Author Interviews, Infections, NIH, Ophthalmology / 05.12.2018

MedicalResearch.com Interview with: Top, retina of a control patient. Bottom, retina from a patient with CJD. Arrowheads point to abnormal prions in the outer plexiform layer (opl), and the asterisk (*) marks more diffuse prions in the inner plexiform layer (ipl).Orrù et al., mBioByron Caughey, Ph.D. Senior Investigator Chief, TSE/prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, MT 59840 USA  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Corneal transplants have caused the transmission of Creutzfeldt-Jakob disease (CJD) in at least two cases, and pathological prion protein has been detected in the retinas of the eyes of sporadic CJD cases. To build on these previous indications of prions in eye tissue, we tested the distribution of prions in various components of eyes from 11 sCJD decedents. We applied a highly sensitive surrogate test for prions (RT-QuIC) that indicated that all of the sCJD cases had prions in multiple parts of their eye, including the cornea and sclera, which is the white outer surface of the eye. Retinas were usually contained the highest levels, in some cases approaching levels in the brain. Some other parts such as the cornea, lens and vitreous had much lower, but detectable, levels.  (more…)
Author Interviews, JAMA, Ophthalmology, Pediatrics / 19.11.2018

MedicalResearch.com Interview with: "i have a lazy eye but it's a good thing" by jessica mullen is licensed under CC BY 2.0Eileen E. Birch, PhD Director, Crystal Charity Ball Pediatric Vision Evaluation Center Retina Foundation of the Southwest Adjunct Professor of Ophthalmology UT Southwestern Medical Center   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We previously reported that amblyopia, but not nonamblyopic strabismus or anisometropia, is associated with slower reading speed (Kelly et al  Journal of AAPOS 2015) and that this is related to abnormal eye movements and unstable fixation associated with amblyopia (Kelly et al 2017).  We have also shown that amblyopic children are slower at completing Scantron answer sheets (JAMA Ophthalmology 2018).  We thought that these difficulties experiences in school-age children with amblyopia might affect their self-perception. (more…)
Author Interviews, JAMA, Ophthalmology / 09.11.2018

MedicalResearch.com Interview with: Jennifer P. Craig, Associate Professor Department of Ophthalmology New Zealand National Eye Centre Auckland, New Zealand MedicalResearch.com: What is the background for this study? Response: Dry eye disease is a complex multi-factorial condition, which affects between 5% to 50% of the adult population in different parts of the world. The condition can have profound effects on the ocular comfort, visual function, and quality of life of sufferers. In both clinical practice and academic research settings, validated questionnaires are frequently used to screen for dry eye symptomology, before clinical assessment of tear film homeostatic markers is conducted to make an overall diagnosis of dry eye disease. Although a large number of validated symptomology questionnaires has previously been developed, the recently convened Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWS II) identified that the considerable heterogeneities in the study populations, methodologies, and reference standards used in earlier diagnostic accuracy studies introduced significant challenges when trying to compare the diagnostic performance of these screening instruments. The current study is the first to offer a direct comparison of five commonly used validated questionnaires within the same study population, and uses the global consensus criteria for tear film homeostatic disturbance developed by the TFOS DEWS II as the reference standard. (more…)
Author Interviews, Health Care Systems, Ophthalmology / 07.11.2018

MedicalResearch.com Interview with: Nathan Radcliffe, MD Senior Faculty, Ophthalmology Glaucoma and Cataract surgeon Mount Sinai Health System MedicalResearch.com: What is the background for this study? Response: Glaucoma is a leading cause of blindness and the mainstay of therapy is to lower the intraocular pressure (IOP) with topical eye drops. Up to 40% of patients may require more than one eye drop to control the disease, and yet taking more than one eye drop bottle can result in higher costs, more eye irritation, worse therapeutic compliance, and possibly worse outcomes, be sure to consult your eye surgeon before increasing any eye treatment to ensure it won't do any further damage to the eye. Compounded therapies (not FDA approved, but made at the physician’s request by a compounding pharmacy) can be created to contain multiple glaucoma therapies in one bottle. We sought to determine if a compounded solution containing three or four drops in one bottle could control glaucoma as well as three or four separate bottles (standard of care) in patients requiring three or four eye drop bottles to control glaucoma. We performed a multi-center, randomized, observer-masked, parallel-group study comparing a compounded therapy containing latanoprost 0.05%, dorzolamide hydrochloride 2%, timolol maleate 0.5%, brimonidine tartrate 0.2% with 0.01% BAK to standard three or four bottle regaimins. We measured IOP and corneal staining (a sign of preservative toxicity), as well as other safety measures at week one, month one, two and three. (more…)
Author Interviews, Columbia, Environmental Risks, Genetic Research, Ophthalmology, PLoS / 09.10.2018

MedicalResearch.com Interview with: Andrei V. Tkatchenko, M.D., Ph.D. Associate Professor Columbia University Medical Center Edward S. Harkness Eye Institute New York, NY 10032 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clear distance vision is rapidly becoming a rare privilege around the world, especially in Asia, due to increasing prevalence of myopia. Although much effort has been directed towards elucidating the mechanisms underlying refractive eye development and myopia, treatment options for myopia are mostly limited to optical correction, which does not prevent progression of myopia or pathological blinding complications often associated with the disease. During early childhood development, the axial length of the eye normally grows to match its optical power in a process called emmetropization, producing focused images on the retina. However, very often environmental and genetic factors lead to a mismatch between the optical power of the eye and its axial length resulting in the development of myopia if eyes grow too long for their optical power. Experimental studies in many animal species suggest that emmetropization is regulated by optical defocus. The eye can compensate for imposed negative and positive optical defocus by increasing or decreasing its growth rate, respectively. However, the molecular mechanisms underlying emmetropization are poorly understood which prevents development of anti-myopia drugs. (more…)
Accidents & Violence, Author Interviews, Geriatrics, JAMA, Ophthalmology, University of Pittsburgh / 05.10.2018

MedicalResearch.com Interview with: Syed Mahmood Ali Shah, M.D. Associate Professor of Ophthalmology University of Pittsburgh School of MedicineSyed Mahmood Ali Shah, M.D. Associate Professor of Ophthalmology University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Eye trauma is a significant cause of morbidity throughout the world. In the United States, the incidence of individuals hospitalized with eye trauma from 2001 through 2014 increased. Most of these individuals were above the age of 65 and suffered a fall. This is a worrisome trend in light of an increased awareness and continued and concentrated effort to reduce falls. This is a critical point: We need to improve our existing strategies to reduce falls. The second at-risk group is children and adolescents. Previous studies have shown that effective widespread implementation of injury prevention efforts can lower trauma rates. While we did observe a small decrease in eye trauma as a primary admitting diagnosis, the fact that it was more common in children and adolescents (for whom eye trauma carries devastating consequences and can significantly reduce quality of life) highlights the significance of continued efforts to prevent eye trauma.  (more…)
Author Interviews, Cleveland Clinic, Diabetes, JAMA, Ophthalmology / 05.10.2018

MedicalResearch.com Interview with: Amy Babiuch, M.D. Medical Retina Specialist  |  Cole Eye Institute Assistant Professor Ophthalmology Case Western Reserve University WPSA Regional Focus Committee Chair Cleveland Clinic MedicalResearch.com: What is the background for this study? Response: In previous studies, the disorganization of retinal inner layers (DRIL) has demonstrated its ability to help determine visual acuity (VA) prognosis in diabetic macular edema that requires treatment. Given this association, the research group at Cole Eye Institute studied how DRIL may affect VA outcomes in patients with retinal vein occlusion (RVO) undergoing treatment for secondary macular edema. DRIL is defined as the extent to which there is a failure in the recognition of any of the demarcations between the ganglion cell-inner plexiform layer complex, inner nuclear layer, and outer plexiform layer on optical coherence tomography (OCT). (more…)
Author Interviews, JAMA, Ophthalmology, Toxin Research / 14.09.2018

MedicalResearch.com Interview with: “Vision” by Victoria Ford is licensed under CC BY 2.0Adam J. Paulsen MS Associate Researcher EpiSense Research Program Department of Ophthalmology&  Visual Sciences University of Wisconsin - Madison MedicalResearch.com: What is the background for this study? Response: Contrast Sensitivity is a measure of visual function that indicates how well a person is able to distinguish an object against its background.  Tests of CS determine how faint a visual signal can be identified.  CS can be diminished even in those with appropriately corrected visual acuity, has been shown to have effects on daily activities (including near vision tasks), risk of falls, and driving ability.  The causes of and risks for CS impairment are understudied.  Cadmium (Cd) and Lead (Pb) are known neurotoxins that have been shown to accumulate in the retina.  Both Cd and Pb have common sources of exposure in the general population.  Our studied aimed to investigate risk factors for incident CS impairment, including Cd and Pb exposure. (more…)
Author Interviews, JAMA, Ophthalmology, Primary Care, University of Michigan / 11.09.2018

MedicalResearch.com Interview with: Joshua Ehrlich, MD, MPH Assistant Professor of Ophthalmology and Visual Sciences University of Michigan  MedicalResearch.com: --Describe the “important role” that primary care providers play in promoting eye health? Response: Primary care is the entryway into the health system for many individuals. The poll suggests that when primary care providers discuss vision with their patients, they are more likely to get eye exams. It also suggests that primary care providers are having these conversations most often with those who have certain risk factors for eye disease, such as diabetes or a family history of vision problems, as well as those with fewer economic resources. Promoting these kinds of conversations could bolster this trend, increasing the number of diabetics and other high risk individuals who get appropriate eye care. (more…)
Author Interviews, Compliance, JAMA, Macular Degeneration, Ophthalmology / 25.08.2018

MedicalResearch.com Interview with: Jason Hsu, MD Retina Service, Wills Eye Hospital Associate Professor of Ophthalmology Thomas Jefferson University Mid Atlantic Retina Anthony Obeid MD MPH School of Public Health The University of Sydney · MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Neovascular age-related macular degeneration (nAMD) is a vision-threatening disease that often afflicts elderly patients. The introduction of intravitreal anti-vascular endothelial growth factor treatment drastically improved the prognosis of eyes with nAMD. Despite its efficacy, patients require consistent follow-up (sometimes as often as monthly), with ongoing injections to maintain the visual benefits of the drug. Unfortunately, few studies have reported the number of patients that do not follow-up with recommended guidelines. Moreover, there remains limited evidence on the risk factors associated with loss to follow-up. Our study, consisting of 9007 patients with a history of nAMD receiving treatment between 2012 and 2016, evaluated both these parameters. We defined loss to follow-up as having at least one injection without a subsequent follow-up visit within 12 months post-treatment. Using this definition, we found that over 20% of patients are lost to follow-up over the entire study period. We further identified key risk factors associated with loss to follow-up, which included patients of older age, race, patients residing in a region of a lower average adjusted gross income, patients living at greater distances from clinic, patients with active nAMD in only one eye, and patients with worse visual acuity. (more…)
Author Interviews, Education, JAMA, Ophthalmology, Pediatrics / 20.07.2018

MedicalResearch.com Interview with: Aparna Raghuram, OD, PhD Optometrist, Department of Ophthalmology Instructor, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Developmental dyslexia is a specific learning disability of neurobiological origin whose core cognitive deficit is widely believed to involve language (phonological) processing. Although reading is also a visual task, the potential role of vision has been controversial, and experts have historically dismissed claims that visual processing might contribute meaningfully to the deficits seen in developmental dyslexia. Nevertheless, behavioral optometrists have for decades offered vision therapy on the premise that correcting peripheral visual deficits will facilitate reading. Yet there is a surprising dearth of controlled studies documenting that such deficits are more common in children with developmental dyslexia, much less whether treating them could improve reading. In the present study, we simply assessed the prevalence and nature of visual deficits in 29 school aged children with developmental dyslexia compared to 33 typically developing readers. We found that deficits in accommodation 6 times more frequent in the children with developmental dyslexia and deficits in ocular motor tracking were 4 times more frequent. In all, more than three-quarters of the children with developmental dyslexia had a deficit in one or more domain of visual function domain compared to only one third of the typically reading group. (more…)
Aging, Alzheimer's - Dementia, Author Interviews, JAMA, Ophthalmology / 29.06.2018

MedicalResearch.com Interview with: “Old Eyeglasses” by Leyram Odacrem is licensed under CC BY 2.0Diane Zheng MS NEI F-31 Research Fellow and a Ph.D. candidate in Epidemiology Department of Public Health Sciences University of Miami MedicalResearch.com: What is the background for this study? Response: Worsening vision and declining cognitive function are common conditions among older people. Understanding the association between them could be beneficial to alleviate age related cognitive decline. (more…)
Author Interviews, Ophthalmology, Pediatrics / 14.06.2018

MedicalResearch.com Interview with: multiple choice test takingKrista Kelly, PhD Postdoctoral Fellow Crystal Charity Ball Pediatric Vision Evaluation Center Retina Foundation of the Southwest Dallas, TX 75231 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We were interested in seeing whether the fine motor deficits typically seen in amblyopia (lazy eye) and strabismus (crossed eyes) translate to an academic setting. Namely, transferring answers to a multiple choice answer form widely used in standardized testing in schools. Children with amblyopia and strabismus took about 28% longer than their peers transferring answers to a multiple choice answer form, even though they have good vision in one or both eyes.  (more…)
Author Interviews, Ophthalmology / 09.06.2018

MedicalResearch.com Interview with: “pplkpr phone” by Kyle McDonald is licensed under CC BY 2.0Michelle Nguyen Senior Director, Consumer Marketing Lead Shire Ophthalmics MedicalResearch.com: What is the background for this initiative? How does screen time affect eye health?  Response: Screen responsibly is an educational initiative about the intersection between our screen use and eye health. This initiative is underscored by new national survey data and aimed at increasing our dialogue about how to love both our screens and our eyes. Screen responsibly is an extension of the eyelove campaign, which Shire launched in 2016 to elevate the importance of eye health and raise awareness of the signs and symptoms of Chronic Dry Eye, commonly referred to as Dry Eye. Since being glued to your screen can trigger Dry Eye symptoms, it is important that people are aware of ways to screen responsibly.  MedicalResearch.com:  How common is the problem of Dry Eye? How is it related to excessive screen time? Response: In the United States, nearly 30 million adults report symptoms consistent with Dry Eye. Dry Eye symptoms include a burning, itchy, stinging or gritty feeling in the eyes, episodes of blurred vision, eye redness and watery eyes. Shire is committed to addressing unmet needs within the Dry Eye patient community, and to do so, we sought to better understand their current behaviors, perceptions and knowledge around a common trigger of Dry Eye symptoms – intense screen usage. (more…)
Author Interviews, Genetic Research, Ophthalmology / 05.04.2018

MedicalResearch.com Interview with: Wen-Tao Deng, Ph.D. Department of Ophthalmology, College of Medicine| University of Florida, Gainesville, FL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Blue cone monochromay (BCM) is a devastating vision disorder characterized by loss function of both L- and M-cones due to mutations in the L- and M-opin gene cluster on the X chromosome. BCM patients display severely reduced visual acuity, loss of color-vision, myopia, nystagmus, and minimally detectable cone-mediated electroretinogram. In our studies, we showed that an M-opsin knockout mouse model resembles human BCM, and expression of either human M- or L-opsin individually or combined through adeno-associated viral vector promotes regrowth of cone outer segments and rescues M-cone function in the treated M-opsin dorsal retin (more…)
Author Interviews, Ophthalmology, Stem Cells, Stroke / 28.03.2018

MedicalResearch.com Interview with: Steven Levy MD CEO, MD Stem Cells Study Director, Stem Cell Treatment Studies MedicalResearch.com: What is the background for this study? Response: MD Stem Cells is the sponsor of the Stem Cell Ophthalmology Treatment Study II (SCOTS 2) the largest stem cell study currently addressing retinal and optic nerve disease (NCT 03011541). SCOTS uses autologous bone marrow derived stem cells (BMSC) typically provided to the eyes by combining retrobulbar, subtenons and intravenous injections. Many retinal and optic nerve diseases are eligible including Retinitis Pigmentosa (RP), Age Related Macular Degeneration (AMD), Stargardts, Ushers, Glaucoma, Ischemic Optic Neuropathy, Optic Atrophy and others. Statistically significant improvements have been documented in key diseases and positive responses have been noted across most conditions treated. Mechanisms of action may include differentiation of the CD34 cells into neurons, secretion of neurotrophic factors, transfer of mitochondria and release of mRNA. These may benefit existing stressed cells as well as provide replacement of damaged or absent cells. (more…)
Author Interviews, Ophthalmology, Technology / 28.03.2018

MedicalResearch.com Interview with: Dr. Caroline A. Blackie, OD PhD FAAO Medical Director, Dry Eye Johnson & Johnson Vision MedicalResearch.com: What is the background for these studies? Would you briefly explain the problem of dry eye, how common it is and why it is difficult to treat?  Response: Dry eye disease is a condition where the eyelids and/or the tear film are unable to protect the ocular surface from the negative effects of desiccating stress. If left untreated, a vicious cycle ensues resulting in a broad spectrum of sequelae, including ocular discomfort and compromised vision. The result is partial or pervasive reduced quality of life for the individual along with a significant economic burden on our society. Conversely, when the ocular surface is healthy, patients feel better, see better and live better. Meibomian gland health is essential for ocular surface health. Meibomian glands secrete the oils necessary to protect the ocular surface from the negative effects of desiccating stress. Predictably, meibomian gland dysfunction (MGD) is a leading cause of dry eye disease. MGD is almost always the result of thickened and stagnated gland secretions. These stagnated secretions obstruct and/or limit the flow of functional oil into the tear film. MGD is the most common form of dry eye disease and is also known as evaporative dry eye. While management of dry eye in general can be complex, the management of MGD affords a relatively straightforward approach, which is to improve meibomian gland function by treating obstruction. Dry eye disease is pretty common – more than 340 million people suffer from it globally. Short-term management of dry eye involves improving signs and symptoms of the condition, including the use of tear supplementation and reducing ocular surface inflammation. Long-term dry eye management requires that the cause (or causes) of the condition is also diagnosed and treated. That cause is often MGD, and MGD can be successfully managed with LipiFlow®.  (more…)
Author Interviews, JAMA, Ophthalmology, University of Michigan / 16.03.2018

MedicalResearch.com Interview with: Maria A. Woodward, MD, MSc Department of Ophthalmology and Visual Sciences W. K. Kellogg Eye Center Institute for Healthcare Policy and Innovation University of Michigan Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Many people go to emergency departments seeking care for their eye problems. We wished to investigate which factors are associated with the involvement of ophthalmologist consultants in the care of these patients and whether any disparities exist.  (more…)
Author Interviews, Multiple Sclerosis, Ophthalmology, Pharmaceutical Companies / 08.03.2018

MedicalResearch.com Interview with: Sarah A. Morrow MD, MS, FRCPC Associate Professor of Neurology Department of Clinical Neurological Sciences University of Western Ontario (Western) MedicalResearch.com: What is the background for this study? Response: Acute demyelinating optic neuritis, which presents with loss of vision and painful eye movements, is common in multiple sclerosis (MS) occurring 50% of persons with MS. High dose (≥ 1g) corticosteroids administered through an IV became the standard of practice after the landmark Optic Neuritis Treatment Trial as IV administration. However, in that study the IV dose of corticosteroids was much higher (1 gram daily) than the oral dose (1 mg/kg). Thus, it is not clear if IV administration is still better if equivalent doses are used orally. Oral administration is much more convenient for patients and less expensive, and previous studies showed that it is preferred by patients. In this study, we asked the following question: are high dose (≥ 1000mg) IV corticosteroids superior to equivalent doses of oral corticosteroids for the acute treatment of optic neuritis? We randomly assigned fifty-five cases of acute optic neuritis to 1000mg IV methylprednisolone or 1250mg oral prednisone daily for three days and compared recovery of their vision over the next 6 months.  (more…)
Author Interviews, Emory, Genetic Research, JAMA, Ophthalmology / 24.01.2018

MedicalResearch.com Interview with: Eldon E. Geisert, PhD Professor of Ophthalmology Emory School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the late 1990s a group of doctors began a study of glaucoma patients to determine if there were phenotypes that are predictive for developing glaucoma. In this Ocular Hypertension Treatment Study (OHTS) one of the highly correlated ocular traits was central corneal thickness (CCT). The early clinical studies found that people with thinner corneas were at a higher risk of developing glaucoma. In two large studies, examining thousands of people a number of genes were identified that were risk factors for glaucoma or that controlled CCT in humans. In both cases the identified genes accounted for less than 10% of the genetic risk for glaucoma and less than for 10% of the genetic control for CCT. There was little data linking the genetic control of CCT to the glaucoma risk. Our group has taken an indirect approach to the question, using well-defined mouse genetic system to identify genes modulating CCT and then interrogating human glaucoma data to determine if these genes are associated with glaucoma risk.   (more…)
Author Interviews, Cost of Health Care, JAMA, Ophthalmology, Surgical Research, UCSF / 23.01.2018

MedicalResearch.com Interview with: Catherine L. Chen, MD, MPH Assistant Professor UCSF Department of Anesthesia & Perioperative Care MedicalResearch.com: What is the background for this study? What are the main findings? Response: Routine preoperative medical testing (such as common laboratory tests looking at a patient's blood cell counts and kidney function, or cardiac tests like an EKG) are not recommended in patients undergoing cataract surgery, but these tests still occur quite frequently among Medicare cataract surgery patients because these patients tend to be older and sicker than the general population. In the past, researchers have used a 30-day window counting backwards from the date of surgery to determine whether a given test should be categorized as a routine preoperative test. However, we know that testing often takes place outside this window and therefore, the frequency and cost of routine preoperative medical testing has generally been underreported. In our study, we used a new method to figure out how to determine the start of the routine preoperative testing period. In cataract patients, ocular biometry is a diagnostic test that is performed in anticipation of cataract surgery, and this test is only performed in cataract patients who will be having cataract surgery in the near future. For each patient, we calculated the elapsed time between the ocular biometry and cataract surgery dates to get a better idea of when to start looking for unnecessary routine preoperative testing. Our goal was to identify all the routine preoperative medical testing that occurs once the decision has been made to operate and better estimate the cost to Medicare of this unnecessary testing. In a previous study that we published in the New England Journal of Medicine, we reported a significant spike in the rate of routine preoperative medical testing that occurs in the 30 days before surgery compared to the baseline rate of testing. In our current study, we discovered that there is a second spike in testing that occurs in the 30 days after ocular biometry. In fact, even if you exclude the testing that takes place during the 30 days before surgery, there is still a 41% increase in testing rates during the interval between ocular biometry and cataract surgery over the baseline rate of testing. In addition, we found that the cost of routine preoperative testing was 47% higher when looking at the entire biometry to surgery timeframe compared to testing that occurs just in the 30 days before surgery. We estimate that the cost to Medicare of all of this unnecessary testing approaches $45.4 million annually. (more…)
Author Interviews, Ophthalmology, Technology / 22.01.2018

MedicalResearch.com Interview with: Ireneusz Grulkowski, PhD Assistant Professor Bio-Optics & Optical Engineering Lab Institute of Physics Nicolaus Copernicus University MedicalResearch.com: What is the background for this study? Response: The ophthalmic diagnostics has undergone a revolution over the last 30 years. The access to new modalities allowed to understand the process of development of different eye diseases of the retina and the anterior segment. In particular, optical coherence tomography (OCT) demonstrated the feasibility in visualization of microarchitecture of the ocular tissues. However, most of the ophthalmic equipment is dedicated either to imaging the anterior segment of the eye (e.g. the cornea) or to retinal imaging. This is due to the fact that the eye is composed of the elements, such as the cornea and the lens, that refract the light. In this report, we wanted to address that challenge. We compensated the refractive power of the eye by the application of the tunable lens. The focus tunable lens is the example of active optical element that changes its focal distance with the applied electric current. (more…)
Author Interviews, FDA, Genetic Research, Ophthalmology / 15.01.2018

MedicalResearch.com Interview with: Dr. Stephen Rose PhD Chief Research Officer Foundation Fighting Blindness (FFB) Dr. Rose comments on the announcement of the FDA approval of voretigene neparvovec (LUXTURNA™) gene therapy for inherited blindness due to mutations in the RPE65 gene. What is the background for this announcement? What were the main findings from the study? Response: While it has been 30 years since the RPE65 gene was identified as causing Leber’s Congenital Amaurosis, this shows that it is possible to have an effective gene therapy for an inherited disease. As the first gene therapy for the eye or for an inherited disease, LUXTURNA is a historic milestone in the search for cures for all inherited retinal diseases (IRDs). As a one-time gene therapy, LUXTURNA will not only be life-changing for patients with vision loss due to mutations in the RPE65 gene, it also provides critical momentum for gene therapies - for the eye and other diseases - now in the clinic.  (more…)
Author Interviews, JAMA, Ophthalmology, Pediatrics / 14.01.2018

MedicalResearch.com Interview with: Prof. Dr. Andreas Stahl Geschäftsführender Oberarzt Leiter Arbeitsgruppe Angiogenese Universitätsaugenklinik Freiburg | University Eye Hospital Freiburg Freiburg, Germany MedicalResearch.com: What is the background for this study? Response: Retinopathy of prematurity (ROP) is a sight-threatening disease and one of the main reasons for irrreversible bilateral blindness in children. Particularly infants born at very early gestational ages or with very low birth weight are affected. In these infants, vascularization of the retina is unfinished at the time of birth. Severeal weeks into the life of these very prematuerly born infants, angiogenic growth factors, mainly vascular endothelial growth factor (VEGF), become upregulated in the avascular parts of the retina, leading to a re-activation of physiologic vascular growth. If all goes well, these re-activated retinal blood vessels progress towards the periphery and lead to a fully vascularized and functional retina. If, however, the vascular activation by VEGF is too strong, then vascular growth becomes disorganized and vessels are redirected away from the retina and into the vitreous. If left untreated, these eyes can then proceed towards tractional retinal detachment and blindness. Since the 1990s, the standard method of treating ROP has been laser photocoagulation of avascular parts of the retina. This treatment is sensible because VEGF as the main angiogenic driver of pathologic blood vessel growth is expressed in these avascular parts of the retina. The downside of laser treatment, however, is that treated retinal areas are turned into functionless scar tissue and are lost for visual function. In addition, infants treated with laser need to be under general anesthesia for hours during treatment which can be troublesome in very young and fragile preterm infants. And in the long run, infants treated with laser have a high risk of developing high myopia in later life. (more…)
Allergan, Author Interviews, JAMA, Ophthalmology / 05.01.2018

MedicalResearch.com Interview with: Steven Woloshin, MD MS Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine The Center for Medicine in the Media Dartmouth Institute for Health Policy and Clinical Practice Lebanon, New Hampshire MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a lot of debate about the legal maneuvers (ie, transferring patents to the Mohawk Indians) Allergan has employed to delay marketing of generic alternatives to Restasis (cyclosporine ophthalmic emulsion 0.05%).   But there is a more fundamental question that has received little attention:  Does Restasis work?  It is not approved in the European Union, Australia or New Zealand where registration applications were "withdrawn prior to approval due to insufficient evidence of efficacy" in 2001.   Although Canada approved Restasis, its national health technology assessment unit, unconvinced of meaningful benefit, recommended Canada not pay for it - according to our research, no Canadian provincial or federal drug plan currently does.   Nevertheless, Americans have spent $8.8 billion in total sales between 2009 and 2015 on Restasis, including over $2.9 billion in public monies through Medicare Part D. (more…)
Author Interviews, Infections, Ophthalmology, Surgical Research / 14.12.2017

MedicalResearch.com Interview with: Penny Asbell, MD Icahn School of Medicine Mt. Sinai, New York City. MedicalResearch.com: What is the background for this study? ─     Bacterial endophthalmitis is a serious, although infrequent, complication of ocular surgery, typically caused by perioperative introduction of bacterial flora from the patient’s own conjunctiva and skin. ─     Prophylactic measures such as perioperative antibiotic treatment may minimize the risk for endophthalmitis, but can be complicated by antibiotic resistant bacteria. ─     The ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) study is the only nationwide antibiotic resistance surveillance program specific to ocular pathogens. ─     The purpose of this presentation is to report on the antibiotic susceptibility profiles of bacterial isolates from the vitreous and aqueous humor collected in the ARMOR study expanding upon earlier findings. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, Technology / 13.12.2017

MedicalResearch.com Interview with: Dr. Tien Yin Wong MD PhD Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Medical School, National University of Singapore Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Currently, annual screening for diabetic retinopathy (DR) is a universally accepted practice and recommended by American Diabetes Association and the International Council of Ophthalmology (ICO) to prevent vision loss. However, implementation of diabetic retinopathy screening programs across the world require human assessors (ophthalmologists, optometrists or professional technicians trained to read retinal photographs). Such screening programs are thus challenged by issues related to a need for significant human resources and long-term financial sustainability. To address these challenges, we developed an AI-based software using a deep learning, a new machine learning technology. This deep learning system (DLS) utilizes representation-learning methods to process large data and extract meaningful patterns. In our study, we developed and validated this using about 500,000 retinal images in a “real world screening program” and 10 external datasets from global populations. The results suggest excellent accuracy of the deep learning system with sensitivity of 90.5% and specificity of 91.6%, for detecting referable levels of DR and 100% sensitivity and 91.1% specificity for vision-threatening levels of DR (which require urgent referral and should not be missed). In addition, the performance of the deep learning system was also high for detecting referable glaucoma suspects and referable age-related macular degeneration (which also require referral if detected). The deep learning system was tested in 10 external datasets comprising different ethnic groups: Caucasian whites, African-Americans, Hispanics, Chinese, Indians and Malaysians (more…)
Author Interviews, Environmental Risks, NYU, Ophthalmology / 08.12.2017

MedicalResearch.com Interview with: Cassandra Thiel, PhD Assistant Professor in the Departments of Population Health and Opthamology at NYU Langone Health, and Assistant Professor at NYU Wagner and NYU Tandon School of Engineering MedicalResearch.com: What is the background for this study? Response: Everyone is concerned about the health impacts of climate change, from the United Nations to the Lancet. While other industries are trying to monitor and minimize their environmental footprint, healthcare services have been largely overlooked. Yet, the US healthcare sector emits 10% of the US’s total greenhouse gases. Cataract surgery is one of the most commonly performed procedures in the world. In the US, these surgeries generate large quantities of waste due to the use of single-use, disposable materials and supplies. However, at Aravind Eye Care System in southern India, the outcomes for this procedure are the same as in the US, but the materials they use are mostly reusable. This study assessed the environmental footprint of Aravind’s surgical process, to determine how their process design and material selection affected their emissions. (more…)