Dr. Pravin Dugel[/caption]
Pravin U. Dugel, MD
Retina Consultants of Arizona
Phoenix, Arizona; USC Roski Eye Institute
Keck School of Medicine
University of Southern California
Los Angeles, California
MedicalResearch.com: What is the background for this study?
Response: OASIS is an acronym for “OcriplASmIn for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole”. It was a Phase IIIB, randomized, prospective, sham-controlled, double-masked, multicenter clinical study. The goal of the study was to further evaluate the long-term (24 months) efficacy and safety of a single injection of 0.125mg of ocriplasmin in patients with symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT), including macular hole (MH).
OASIS evaluated 220 patients with symptomatic VMA/VMT. One hundred forty-six patients received ocriplasmin while 74 served as a sham control group. In the latter group, no intravitreal injection was administered.
Dr. Aleksandra Rachitskaya[/caption]
Aleksandra Rachitskaya, MD
Assistant Professor of Ophthalmology
Retina Service, Department of Ophthalmology
Cole Eye Institute
Cleveland, OH 44195
MedicalResearch.com: What is the background for this study?
Response: The Centers for Medicare and Medicaid Services (CMS) Open Payments database lists payment records from drug and device manufacturers to physicians. Anti-vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab (Lucentis®, Genentech, Inc., San Francisco, CA), aflibercept (Eylea™, Regeneron, Tarrytown, NY) and off-label bevacizumab (Avastin®, Genentech, Inc., San Francisco, CA) are used for a variety of indications in ophthalmology.
The current study examined the payments made to ophthalmologists related to ranibizumab and aflibercept and correlated those payments to provider usage of these medications. The former was achieved by utilizing Centers for Medicare and Medicaid Services (CMS) Provider Utilization and Payment database.
Dr. Daria Van Tyne[/caption]
Dr. Daria Van Tyne, PhD
The Gilmore Lab
Department of Ophthalmology
Harvard Medical School
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A specific clone of E. coli, type ST131, which produces an extended-spectrum beta-lactamase (ESBL – an enzyme that inactivates many penicillin-type antibiotics), has rapidly spread around the globe to become the leading cause of multidrug-resistant, non-intestinal E. coli infection. Despite this, E. coli is a rare cause of infection of the cornea. A patient was recently seen at the Massachusetts Eye and Ear Infirmary with a severe E. coli infection of the cornea, and the large number of antibiotic resistances of this strain tipped us off to the possibility that it might be the highly virulent ST131 ESBL type. By sequencing the DNA of its genome, we found that it was indeed ST131 ESBL E. coli. Moreover, we discovered a new mutation in this strain that allows it to produce a slimy outer coating on its surface. This slime layer, or capsule, makes the bacteria more resistant to removal by phagocytic cells of the immune system. The slime layer also makes these particular colonies appear different on a special type of agar that contains the dye Congo Red.
Dr. Cecelia Lee[/caption]
Cecilia S. Lee, MD
Department of Ophthalmology
University of Washington School of Medicine
Seattle, WA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Access to eye care is a critical issue currently in the United States. With the expected increase in the aging US population, many eye diseases are age-related and there is an expected associated increase in demand for eye care. Prior studies have estimated access to care in many different ways including looking at providers per zipcode, utilization of billing codes, and distance to provider. We sought to estimate the access to eye care providers using a much more accurate way to estimate the driving distance to provider. Specifically, we recreated a driving route system similar to Google Maps or Apple Maps for navigation to plot direct driving routes.
Dr. Heather Sheardown[/caption]
Heather Sheardown PhD PEng FCAE
Scientific Director 20/20 NSERC Ophthalmic Materials Network
Professor, Department of Chemical Engineering
Canada Research Chair in Ophthalmic Biomaterials
McMaster University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Putting drops in the eye is well accepted from the standpoint of practitioners but is problematic for many patients. Therefore, particularly in cases where multiple drops are required in a day such as is the case with certain infections for example or a lifetime of drops is required such as is the case with diseases like glaucoma, patient compliance is a real issue. In addition, as much as 95% of any drop instilled in the eye is lost within the first 5 minutes, meaning that drug concentrations within the drop need to be higher to ensure that the required dose gets into the patient’s eye.
Therefore there is a real need for a better alternative to traditional eyedrops is needed. We have developed a new method of formulating drugs for delivery as drops that adhere to the mucous layer of the tear film, allowing for smaller amounts of drug to be delivered over a prolonged period of time. This means that fewer drops with lower drug concentrations can be delivered. This is a micelle based system that allows for the formulation of more hydrophobic drugs. A mucoadhesive component associated with the micelle binds to the mucin layer of the tears, meaning that the residence time on the eye is similar to that of this layer - between 4 and 7 days. Drug is slowly released from the micelle, allowing for prolonged treatment.
Dr. Jennifer Cope[/caption]
Dr. Jennifer Cope MD, MPH
Medical Epidemiologist
CDC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Approximately 41 million people in the United States wear contact lenses, a safe and effective form of vision correction if worn and cared for as directed. Contact lenses are medical devices that are regulated by the Food and Drug Administration (FDA). Adverse events related to contact lenses are reported to FDA’s Medical Device Report (MDR) database.
During 2005–2015, a total of 1,075 Medical Device Reports describing contact lens–related corneal infections were reported to the FDA Medical Device Report database. Approximately 20% of these reports described a patient who suffered serious eye damage. More than 25% of the 1,075 reports described modifiable behaviors that might have put the patient at risk for a contact lens–related corneal infection, such as sleeping in lenses or wearing lenses longer than for the prescribed period.
Dr. Rong Kung-Tsai[/caption]
Rong-Kung Tsai MD, PhD
Professor and Director
Institute of Eye Research
Buddhist Tzu Chi Medical Center;
Director, Institute of Medical Sciences
Tzu Chi University, Hualien, Taiwan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Non-arteritic anterior ischemic optic neuropathy (NAION) is pathogenetically different from stroke, stroke is caused by thromboembolism. However, they share many (but not all) systemic vascular risk factors. Previous small scale studies got controversial results. Using the National Health Insurance Research Database (NHIRD) in Taiwan to conduct the cohort study, 414 patients were included in the NAION group and 789 in the control group (base one million beneficiaries). The incidence of NAION is 3.72/100,000 person-years in Taiwan, and patients with NAION have more chances to develop ischemic stroke (p=0.003), but not hemorrhage stroke.
The subgroup analyses further showed the risk of ischemic stroke among the subjects with NAION and with comorbidities was 3.35 times higher than those without NAION. However, in patients with NAION but no comorbidities, there is no increase risk of stroke development.
Dr. R. Sterling Haring[/caption]
MedicalResearch.com Interview with:
R. Sterling Haring, DO, MPH
Center for Healthcare Quality and Patient Safety
University of Lugano, Switzerland
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Chemical burns of the eye are among the most serious and emergent of eye injuries. In the worst cases, corrosive chemicals can eat into the eye and damage internal structures, rendering the individual with little or no vision in the affected eye. Given the proximity of the eyes to one another, it is not uncommon for these injuries to be bilateral, further complicating the clinical picture.
Working-age individuals, particularly men, are known to be a high-risk group for these types of injuries. In the first nationwide study on this issue, we found that 1-year old infants were at substantially higher (1.5x) risk of these injuries than the highest-risk age group among adults; 2-year-olds were a close second. These injuries tapered off as children grew older, such that the risk among 1-year-old infants was 13 times higher than that of 7-year-old children. Across all ages, injuries occurred most frequently among lower-income households.
Dr. Paul Loprinzi[/caption]
Paul Dinneen Loprinzi, PhD
Health, Exercise Science and Recreation Management
University of Mississippi
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Previous research demonstrates that adults who have higher daily sedentary behavior tend to have worse cardiometabolic health profiles. The extent to which sedentary behavior is associated with diabetic retinopathy has yet to be evaluated in the literature before our study. Our findings provided some suggestive evidence that more sedentary behavior was associated with a higher odds of having diabetic retinopathy.
Dr. Marianne Price,[/caption]
Marianne Price, Ph.D.
Executive Director
Cornea Research Foundation of America
Indianapolis, Indiana
MedicalResearch.com: What is the background for this study?
Dr. Price: Over 40% of Americans are near-sighted and the rate of near-sightedness continues to increase. The most common treatments are glasses, contact lenses, or laser refractive surgery (LASIK).
The purpose of this study was to find how patient satisfaction compares with contact lenses and with LASIK. We enrolled 1800 participants at 20 sites across the USA; 694 participants (39%) continued wearing contact lenses and 1106 (61%) had LASIK. Participants were surveyed at baseline, 1, 2 and 3 years.
Dr. Jeffrey Willis[/caption]
Jeffrey R. Willis, MD, PhD
University of California Davis Eye Center
Sacramento, CA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The goal of this study was to understand how "Big Data" in ophthalmology could be utilized to assess the prevalence of rare diseases such as myopic choroidal neovascularization (mCNV).
Prior to our study, there was limited knowledge on the burden of this devastating condition as previous estimates were done more than 20 years ago, had a small sample size, and were not generalizable to the current U.S. population. In order to address this knowledge gap, we realized the potential of two large datasets with ophthalmic information, including the National Health and Nutrition Examination Survey (NHANES) and the IRIS Registry. The former provides nationally representative data, but with limited ophthalmic disease information. The latter dataset, supported by the American Academy of Ophthalmology (AAO), is the nation's only comprehensive database of ophthalmic patient outcomes. By triangulating data from the these two data sources in conjunction with population estimates from the U.S. Census Bureau, we were able to calculate the mCNV prevalence in the United States. Specifically, we showed that mCNV is a rare condition, affecting about 41,000 adult Americans, with a higher burden on women than men. This study effectively showed that using "Big Data" in ophthalmology could help us better understand the epidemiology of rare ophthalmic conditions in the US.
Adam Glassman[/caption]
MedicalResearch.com Interview with:
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Diabetic macular edema (DME) is the most common cause of vision loss in patients with diabetes, impairing the vision of approximately 750,000 people in the United States. The most common treatment involves the injection into the eye of one of 3 drugs that inhibit vascular endothelial growth factor (VEGF). The Diabetic Retinopathy Clinical Research Network, funded by the National Institutes of Health, conducted a randomized clinical trial on the comparative effectiveness of the 3 anti-VEGF drugs EYLEA®, Avastin®, or Lucentis® for eyes with decreased vision from diabetic macular edema. There are substantial cost differences between the three drugs. In the United States, EYLEA® costs approximately $1850, repackaged (compounded) Avastin® $60, and Lucentis® $1170 per injection. In eyes with relatively good starting vision, there were no differences in vision outcomes; all three groups, on average, had improved vision. In eyes with starting vision of 20/50 or worse, EYLEA® had better vision outcomes at 1 year than either Avastin® or Lucentis®, and better vision outcomes at 2 years than Avastin®. However, given that, on average, eyes will receive 9 to 10 injections within the first year of treatment and 5 injections in the second year, neither EYLEA® nor Lucentis® would be considered cost effective by standard benchmarks compared with Avastin® unless their prices decrease substantially.
MedicalResearch.com Interview with: [caption id="attachment_24454" align="alignleft" width="185"] Dr. Rohit Varma[/caption] Rohit Varma, MD, MPH, USC Interim Dean, Keck School of Medicine Professor and Chair, Department of Ophthalmology Director, USC Gayle and Edward Roski Eye Institute President, USC Care Los Angeles, CA 90033 MedicalResearch.com: What is the background for this study? Dr. Varma: In a study funded by the National Eye...
Sheldon j. .J.Kwok[/caption]
Sheldon J.J. Kwok
MD/PhD Candidate
Harvard-MIT Health Sciences and Technology | Harvard Medical School
Yun Bio-Optics Lab
Wellman Center for Photomedicine
MGH
MedicalResearch.com: What is the background for this study?
Response: Corneal collagen crosslinking (CXL) using UV light and riboflavin has become a popular and effective technique for treating corneal ectatic disorders, such as keratoconus, by mechanically strengthening the corneal stroma. We were interested in enhancing the capabilities of CXL using the principle of two-photon excitation, which uses a femtosecond laser to confine crosslinking to only where the laser is focused. By scanning the laser, this allows us to crosslink any arbitrary three-dimensional region deep inside tissue.
With two-photon collagen crosslinking (2P-CXL), treatment of thin corneas is possible without affecting the underlying endothelium. Irradiation can also be patterned to improve keratocyte viability. Furthermore, selective crosslinking in three dimensions offers the possibility of modulating corneal curvature for refractive error correction.
Dr. Hans Hoerauf[/caption]
Prof. Dr. med. Hans Hoerauf
Direktor der Augenklinik
Universitätsmedizin Göttingen
Göttingen
MedicalResearch.com: What is the background for this study?
Dr. Hoerauf: Two treatment options, anti-vascular endothelial growth factors (anti-VEGFs) and corticosteroids, with different mechanisms of action are available for the treatment of macular edema secondary to Central Retinal Vein Occlusion (CRVO). Our study, COMRADE-C, is the first head-to-head study to investigate the clinical efficacy and safety of the European labels of ranibizumab (anti-VEGF) versus dexamethasone intravitreal implant (corticosteroid) in patients with CRVO over six months.
Dr. T. Dianne Langford[/caption]
Dr. T. Dianne Langford PhD
Associate Professor, Neuroscience and Neurovirology
Lewis Katz School of Medicine
Temple University
MedicalResearch.com: What is the background for this study?
Dr. Langford: The ocular-motor system has been shown to reflect neural damage, and one of ocular-motor functions, near point of convergence (NPC), was reported to worsen after a sport-related concussion (Mucha et al. Am J Sport Med). But the effects of subconcussive head impact, a milder form of head injury in the absence of outward symptoms remains unknown. Prior to this study, we found that in a controlled soccer heading experimental paradigm decreased NPC function, and even 24h after the headings, NPC was not normalized back to baseline (Kawata et al. 2016 Int J Sport Med). To extend our findings from the human laboratory study, we launched longitudinal clinical studies in collaboration with the Temple football team, to see if repetitive exposure to subconcussive head impacts negatively affects NPC.
Dr. Brian Boxer Wachler[/caption]
Dr. Brian Boxer Wachler MD
Boxer Wachler Vision Institute
Beverly Hills, California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As an eye surgeon, I observed patients tended to have more age spots on the left side of their faces. I was examining a patient with Keratoconus and after I noted her age spots on her left cheeks, I began to look into this phenomenon. It turns out there are many studies that found more skin cancer on the left side of the face compared to the right side of the face. In Australia (where people drive on the left side of the road) it’s the opposite – more skin cancer on the right side of the face. Our study found that cars on average have significantly lower UVA (ultraviolet A) protection in the side windows compared to windshields which have universally high UVA protection. I believe this can be the missing link that can explain higher rates of skin cancer on the side of the face by the driver’s window. There are also more cataracts in left eyes vs right eyes. There was no relationship between high-end cars and low-end cars for side window UV protection – in other words many more pricey cars had just as poor side window UV protection as less expensive cars.
Dr. J. William Harbour[/caption]
Dr. Chris Hammond[/caption]
Christopher J. Hammond, MD, FRCOphth
Departments of Ophthalmology & Twin Research
King's College London
St. Thomas' Hospital
London UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Hammond: Twin studies allow us to quantify the influence of genes vs environment on a trait and this study suggests 65% of variation of cataract progression is due to environmental factors.
Vitamin C has long been linked to cataract because the lens of the eye is bathed in fluid rich in ascorbate, a derivative of vitamin C. We showed that, even in a relatively well-nourished UK population, those in the highest third of vitamin C dietary intake (equating to something like 3 times the RDA of 60mg) had a third less progression of lens opacities.
MedicalResearch.com Interview with: Dong Hyun Kim, M.D. Clinical assistant professor, Department of Ophthalmology, Gil Medical Center, Gachon University Incheon, Korea MedicalResearch.com: What is the background for this study? Dr. Kim: Air pollution is an important public health concern nowadays and ocular surface is continuously exposed to the outdoor air pollutants. Dry eye disease is a representative ocular surface...
Dr. Albert Siu[/caption]
Dr. Albert Siu M.D., M.S.P.H.
Chair of the U.S. Preventive Services Task Force
Chairman and professor of the Brookdale Department of Geriatrics and Palliative Medicine
Icahn School of Medicine at Mount Sinai
Director of the Geriatric Research, Education, and Clinical Center
James J. Peters Veterans Affairs Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Siu: Impaired vision is a serious and common problem facing older adults and can affect their independence, ability to function, and quality of life. When the Task Force reviewed the research around screening older adults for vision impairment in a primary care setting, we concluded that the current evidence is insufficient to assess the balance of benefits and harms. As a result, we issued an I statement, which is consistent with the 2009 final and 2015 draft recommendations.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Siu: Older adults who are having problems seeing should talk to their primary care doctor or an eye specialist. Primary care doctors can explore the various causes of vision problems and do an eye exam to check for refractive error. An eye specialist can do a full eye exam to look for and treat refractive errors and other eye conditions that affect vision, such as cataracts and age-related macular degeneration (AMD). With regards to clinicians, in the absence of clear evidence, they should use their clinical judgment when deciding whether to screen patients who have not reported any concerns about their vision.
Adam Glassman[/caption]
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
Medical Research: What is the background for this study? What are the main findings?
Response: Diabetic macular edema (DME) involves a build-up of blood and fluid in the macula, the part of the eye needed for sharp, straight-ahead vision. Diabetic macular edema can occur in people with diabetic retinopathy and is the most common cause of diabetes-related vision loss. Anti-VEGF agents are the first line treatment for most U.S. retinal specialists to treat vision loss from DME. There are three commonly used agents to treat DME, EYLEA, Avastin, and Lucentis. Eylea and Lucentis are FDA approved for Diabetic macular edema treatment. However, Avastin is used off-label in repacked aliquots containing approximately 1/500th of the systemic dose used in cancer therapy. The costs of these agents vary substantially, with Eylea priced at $1,850 per injection, Lucentis at $1,170, and repackaged Avastin at $60. Results of this study, conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) and funded by the NIH, found that all three agents are effective at improving vision and reducing DME over 2 years. When vision loss is relatively mild at baseline (20/32-20/40), all three agents are similarly effective at improving visual acuity. However, when vision loss at baseline is worse, Eylea outperforms Avastin at 2-years and also outperforms Lucentis at one year, but the difference between Eylea and Lucentis diminishes and is no longer statistically different at 2 years. The percentage of participants that experienced a systemic adverse events such as heart attack, stroke, or death from an unknown cause was greater with Lucentis (12%) versus Eylea (5%) and Avastin (8%). However, similar findings have not been seen in most previous studies.
Dr. J. William Harbour[/caption]
J. William Harbour, MD
Professor & Vice Chairman
Dr. Mark J. Daily Endowed Chair
Director, Ocular Oncology Service
Bascom Palmer Eye Institute
Interim Associated Director for Basic Research
Leader, Eye Cancer Site Disease Group
Sylvester Comprehensive Cancer Center
Member Interdisciplinary Stem Cell Institute
University of Miami Miller School of Medicine
Biomedical Research Building, Room 824
Miami FL 33136
Medical Research: What is the background for this study? What are the main findings?
Dr. Harbour: Gene expression profiling has become the predominant means of molecular prognostic testing in uveal melanoma, with primary tumors being divided into Class 1 (low metastatic risk, about two thirds of cases) and Class 2 (high metastatic risk, about one third of cases). In this study, we identified a new biomarker for uveal melanoma that subdivides Class 1 tumors based on the mRNA expression of the oncogene PRAME. Class 1 tumors not expressing PRAME have an extremely low metastatic risk, whereas those expressing PRAME have an intermediate metastatic risk.