 2.9%, 254 eyes of 221 participants, moderate-quality evidence). Synthesis of the evidence from eight RCTs identified no difference in intraoperative adverse events between groups (odds ratio 1.00, 95% CI 0.32 to 3.16, 1726 eyes, low-quality evidence). This result should be interpreted with caution, mainly due to a lack of clear definitions of adverse events, low numbers of events, heterogeneity between studies, and large confidence intervals. Large observational studies may have been more appropriate for looking at this outcome. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that supplementation of topical anaesthesia with intracameral lidocaine 0.5% to 1% for phacoemulsification cataract surgery in adults reduces participant perception of intraoperative pain. The odds of experiencing any pain (as opposed to no pain) were 60% less for the topical anaesthesia plus intracameral lidocaine group versus the topical anaesthesia-only group. However, the numerical amplitude of the effect may not be of great clinical significance on the continuous pain score scale. Generally, the pain scores were consistently low for both techniques. We found moderate-quality evidence that there is no additional benefit of intracameral lidocaine on postoperative pain. There is insufficient evidence to determine the impact on participant satisfaction and need for additional intraoperative anaesthesia due to low-quality evidence. There is moderate-quality evidence that intracameral lidocaine supplementation does not increase measures of intraocular toxicity, specifically loss of corneal endothelial cells. There is low-quality evidence that the incidence of intraoperative adverse events is unchanged with intracameral lidocaine supplementation, but as RCTs are not the optimum medium for looking at this, this result should be interpreted with caution. Further research specifically investigating the adverse effects of intracameral anaesthesia might help to better determine its safety profile. Economic evaluations would also be useful for detailing cost implications.

Comparison of postoperative refractive outcome in eyes undergoing combined phacovitrectomy vs cataract surgery following vitrectomy.

BACKGROUND: To investigate the accuracy of preoperative biometry in eyes undergoing combined phacovitrectomy and to compare it with eyes having cataract surgery at a later point in time following vitrectomy. METHODS: Patients with epiretinal membrane or macular hole who underwent combined phacovitrectomy (group 1) or phacoemulsification following pars plana vitrectomy (PPV) (group 2) were included in this retrospective, comparative, interventional case series. The primary outcome measures were the intraocular lens power prediction error (PE) and the percentage of eyes with PE > ± 0.5D in the two groups. Secondary outcome measures included the correlation between epidemiological, clinical, or surgical factors and dioptric shift. In addition, the influence of optical coherence tomography characteristics to the PE was investigated. RESULTS: Group 1 and 2 consisted of 55 and 54 eyes, respectively, for a total of 109 eyes included in the study. The mean absolute PE was 0.59 D (range + 1.4 to - 2.5D) in group 1 and 0.35 (range + 1.0 to - 1.45D) in group 2 (p = 0.01). PE greater than 0.5D was observed in 47% of eyes in group 1 as opposed to 16.6% of eyes in group 2 (p = 0.027). The PE was associated with shallower anterior chamber depth (ACD), increased central macular thickness (> 300 µ), and worse baseline best-corrected visual acuity. Photoreceptor ellipsoid zone or external limiting membrane disruption was not associated with significantly greater postoperative refractive deviations. CONCLUSION: Combined phacovitrectomy may result in greater postoperative refractive prediction error compared to phacoemulsification alone following vitrectomy. Patients with worse vision, greater central macular thickness, and shallow anterior chambers require more caution since they are prone to inaccurate preoperative biometry.

Paracentesis as valve re-bubbling technique for Descemet's membrane endothelial keratoplasty (DMEK) graft detachment.

INTRODUCTION: We present a variation in the slit-lamp microscope re-bubbling technique for DMEK detachment in which a paracentesis is used as a self-sealing valve. METHODS: Of twenty-eight consecutive DMEK cases, five (18%) required re-bubbling. A 20-gauge side port blade was used to make a paracentesis in the inferior temporal quadrant. A 30-gauge cannula mounted on a 3 ml syringe was employed to inject air using the paracentesis as a valve allowing better control over intraocular pressure and percentage anterior chamber air fill. RESULTS: Graft re-attachment was achieved in all cases. One case required two re-bubbling procedures. There were no cases of pupil block glaucoma or other complications. CONCLUSION: Slit-lamp re-bubbling is a practical and safe alternative to taking patients back to the operating room. Using a new paracentesis for valve action control over air injection with a blunt cannula adds better control and may help to reduce complications.

Keratoconus Natural Progression: A Systematic Review and Meta-analysis of 11 529 Eyes.

PURPOSE: We set out to describe the natural history of keratoconus. We included untreated patients, and our key outcome measures were vision, refraction, and corneal curvature. CLINICAL RELEVANCE: Keratoconus affects 86 in 100 000 people, causing visual loss due to increasing irregular corneal astigmatism, and the quality of life declines in patients. Interventions are used to stabilize the disease or improve vision, including corneal cross-linking (CXL) and grafting, but these carry risks. Detailed knowledge of the natural history of keratoconus is fundamental in making informed decisions on when their benefits outweigh these risks. METHODS: We included prospective or retrospective studies of pediatric or adult patients who reported 1 or more of visual acuity, refraction, and corneal curvature measures: steep keratometry (K2), mean keratometry (Kmean), or maximum keratometry (Kmax), thinnest pachymetry, corneal transplantation rates, corneal scarring incidence, and patient-reported outcome measures (PROMs). Databases analyzed included Medline, Embase, CENTRAL, and CINAHL. Searches were carried out until October 2018. Bias assessment was carried out using the Joanna Briggs Institute model of evidence-based healthcare. RESULTS: Our search yielded 3950 publication titles, of which 41 were included in our systematic review and 23 were incorporated into the meta-analysis. Younger patients and those with greater Kmax demonstrated more steepening of Kmax at 12 months. The meta-analysis for Kmax demonstrated a significant increase in Kmax of 0.7 diopters (D) at 12 months (95% confidence interval [CI], 0.31-1.14; P = 0.003). Our meta-regression model predicted that patients had 0.8 D less Kmax steepening over 12 months for every 10-year increase in age (P = 0.01). Patients were predicted to have 1 D greater Kmax steepening for every 5 D of greater baseline Kmax (P = 0.003). At 12 months, there was a significant increase in the average Kmean of 0.4 D (95% CI, 0.18-0.65; P = 0.004). CONCLUSIONS: We report the first systematic review and meta-analysis of keratoconus natural history data including 11 529 eyes. Younger patients and those with Kmax steeper than 55 D at presentation have a significantly greater risk of progression of keratoconus. Closer follow-up and a lower threshold for cross-linking should be adopted in patients younger than 17 years and steeper than 55 D Kmax.

Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial.

INTRODUCTION: Vaginal laxity is a highly prevalent and undertreated medical condition. AIM: To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial. METHODS: The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained. Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm2] vs Sham [1 J/cm2], respectively) delivered to the vaginal tissue. MAIN OUTCOME MEASURES: The primary efficacy outcome was the proportion of randomized subjects reporting "no vaginal laxity" (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R). RESULTS: No vaginal laxity was achieved by 43.5% and 19.6% (P = .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 (P = .031) and -2.42 (P = .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively. CONCLUSION: The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel non-surgical therapy for vaginal laxity, a prevalent and undertreated condition.

Quality of vision after bilateral multifocal intraocular lens implantation: a randomized trial--AT LISA 809M versus AcrySof ReSTOR SN6AD1.

PURPOSE: To compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the AT LISA 809M (Carl Zeiss Meditec, Jena, Germany) versus the AcrySof ReSTOR SN6AD1 (Alcon Laboratories, Irvine, CA) multifocal intraocular lens (IOL). DESIGN: Double-masked, prospective, randomized, controlled clinical trial. PARTICIPANTS: A total of 188 patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange. METHODS: Patients were preoperatively randomized (allocation ratio 1:1) to bilateral implantation with the AT LISA 809M IOL or ReSTOR SN6AD1 IOL. Postoperative outcomes were assessed 4 to 8 months after second eye surgery. MAIN OUTCOME MEASURES: The primary outcome was visual symptoms evaluated with the Quality of Vision (QoV) questionnaire. Secondary outcomes included other questionnaire data (CatQuest-9SF, spectacle independence, vision satisfaction, and dysphotopsia) and visual function measures (near, intermediate, and distance visual acuity, binocular reading speed [International Reading Speed Texts], contrast sensitivity, and forward light scatter). Adverse events, including intraoperative and postoperative complications, also were evaluated. RESULTS: There was no significant difference between IOL groups in Rasch-adjusted QoV scores for frequency (P = 0.95), severity (P = 0.56), and bothersomeness (P = 0.34) of visual symptoms; median (interquartile) scores for these QoV subscales were 29 (15-37), 22 (13-27), and 14 (0-29) for the AT LISA 809M IOL group, respectively, and 32 (15-37), 22 (13-30), and 14 (0-29) for the ReSTOR SN6AD1 IOL group, respectively. Halo was the most prominent dysphotopsia symptom, with 6% in both IOL groups reporting halo symptoms as very bothersome. Complete spectacle independence was achieved in 69 of 84 (82.1%) AT LISA 809M recipients and 66 of 85 (77.6%) ReSTOR SN6AD1 recipients (P = 0.57). Preferred reading distance was slightly nearer for the AT LISA 809M IOL. There were no statistically significant differences in any of the other secondary outcome measures. CONCLUSIONS: Visual symptoms were similar after bilateral implantation of the AT LISA 809M and ReSTOR SN6AD1 IOLs. Both these diffractive bifocal IOLs produce high levels of spectacle independence and patient satisfaction. However, a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results 4 to 8 months after surgery.

Altered phenotype and function of NK cells infiltrating human papillomavirus (HPV)-associated genital warts during HIV infection.

HIV-infected individuals experience more persistent HPV infections and are less likely to resolve genital warts. This study compared phenotype and functions of NK and T cells from genital warts and blood from 67 women. We compared in vitro functional responses of NK and T cells by multiparametric flow cytometry. HIV+ women had significantly lower frequencies of CD4 T cells in warts (p = 0.001) and blood (p = 0.001). While the distribution of NK cell subsets was similar, HIV+ women tended to have lower frequencies of CD56(Dim) NK cells in both blood (p = 0.0001) and warts (p = 0.006) than HIV- women. Wart NK cells from HIV+ women expressed significantly lower CD107a and produced IFN-γ. HAART status was not associated with differences in NK cell functionality. We conclude that wart NK cells from HIV+ women have defects in their ability to degranulate and/or secrete IFN-γ, which may provide insights into why HIV+ women fail to spontaneously resolve genital warts.

Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia.

BACKGROUND: Myopia is a condition in which the focusing power (refraction) of the eye is greater than that required for clear distance vision. There are two main types of surgical correction for moderate to high myopia; excimer laser and phakic intraocular lenses (IOLs). Excimer laser refractive surgery for myopia works by removing corneal stroma to lessen the refractive power of the cornea and to bring the image of a viewed object into focus onto the retina rather than in front of it. Phakic IOLs for the treatment of myopia work by diverging light rays so that the image of a viewed object is brought into focus onto the retina rather than in front of the retina. They can be placed either in the anterior chamber of the eye in front of the iris or in the posterior chamber of the eye between the iris and the natural lens. OBJECTIVES: To compare excimer laser refractive surgery and phakic IOLs for the correction of moderate to high myopia by evaluating postoperative uncorrected visual acuity, refractive outcome, potential loss of best spectacle corrected visual acuity (BSCVA) and the incidence of adverse outcomes. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to February 2014), EMBASE (January 1980 to February 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 11 February 2014. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing excimer laser refractive surgery and phakic IOLs for the correction of myopia greater than 6.0 diopters (D) spherical equivalent. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We performed data analysis. We summarised data for outcomes using odds ratios. We used a fixed-effect model as only three trials were included in the review. MAIN RESULTS: This review included three RCTs with a total of 228 eyes. The range of myopia of included patients was -6.0 D to -20.0 D of myopia with up to 4.0 D of myopic astigmatism. The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 or better at 12 months postoperative was not significantly different between the two groups. Phakic IOL surgery was safer than excimer laser surgical correction for moderate to high myopia as it results in significantly less loss of best spectacle corrected visual acuity (BSCVA) at 12 months postoperatively. However there is a low risk of developing early cataract with phakic IOLs. Phakic IOL surgery appears to result in better contrast sensitivity than excimer laser correction for moderate to high myopia. Phakic IOL surgery also scored more highly on patient satisfaction/preference questionnaires. AUTHORS' CONCLUSIONS: The results of this review suggest that, at one year post surgery, phakic IOLs are safer than excimer laser surgical correction for moderate to high myopia in the range of -6.0 to -20.0 D and phakic IOLs are preferred by patients. While phakic IOLs might be accepted clinical practice for higher levels of myopia (greater than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism), it may be worth considering phakic IOL treatment over excimer laser correction for more moderate levels of myopia (less than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism). Further RCTs adequately powered for subgroup analysis are necessary to further elucidate the ideal range of myopia for phakic IOLs. This data should be considered alongside comparative data addressing long-term safety as it emerges.

Accommodative intraocular lens versus standard monofocal intraocular lens implantation in cataract surgery.

BACKGROUND: Following cataract surgery and intraocular lens (IOL) implantation, loss of accommodation or postoperative presbyopia occurs and remains a challenge. Standard monofocal IOLs correct only distance vision; patients require spectacles for near vision. Accommodative IOLs have been designed to overcome loss of accommodation after cataract surgery. OBJECTIVES: To define (a) the extent to which accommodative IOLs improve unaided near visual function, in comparison with monofocal IOLs; (b) the extent of compromise to unaided distance visual acuity; c) whether a higher rate of additional complications is associated the use of accommodative IOLs. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 9), Ovid MEDLINE, Ovid MEDLINE in-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily Update, Ovid OLDMEDLINE (January 1946 to October 2013), EMBASE (January 1980 to October 2013), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrial.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 10 October 2013. SELECTION CRITERIA: We include randomised controlled trials (RCTs) which compared implantation of accommodative IOLs to implantation of monofocal IOLs in cataract surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results, assessed risk of bias and extracted data. All included trials used the 1CU accommodative IOL (HumanOptics, Erlangen, Germany) for their intervention group. One trial had an additional arm with the AT-45 Crystalens accommodative IOL (Eyeonics Vision). We performed a separate analysis comparing 1CU and AT-45 IOL. MAIN RESULTS: We included four RCTs, including 229 participants (256 eyes), conducted in Germany, Italy and the UK. The age range of participants was 21 to 87 years. All studies included people who had bilateral cataracts with no pre-existing ocular pathologies. We judged all studies to be at high risk of performance bias. We graded two studies with high risk of detection bias and one study with high risk of selection bias.Participants who received the accommodative IOLs achieved better distance-corrected near visual acuity (DCNVA) at six months (mean difference (MD) -3.10 Jaeger units; 95% confidence intervals (CI) -3.36 to -2.83, 2 studies, 106 people, 136 eyes, moderate quality evidence). Better DCNVA was seen in the accommodative lens group at 12 to 18 months in the three trials that reported this time point but considerable heterogeneity of effect was seen, ranging from 1.3 (95% CI 0.98 to 1.68; 20 people, 40 eyes) to 6 (95% CI 4.15 to 7.85; 51 people, 51 eyes) Jaeger units and 0.12 (95% CI 0.05 to 0.19; 40 people, binocular) logMAR improvement (low quality evidence). The relative effect of the lenses on corrected distant visual acuity (CDVA) was less certain. At six months there was a standardised mean difference of -0.04 standard deviations (95% CI -0.37 to 0.30, 2 studies, 106 people, 136 eyes, low quality evidence). At long-term follow-up there was heterogeneity of effect with 18-month data in two studies showing that CDVA was better in the monofocal group (MD 0.12 logMAR; 95% CI 0.07 to 0.16, 2 studies, 70 people,100 eyes) and one study which reported data at 12 months finding similar CDVA in the two groups (-0.02 logMAR units, 95% CI -0.06 to 0.02, 51 people) (low quality evidence).The relative effect of the lenses on reading speed and spectacle independence was uncertain, The average reading speed was 11.6 words per minute more in the accommodative lens group but the 95% confidence intervals ranged from 12.2 words less to 35.4 words more (1 study, 40 people, low quality evidence). People with accommodative lenses were more likely to be spectacle-independent but the estimate was very uncertain (risk ratio (RR) 8.18; 95% CI 0.47 to 142.62, 1 study, 40 people, very low quality evidence).More cases of posterior capsule opacification (PCO) were seen in accommodative lenses but the effect of the lenses on PCO was uncertain (Peto odds ratio (OR) 2.12; 95% CI 0.45 to 10.02, 91 people, 2 studies, low quality evidence). People in the accommodative lens group were more likely to require laser capsulotomy (Peto OR 7.96; 95% CI 2.49 to 25.45, 2 studies, 60 people, 80 eyes, low quality evidence). Glare was reported less frequently with accommodative lenses but the relative effect of the lenses on glare was uncertain (RR any glare 0.78; 95% CI 0.32 to 1.90, 1 study, 40 people, and RR moderate/severe glare 0.45; 95% CI 0.04 to 4.60, low quality evidence). AUTHORS' CONCLUSIONS: There is moderate-quality evidence that study participants who received accommodative IOLs had a small gain in near visual acuity after six months. There is some evidence that distance visual acuity with accommodative lenses may be worse after 12 months but due to low quality of evidence and heterogeneity of effect, the evidence for this is not clear-cut. People receiving accommodative lenses had more PCO which may be associated with poorer distance vision. However, the effect of the lenses on PCO was uncertain.Further research is required to improve the understanding of how accommodative IOLs may affect near visual function, and whether they provide any durable gains. Additional trials, with longer follow-up, comparing different accommodative IOLs, multifocal IOLs and monofocal IOLs, would help map out their relative efficacy, and associated late complications. Research is needed on control over capsular fibrosis postimplantation.Risks of bias, heterogeneity of outcome measures and study designs used, and the dominance of one design of accommodative lens in existing trials (the HumanOptics 1CU) mean that these results should be interpreted with caution. They may not be applicable to other accommodative IOL designs.

A global review of publicly available image datasets for the anterior segment of the eye.

ABSTRACT: This study comprehensively reviewed publicly available image datasets for the anterior segment, with a focus on cataract, refractive, and corneal surgery. The goal was to assess characteristics of existing datasets and identify areas for improvement. PubMED and Google searches were performed using the search terms "refractive surgery", "anterior segment", "cornea", "corneal", "cataract" AND "database", with the related word of "imaging". Results of each of these searches were collated, identifying 26 publicly available anterior segment image datasets. Imaging modalities included optical coherence tomography, photography and confocal microscopy. Most data sets were small, 80% originated in the USA, China, or Europe. Over 50% of images were from normal eyes. Disease states represented included keratoconus, corneal ulcers, and Fuchs' dystrophy. Most datasets were incompletely described. To promote accessibility going forwards to 2030, the ESCRS Digital Health Special Interest Group will annually update a list of available image datasets for anterior segment at www.escrs.org.

A comparison of keratoconus progression following collagen cross-linkage using standard or personalised keratometry thresholds.

OBJECTIVE: To define how estimates of keratoconus progression following collagen cross-linking (CXL) vary according to the parameter selected to measure corneal shape. MATERIALS AND METHODS: We estimated progression following CXL in 1677 eyes. We compared standard definitions of keratoconus progression based on published thresholds for Kmax, front K2, or back K2, or progression of any two of these three parameters, with the option of an increased threshold for Kmax values ≥ 55D. As corneal thickness reduces unpredictably after CXL, it was excluded from the principal analysis. We then repeated the analysis using novel adaptive estimates of progression for Kmax, front K2, or back K2, developed separately using 6463 paired readings from keratoconus eyes, with a variation of the Bland-Altman method to determine the 95% regression-based limits of agreement (LoA). We created Kaplan-Meier survival plots for both standard and adaptive thresholds. The primary outcome was progression five years after a baseline visit 9-15 months following CXL. RESULTS: Progression rates were 8% with a standard (≥ 1.5D) threshold for K2 or 6% with the static multi-parameter definition. With a ≥ 1D threshold for Kmax, the progression was significantly higher at 29%. With adaptive Kmax or K2, the progression rates were similar (20%) but less than with the adaptive multi-parameter method (22%). CONCLUSIONS: Estimates of keratoconus progression following CXL vary widely according to the reference criteria. Using adaptive thresholds (LoA) to define the repeatability of keratometry gives estimates for progression that are markedly higher than with the standard multi-parameter method.

Suboptimal visual outcome after femto-LASIK ablation in a high myopic patient.

A 28-year-old nurse had an aberration-free femto-laser in situ keratomileusis (LASIK) performed for her myopia of -6.25 -0.50 × 096 and -6.75 -0.50 × 175 in the right and left eye, respectively. Corrected distance visual acuity (CDVA) preoperatively was 20/16. Preoperatively, there were no abnormalities on Scheimpflug imaging, and a pachymetry of 585 µm was measured in both eyes. Flap thickness was 115 µm. The patient was quite nervous during the surgery. Since the surgery, her uncorrected distance visual acuity (UDVA) and CDVA are suboptimal at 20/30 and 20/20 in the right eye, and 20/20 and 20/16 in the left eye. 3 months postoperatively, there is a stable manifest refraction of +0.25 -1.25 × 030 and +0.25 -0.00 × 0. The keratometric astigmatism in the Scheimpflug imaging is 1.2 diopter (D) × 114 and 0.4 D × 78 in the right and left eyes, respectively (FIgures 1 and 2). Thinnest pachymetry is 505 µm and 464 µm in the right and left eye, respectively. Her wavefront analysis shows refraction in a 6 mm zone of -0.99 -1.22 × 32 and -0.91 -0.36 × 136. The cycloplegic refraction is 1.25 -1.00 × 023 and +1.00 -0.25 × 006 (Figures 3 and 4). What is the cause of the suboptimal visual outcome in this case? What would be your treatment strategy to improve visual outcome?

Randomized trial of multifocal intraocular lenses versus monovision after bilateral cataract surgery.

OBJECTIVE: To compare spectacle independence in patients randomized to receive bilateral multifocal intraocular lenses (IOLs) or monofocal IOLs with the powers adjusted to produce monovision. DESIGN: Randomized, multicenter clinical trial. PARTICIPANTS: A total of 212 patients with bilateral, visually significant cataract. METHODS: Before bilateral sequential cataract surgery, patients were randomized (allocation ratio 1:1) to receive bilateral Tecnis ZM900 diffractive multifocal lenses (Abbott Medical Optics, Santa Ana, CA) or Akreos AO monofocal lenses (Bausch & Lomb, Rochester, NY) with the powers adjusted to target -1.25 diopters (D) monovision. Outcomes were assessed 4 months after the second eye underwent operation. MAIN OUTCOME MEASURES: The primary outcome was spectacle independence. Secondary outcomes included questionnaires (VF-11R, dysphotopsia symptoms, and satisfaction) and visual function measures (near, intermediate, and distance logarithm of minimum angle of resolution [logMAR] visual acuity, stereoacuity, contrast sensitivity, and forward light scatter). RESULTS: A total of 212 patients were randomized, and 187 patients (88%) returned for assessment 4 months after surgery. Uniocular distance refractions in the monovision arm showed a mean spherical equivalent of +0.075 D in the distance eye and -0.923 in the near eye. In the multifocal arm, the mean distance spherical equivalents were -0.279 D and -0.174 D in the right and left eyes, respectively. A total of 24 of 93 patients (25.8%) in the monovision arm and 67 of 94 patients (71.3%) in the multifocal arm reported never wearing glasses (P<0.001, Fisher exact test). The adjusted odds ratio of being spectacle free was 7.51 (95% confidence interval, 3.89-14.47). Binocular uncorrected acuities did not differ significantly for distance (0.058 logMAR for monovision vs. 0.076 for multifocal, P = 0.3774) but were significantly worse in the multifocal arm for intermediate acuity (0.149 vs. 0.221, P = 0.0001) and in the monovision arm for near acuity (0.013 vs. -0.025, P = 0.037). In the first postoperative year, 6 patients (5.7%) in the multifocal arm underwent IOL exchange (4 had a bilateral and 2 had a unilateral exchange). No patients in the monovision arm underwent IOL exchange. CONCLUSIONS: Patients randomized to bilateral implantation with the diffractive multifocal Tecnis ZM900 were more likely to report being spectacle independent but also more likely to undergo IOL exchange than those randomized to receive monofocal implants (Akreos AO) with the powers adjusted to give low monovision.

Laser-assisted in-situ keratomileusis (LASIK) versus photorefractive keratectomy (PRK) for myopia.

BACKGROUND: Myopia (also known as short-sightedness or near-sightedness) is an ocular condition in which the refractive power of the eye is greater than is required, resulting in light from distant objects being focused in front of the retina instead of directly on it. The two most commonly used surgical techniques to permanently correct myopia are photorefractive keratectomy (PRK) and laser-assisted in-situ keratomileusis (LASIK). OBJECTIVES: To compare the effectiveness and safety of LASIK and PRK for correction of myopia by examining post-treatment uncorrected visual acuity, refractive outcome, loss of best spectacle-corrected visual acuity, pain scores, flap complications in LASIK, subepithelial haze, adverse events, quality of life indices and higher order aberrations. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 11), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2012), EMBASE (January 1980 to November 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to November 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 November 2012. We also searched the reference lists of the studies and the Science Citation Index. SELECTION CRITERIA: We included randomised controlled trials comparing LASIK and PRK for the correction of any degree of myopia. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We summarised data using the odds ratio and mean difference. We combined odds ratios using a random-effects model after testing for heterogeneity. MAIN RESULTS: We included 13 trials (1135 participants, 1923 eyes) in this review. Nine of these trials randomised eyes to treatment, two trials randomised people to treatment and treated both eyes, and two trials randomised people to treatment and treated one eye. None of the paired trials reported an appropriate paired analysis. We considered the overall quality of evidence to be low for most outcomes because of the risk of bias in the included trials. There was evidence that LASIK gives a faster visual recovery than PRK and is a less painful technique. Results at one year after surgery were comparable: most analyses favoured LASIK but they were not statistically significant. AUTHORS' CONCLUSIONS: LASIK gives a faster visual recovery and is a less painful technique than PRK. The two techniques appear to give similar outcomes one year after surgery. Further trials using contemporary techniques are required to determine whether LASIK and PRK as currently practised are equally safe. Randomising eyes to treatment is an efficient design, but only if analysed properly. In future trials, more efforts could be made to mask the assessment of outcome.

Alterations in Carbohydrate Quantities in Freeze-Dried, Relative to Fresh or Frozen Maize Leaf Disks.

For various reasons, leaves are occasionally lyophilized prior to storage at -80 °C and preparing extracts. Soluble carbohydrate identity and quantity from maize leaf disks were ascertained in two separate years using anion exchange HPLC with pulsed electrochemical detection. Analyses were made from disks after freezing in liquid nitrogen with or without subsequent lyophilization (both years) or directly after removal from plants with or without lyophilization (only in the second year). By adding the lyophilizing step, galactose content consistently increased and, frequently, so did galactoglycerols. The source of the galactose increase with the added lyophilizing step was not due to metabolizing raffinose, as the raffinose synthase (rafs) null mutant leaves, which do not make that trisaccharide, also had a similar increase in galactose content with lyophilization. Apparently, the ester linkages attaching free fatty acids to galactoglycerolipids of the chloroplast are particularly sensitive to cleavage during lyophilization, resulting in increases in galactoglycerols. Regardless of the galactose source, a systematic error is introduced for carbohydrate (and, most likely, also chloroplast mono- or digalactosyldiacylglycerol) amounts when maize leaf samples are lyophilized prior to extraction. The recognition of lyophilization as a source of galactose increase provides a cautionary note for investigators of soluble carbohydrates.

Recommendation for Presbyopia-Correcting Intraocular Lenses: A Delphi Consensus Statement by the ESASO Study Group.

PURPOSE: To establish consensus among experts in lens and refractive surgery to guide general ophthalmologists on issues related to presbyopia-correcting intraocular lenses (IOLs). DESIGN: A modified Delphi method to reach a consensus among experts. METHODS: A steering committee formulated 105 relevant items grouped into four sections (preoperative considerations, IOL selection, intraoperative considerations, and postoperative considerations). The consensus was defined as ≥ 70% of experts agreeing with the evaluation of a statement. RESULTS: Ten experts participated and completed all rounds of questionnaires (100% response rate). Of 68 items considered in the preoperative considerations, consensus was achieved in 48 (70.6%). There was a lack of consensus over IOL selection, the experts only agreed on the importance of the patient's habits for the optical IOL design selection. Of the 14 considerations related to intraoperative issues, the experts reached a consensus on 10 (71.4%). The postoperative considerations section reached the highest consensus in 10 items of 13 (76.9%). CONCLUSIONS: Key recommendations for a diffractive multifocal IOL were a potential postoperative visual acuity > 0.5, a keratometry between 40-45 diopters, a pupil >2.8 mm under photopic conditions and <6.0 mm under scotopic conditions, a root mean square of higher order corneal aberrations <0.5 µm for 6-mm pupil size, while monofocal or non-diffractive IOLs should be considered for patients with coexisting eye disorders. A lack of agreement was found in the issues related to the IOL selection.

Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia.

BACKGROUND: Myopia is a condition in which the focusing power (refraction) of the eye is greater than that required for clear distance vision. There are two main types of surgical correction for moderate to high myopia; excimer laser and phakic intraocular lenses (IOLs). Excimer laser refractive surgery for myopia works by removing corneal stroma to lessen the refractive power of the cornea and to bring the image of a viewed object into focus onto the retina rather than in front of it. Phakic IOLs for the treatment of myopia work by diverging light rays so that the image of a viewed object is brought into focus onto the retina rather than in front of the retina. They can be placed either in the anterior chamber of the eye in front of the iris or in the posterior chamber of the eye between the iris and the natural lens. OBJECTIVES: The aim of this review is to compare the effect of excimer laser refractive surgery versus phakic IOLs for the correction of moderate to high myopia. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 11), MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to November 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 28 November 2011. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing excimer laser refractive surgery and phakic IOLs for the correction of myopia greater than 6.0 diopters (D) spherical equivalent. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We performed data analysis. We summarised data for outcomes using odds ratios. We used a fixed-effect model as only three trials were included in the review. MAIN RESULTS: This review included three RCTs with a total of 228 eyes. The range of myopia of included patients was -6.0 D to -20.0 D of myopia with up to 4.0 D of myopic astigmatism. The percentage of eyes with uncorrected visual acuity (UCVA) of 20/20 or better at 12 months postoperative was not significantly different between the two groups. Phakic IOL surgery was safer than excimer laser surgical correction for moderate to high myopia as it results in significantly less loss of best spectacle corrected visual acuity (BSCVA) at 12 months postoperatively. However there is a low risk of developing early cataract with phakic IOLs. Phakic IOL surgery appears to result in better contrast sensitivity than excimer laser correction for moderate to high myopia. Phakic IOL surgery also scored more highly on patient satisfaction/preference questionnaires. AUTHORS' CONCLUSIONS: The results of this review suggest that phakic IOLs are safer than excimer laser surgical correction for moderate to high myopia in the range of -6.0 to -20.0 D and phakic IOLs are preferred by patients. While phakic IOLs might be accepted clinical practice for higher levels of myopia (greater than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism), it may be worth considering phakic IOL treatment over excimer laser correction for more moderate levels of myopia (less than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism). Further RCTs adequately powered for subgroup analysis are necessary to further elucidate the ideal range of myopia for phakic IOLs.

Identification of Late Embryogenesis Abundant (LEA) protein putative interactors using phage display.

Arabidopsis thaliana seeds without functional SEED MATURATION PROTEIN1 (SMP1), a boiling soluble protein predicted to be of intrinsic disorder, presumed to be a LATE EMBRYOGENESIS ABUNDANT (LEA) family protein based on sequence homology, do not enter secondary dormancy after 3 days at 40 °C. We hypothesized that SMP1 may protect a heat labile protein involved in the promotion of secondary dormancy. Recombinant SMP1 and GmPM28, its soybean (Glycine max), LEA4 homologue, protected the labile GLUCOSE-6-PHOSPHATE DEHYROGENASE enzyme from heat stress, as did a known protectant, Bovine Serum Albumin, whether the LEA protein was in solution or attached to the bottom of microtiter plates. Maintenance of a biological function for both recombinant LEA proteins when immobilized encouraged a biopanning approach to screen for potential protein interactors. Phage display with two Arabidopsis seed, T7 phage, cDNA libraries, normalized for transcripts present in the mature, dehydrated, 12-, 24-, or 36-h imbibed seeds, were used in biopans against recombinant SMP1 and GmPM28. Phage titer increased considerably over four rounds of biopanning for both LEA proteins, but not for BSA, at both 25 and at 41 °C, regardless of the library used. The prevalence of multiple, independent clones encoding portions of specific proteins repeatedly retrieved from different libraries, temperatures and baits, provides evidence suggesting these LEA proteins are discriminating which proteins they protect, a novel finding. The identification of putative LEA-interacting proteins provides targets for reverse genetic approaches to further dissect the induction of secondary dormancy in seeds in response to heat stress.

The Vision Correction Questionnaire: an electronic patient-reported outcome measure for refractive surgery.

PURPOSE: To develop a psychometrically robust electronic patient reported outcome measure (ePROM) for refractive surgery. SETTING: Moorfields Eye Hospital, London, United Kingdom. DESIGN: Questionnaire development study. METHODS: Items were derived in 6 domains (spectacle dependence, visual quality, eye comfort, functional freedom, emotional wellbeing, and satisfaction with treatment) from existing Rasch adjusted instruments, patient and surgeon feedback, and refinement in semistructured interviews before administration to a field test cohort (n = 360) of patients undergoing routine refractive surgery. Spectacle dependence and satisfaction with treatment items were used to provide descriptive statistical information only. Contemporary criteria for item reduction and Rasch modeling were applied to the remaining domains. The finalized questionnaire was then administered to a second patient cohort (n = 120) before and after surgery to assess sensitivity to change. RESULTS: A 5-item scale derived for emotional wellbeing was unidimensional and a good fit to the Rasch model with ordered category response profiles, adequate precision (person separation 2.22 logits, reliability coefficient 0.83), and no misfitting items. Mean logit scores were 0.91 higher after treatment (effect size 1.26) suggesting a positive impact on emotional wellbeing. Functional scales could not be derived for visual quality, eye comfort, or functional freedom. Single-item ratings for visual quality and eye comfort were retained in our final 11-item questionnaire. CONCLUSIONS: This short ePROM should integrate well with routine clinical care and clinical trials in refractive surgery. The Rasch adjusted emotional wellbeing scale may help quantify the way patients feel about refractive surgery, with the remaining items providing useful descriptive information.