Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).
Multicenter, ...randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea.
Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (> or =24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.
Best-corrected visual acuity and safety at 1 year.
The 1-year mean change (+/-standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9+/-11, P<0.001) and ranibizumab + deferred laser group (+9+/-12, P<0.001) but not in the triamcinolone + prompt laser group (+4+/-13, P=0.31) compared with the sham + prompt laser group (+3+/-13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes.
Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.
Current studies have reported that secondary students are highly engaged while playing mobile augmented reality (AR) learning games. Some researchers have posited that players' engagement may ...indicate a flow experience, but no research results have confirmed this hypothesis with vision‐based AR learning games. This study investigated factors related to students' engagement – as characterized by flow theory – during a collaborative AR, forensic science mystery game using mobile devices. School Scene Investigators: The Case of the Stolen Score Sheets is a vision‐based AR game played inside the school environment with Quick Response codes. A mixed methods approach was employed with 68 urban middle school students. Data sources included pre‐ and post‐surveys, field observations and group interviews. Results showed that neither gender nor interest in science was an important predictor of variability in flow experience. Gaming attitude uniquely predicted 23% of the variance in flow experience. Student flow experience features included a flash of intensity, a sense of discovery and the desire for higher performance. The findings demonstrated a potential for mobile AR science games to increase science interest and help students learn collaboration skills. Implications for future research concerning mobile AR science games are discussed.
Age-related macular degeneration (AMD) affects millions of people throughout the world. The intermediate stage may go undetected, as it typically is asymptomatic. However, the preferred practice ...patterns for AMD recommend identifying individuals with this stage of the disease to educate how to monitor for the early detection of the choroidal neovascular stage before substantial vision loss has occurred and to consider dietary supplements that might reduce the risk of the disease progressing from the intermediate to the advanced stage. Identification, though, can be time-intensive and requires expertly trained individuals.
To develop methods for automatically detecting AMD from fundus images using a novel application of deep learning methods to the automated assessment of these images and to leverage artificial intelligence advances.
Deep convolutional neural networks that are explicitly trained for performing automated AMD grading were compared with an alternate deep learning method that used transfer learning and universal features and with a trained clinical grader. Age-related macular degeneration automated detection was applied to a 2-class classification problem in which the task was to distinguish the disease-free/early stages from the referable intermediate/advanced stages. Using several experiments that entailed different data partitioning, the performance of the machine algorithms and human graders in evaluating over 130 000 images that were deidentified with respect to age, sex, and race/ethnicity from 4613 patients against a gold standard included in the National Institutes of Health Age-related Eye Disease Study data set was evaluated.
Accuracy, receiver operating characteristics and area under the curve, and kappa score.
The deep convolutional neural network method yielded accuracy (SD) that ranged between 88.4% (0.5%) and 91.6% (0.1%), the area under the receiver operating characteristic curve was between 0.94 and 0.96, and kappa coefficient (SD) between 0.764 (0.010) and 0.829 (0.003), which indicated a substantial agreement with the gold standard Age-related Eye Disease Study data set.
Applying a deep learning-based automated assessment of AMD from fundus images can produce results that are similar to human performance levels. This study demonstrates that automated algorithms could play a role that is independent of expert human graders in the current management of AMD and could address the costs of screening or monitoring, access to health care, and the assessment of novel treatments that address the development or progression of AMD.
The advent of computer graphic processing units, improvement in mathematical models and availability of big data has allowed artificial intelligence (AI) using machine learning (ML) and deep learning ...(DL) techniques to achieve robust performance for broad applications in social-media, the internet of things, the automotive industry and healthcare. DL systems in particular provide improved capability in image, speech and motion recognition as well as in natural language processing. In medicine, significant progress of AI and DL systems has been demonstrated in image-centric specialties such as radiology, dermatology, pathology and ophthalmology. New studies, including pre-registered prospective clinical trials, have shown DL systems are accurate and effective in detecting diabetic retinopathy (DR), glaucoma, age-related macular degeneration (AMD), retinopathy of prematurity, refractive error and in identifying cardiovascular risk factors and diseases, from digital fundus photographs. There is also increasing attention on the use of AI and DL systems in identifying disease features, progression and treatment response for retinal diseases such as neovascular AMD and diabetic macular edema using optical coherence tomography (OCT). Additionally, the application of ML to visual fields may be useful in detecting glaucoma progression. There are limited studies that incorporate clinical data including electronic health records, in AL and DL algorithms, and no prospective studies to demonstrate that AI and DL algorithms can predict the development of clinical eye disease. This article describes global eye disease burden, unmet needs and common conditions of public health importance for which AI and DL systems may be applicable. Technical and clinical aspects to build a DL system to address those needs, and the potential challenges for clinical adoption are discussed. AI, ML and DL will likely play a crucial role in clinical ophthalmology practice, with implications for screening, diagnosis and follow up of the major causes of vision impairment in the setting of ageing populations globally.
Intravitreal ranibizumab reduces the risk of visual acuity loss and increases the chance of visual acuity gain compared with no treatment or photodynamic therapy for selected cases of subfoveal ...choroidal neovascularization (CNV) in age-related macular degeneration (AMD). Although intravitreal ranibizumab did not result in substantial improvement (15 or more letters on an ETDRs chart) in the majority of cases treated in the MARINA (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab in the treatment of Neovascular AMD) or ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) trials, few cases experienced substantial visual acuity loss. The most serious known risk of treatment, endophthalmitis, although rare, is always a possibility. Intravitreal bevacizumab might be considered when ranibizumab is not available because of regulatory or financial constraints, and it might be considered in place of ranibizumab even without financial constraints if noninferiority trials show that bevacizumab is almost as good as-or is better than-ranibizumab. Systemic risks of intravitreal ranibizumab or bevacizumab are unknown, although trials have ruled out moderate or large systemic risks for ranibizumab. This therapy should be considered when initiating therapy for lesions that are subfoveal, and predominantly CNV when the lesion composition on fluorescein angiography (FA) is predominantly classic, or when there is presumed recent disease progression and the lesion composition is minimally classic or occult with no classic. Optical coherence tomography, FA, or both also might be of value to assist with decisions regarding continuation of treatment after it has been initiated. However, to date, there is little consistent information to suggest that utilizing these imaging modalities to consider withholding treatment before 2 years has been shown confidently to result in outcomes as good as monthly treatment. Extrapolation of these recommendations should be done with caution when considering the treatment of subfoveal CNV that is not predominantly CNV, such as predominantly blood lesions or lesions that are predominantly scar, as well as lesions associated with very low levels of visual acuity or those owing to causes other than AMD. A subsequent review in this series discusses other therapies for CNV being considered in the future.
To report expanded 2-year follow-up of a previously reported randomized trial evaluating intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid ...laser alone for treatment of diabetic macular edema (DME).
Multicenter, randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea.
Continuation of procedures previously reported for the randomized trial.
Best-corrected visual acuity and safety at the 2-year visit.
At the 2-year visit, compared with the sham + prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab + prompt laser group (95% confidence interval adjusted for multiple comparisons aCI, -0.4 to +7.7), 5.8 letters greater in the ranibizumab + deferred laser group (95% aCI, +1.9 to +9.8), and 1.5 letters worse in the triamcinolone + prompt laser group (95% aCI, -5.5 to +2.4). After the 1- to 2-year visit in the ranibizumab + prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group.
The expanded 2-year results reported are similar to results published previously and reinforce the conclusions originally reported: Ranibizumab should be considered for patients with DME and characteristics similar to those of the cohort in this clinical trial, including vision impairment with DME involving the center of the macula.
Abstract Background: When left untreated, age-related macular degeneration (AMD) is the leading cause of vision loss in people over fifty in the US. Currently it is estimated that about eight million ...US individuals have the intermediate stage of AMD that is often asymptomatic with regard to visual deficit. These individuals are at high risk for progressing to the advanced stage where the often treatable choroidal neovascular form of AMD can occur. Careful monitoring to detect the onset and prompt treatment of the neovascular form as well as dietary supplementation can reduce the risk of vision loss from AMD, therefore, preferred practice patterns recommend identifying individuals with the intermediate stage in a timely manner. Methods: Past automated retinal image analysis (ARIA) methods applied on fundus imagery have relied on engineered and hand-designed visual features. We instead detail the novel application of a machine learning approach using deep learning for the problem of ARIA and AMD analysis. We use transfer learning and universal features derived from deep convolutional neural networks (DCNN). We address clinically relevant 4-class, 3-class, and 2-class AMD severity classification problems. Results: Using 5664 color fundus images from the NIH AREDS dataset and DCNN universal features, we obtain values for accuracy for the (4-,3-,2-) class classification problem of (79.4%, 81.5%, 93.4%) for machine vs. (75.8%, 85.0%, 95.2%) for physician grading. Discussion: This study demonstrates the efficacy of machine grading based on deep universal features/transfer learning when applied to ARIA and is a promising step in providing a pre-screener to identify individuals with intermediate AMD and also as a tool that can facilitate identifying such individuals for clinical studies aimed at developing improved therapies. It also demonstrates comparable performance between computer and physician grading.
Diabetic macular edema (DME) is a leading cause of vision loss in persons with diabetes mellitus. Although there are national estimates for the prevalence of diabetic retinopathy and its risk factors ...among persons with diabetes, to our knowledge, no comparable estimates are available for DME specifically.
To estimate the prevalence of DME in the US population and to identify associated risk factors.
A cross-sectional analysis of 1038 participants aged 40 years or older with diabetes and valid fundus photographs in the 2005 to 2008 National Health and Nutrition Examination Survey.
The overall prevalence of DME and its prevalence according to age, race/ethnicity, and sex.
Of the 1038 persons with diabetes analyzed for this study, 55 had DME, for an overall weighted prevalence of 3.8% (95% CI, 2.7%-4.9%) or approximately 746, 000 persons in the US 2010 population aged 40 years or older. We identified no differences in the prevalence of DME by age or sex. Multivariable logistic regression analysis showed that the odds of having DME were higher for non-Hispanic blacks than for non-Hispanic whites (odds ratio OR, 2.64; 95% CI, 1.19-5.84; P = .02). Elevated levels of glycosylated hemoglobin A1c (OR, 1.47; 95% CI, 1.26-1.71 for each 1%; P < .001) and longer duration of diabetes (OR, 8.51; 95% CI, 3.70-19.54 for ≥ 10 vs <10 years; P < .001) were also associated with DME prevalence.
These results suggest a greater burden of DME among non-Hispanic blacks, individuals with high levels of hemoglobin A1c, and those with longer duration of diabetes. Given recent treatment advances in reducing vision loss and preserving vision in persons with DME, it is imperative that all persons with diabetes receive early screening; this recommendation is even more important for those at higher risk for DME.
Background
Given the growing interest in, and relevance of, integrated approaches to STEM (science, technology, engineering, and mathematics) education, there is an urgent desire to understand the ...challenges and obstacles to developing and implementing integrated STEM curricula and instruction. In this article, we present phase 1 of a two-phase needs assessment study to identify challenges and needs of promoting integrated approaches in STEM education. Utilizing a key informant approach, 22 K-12 teachers and four administrators selected as potential leaders in STEM education in an unidentified state on the East Coast of the USA were interviewed. Participants were asked to identify challenges and perceived supports to conduct integrated STEM education. Questions were open-ended in order to inform a larger, state-wide questionnaire study in phase 2 to be reported subsequently and were qualitatively coded.
Results
Several distinctive themes were identified as described by teacher participants when discussing challenges and obstacles of implementing integrated STEM education, as well as supports that would be most helpful in overcoming them. Participants also provided specific suggestions for teacher education needed to support integrated STEM education.
Conclusions
Preliminary findings suggest that many teachers are interested in integrated approaches to STEM, but do not believe they are well prepared to implement them. Teachers and administrators also suggest that adequate preparation in integrated STEM would entail a considerable rethinking and redesigning of pre-service courses and in-service workshops. Findings provide a starting point for better understanding teacher needs in integrated STEM and a springboard for further study.
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