miLOOP Uses Minimal Energy To Encapsulate and Remove Cataracts

MedicalResearch.com Interview with:

Sean Ianchulev, MD MPH Chief Medical Officer VP of Medical Affairs and Business Development Transcend Medical 

Dr. Ianchulev

Sean Ianchulev, MD MPH
Chief Medical Officer
VP of Medical Affairs and Business Development
Transcend Medical 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Similar to MIGS stent technology for glaucoma, MiLOOP is a an application of micro-interventional technology for cataract surgery – allows the fragmentation of the lens with simple micro-interventional pen-like device which does not require complex, capital-intense phaco-emulsification…also it does not require vibrational energy

MedicalResearch.com: What should readers take away from your report?

 Iantech introduces a micro-­interventional devices designed to deliver energy-­free endocapsular lens fragmentationResponse: That after 50 years of conventional phacoemulsification cataract technology, new breakthrough micro-interventional approaches are on the horizon.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Future studies will evaluate whether micro-interventional approaches for cataract surgery can replace phacoemulsification equipment altogether.

Any disclosures?

I am the founder and Chairman of the company.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation: Ianchulev S. Microinterventional cataract surgery. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans. 

 

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

 

 

FDA Advisory Committee Recommended Approval of First Gene Therapy For Inherited Eye Disease

MedicalResearch.com Interview with:
Dr. Stephen M. Rose, PhD Chief Research Officer Foundation Fighting BlindnessDr. Stephen M. Rose, PhD
Chief Research Officer
Foundation Fighting Blindness

Dr. Rose discusses the FDA advisory panel unanimously recommended approval of Spark Therapeutics’ Gene Therapy Luxturna  for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal dystrophies, a group of rare blinding conditions caused by one of more than 220 different genes.

MedicalResearch.com: Would you tell us a little about IRD? Whom does it affect and how?  How common is this disorder?

Response: The retina at the back of the eye is responsible for collecting light and turning it into signals that are transmitted to the brain and interpreted as vision. Think of the retina as the film in a camera, or more recently the sensor at the back of a digital camera. Inherited rare retinal degenerations are when the retina at the back of the eye deteriorates and loses its ability to capture light, thereby leading to blindness.

iRDs can affect anyone, no matter race or ethnicity. These are inherited conditions that are passed down from parents to children, if a parent or both parents are either affected already or are carriers for a variant in any of the over 250 genes responsible for retinal degeneration.

There are over 15 different types of iRDs, with retinitis pigmentosa being the most common with a US affected population around 100,000. The rest of the iRDs make up another approximately 100,000 affected individuals in the US, so there are about 200,000 total affected individuals in the US. Worldwide these iRDs affect somewhere around one to two million individuals.

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Cataract Surgery Linked To Improved Health and Survival, As Well As Sight

MedicalResearch.com Interview with:

Anne L. Coleman, MD, PhD Center for Community Outreach and Policy, Stein Eye Institute David Geffen School of Medicine Director, UCLA Mobile Eye Clinic Department of Epidemiology, Fielding School of Public Health UCLA

Dr. Coleman

Anne L. Coleman, MD, PhD
Center for Community Outreach and Policy, Stein Eye Institute
David Geffen School of Medicine
Director, UCLA Mobile Eye Clinic
Department of Epidemiology, Fielding School of Public Health
UCLA

MedicalResearch.com: What is the background for this study?

Response: Cataracts are a leading cause of vision loss worldwide, and cataract surgery is an intervention that is known to be extremely effective to address the vision loss related to cataract. However, it is unclear if there are benefits of cataract surgery beyond vision improvement in people with cataracts. Previous studies have suggested that in addition to improving vision, cataract surgery may decrease the risk of fractures and accidents, improve mental health, and improve overall quality of life. The purpose of the present study was to further investigate the potential benefits of cataract surgery and to determine if cataract surgery was associated with increased survival in people with cataracts.

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Nerf Guns Can Cause Serious Eye Bleeding

Helgi Halldórsson from Reykjavík, Iceland Wikipedia image

A man aiming an N-Strike Stampede ECS
Wikipedia image

MedicalResearch.com Interview with:
Dr. Mukhtar Bizrah
Accident & Emergency Department,
Moorfields Eye Hospita
NHS Foundation Trust
London, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We noticed a number of patients presenting to the accident and emergency department at our hospital following ‘Nerf gun’ injuries. We decided to perform this study because an online literature search revealed that currently there was no published work on this topic. It was worth doing because it is a public health issue. A number of doctors in A&E commented that they have seen a number of patients present with Nerf gun injuries. I personally saw a patient which an inflamed eye and damage to the iris following a ‘Nerf gun’ injury.

We decided to write about three patients with bleeding in the eye (hyphema) because most journals have a cap on the number of patients in a case series. Also, bleeding in the eye following trauma is known to be associated with serious ocular injury and long term repercussions.

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Patients With Glaucoma Can Be Taught To Measure Their Own Intraocular Pressure

MedicalResearch.com Interview with:

Andrew Tatham Consultant Ophthalmologist Princess Alexandra Eye Pavilion and Department of Ophthalmology University of Edinburgh, Scotland

Dr. Tatham

Andrew Tatham, FRCOphth
Consultant Ophthalmologist
Princess Alexandra Eye Pavilion and Department of Ophthalmology
University of Edinburgh, Scotland 

MedicalResearch.com: What is the background for this study?

Response: Raised intraocular pressure (IOP) is the major risk factor for the development of glaucoma, the most common cause of irreversible blindness, with lowering IOP the only proven treatment.

Until recently the only way to measure IOP was for patients to visit their clinician  meaning it was only possible to obtain a limited number of measurements. This is problematic given that IOP fluctuates and that 75% of individuals have peak IOP outside office hours. If patients could measure their own IOP it would allow far more measurements to be obtained and result in better understanding of the variation and peaks in IOP. This could improve the detection of glaucoma and determine if patients are adequately controlled with medication.

Recently, a patient-operated, home IOP monitoring device (iCare HOME) has become available. The patient holds the device close to their eye and the device automatically determines if it is in the correct position to take a measurement. The tonometer then deploys a small probe which gently bounces off the surface of the eye to determine IOP. As the probe is only in contact with the surface of the eye for a few milliseconds no anesthetic is needed.

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Risky Behaviors Linked To Contact Lens–Related Eye Infections Among Adults and Adolescents

MedicalResearch.com Interview with:

Dr. Jennifer R. Cope MD Medical Officer Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases CDC

Dr. Cope

Dr. Jennifer R. Cope MD
Medical Officer
Division of Foodborne, Waterborne, and Environmental Diseases
National Center for Emerging and Zoonotic Infectious Diseases
CDC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Wearing contact lenses can increase your chances of getting a severe eye infection. Eye infections can lead to serious problems, including blindness. All contact lens wearers can help prevent serious eye infections by correctly wearing and caring for their contact lenses.

Eighty-one percent of young adults, 85% of adolescents, and 88% of older adults regularly did at least one risky behavior related to their contact lenses. The most frequently reported risk behaviors in adolescents were not visiting an eye doctor as least annually, sleeping or napping in lenses, and swimming in lenses.

Among young adults and older adults, the most frequently reported risk behaviors were replacing lenses at intervals longer than those prescribed, replacing lens storage cases at intervals longer than those recommended, swimming in lenses, and sleeping or napping in lenses.

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Does Maternal Preeclampsia Increase Risk of Retinopathy in Premature Infants?

MedicalResearch.com Interview with:

Mary Elizabeth Hartnett, MD, FACS, FARVO Professor of Ophthalmology, Vitreoretinal Service and Surgery Principal Investigator Retinal Angiogenesis Laboratory Director of Pediatric Retina, Adjunct Professor of Pediatrics John A. Moran Eye Center Salt Lake City UT 84132

Dr. Hartnett

Mary Elizabeth Hartnett, MD, FACS, FARVO
Professor of Ophthalmology, Vitreoretinal Service and Surgery
Principal Investigator Retinal Angiogenesis Laboratory
Director of Pediatric Retina, Adjunct Professor of Pediatrics
John A. Moran Eye Center
Salt Lake City UT 84132

On behalf of the co-authors: Julia Shulman, Cindy Weng, Jacob Wilkes, Tom Greene, M. Elizabeth Hartnett

MedicalResearch.com: What is the background for this study?

Response: Maternal preeclampsia causes morbidity to mothers and infants worldwide. Retinopathy of prematurity (ROP) is a leading cause of childhood blindness worldwide. This study was done to gain insight into the effects of preeclampsia on ROP in a clinical population.

The literature is mixed with some reports that preeclampsia increases risk of Retinopathy of prematurity, whereas others suggest preeclampsia is protective or has no effect. The presence of circulating anti-angiogenic factors in preeclamptic mothers that can enter the fetal circulation lends biologic plausibility to the notion that maternal preeclampsia might interfere with developing vascular beds in the fetus, such as the retina, and potentially lead to severe ROP. However, a report using an experimental model provided evidence that uteroplacental insufficiency, a characteristic of preeclampsia, led to protective mechanisms in the offspring that reduced oxygen-induced retinopathy and promoted overall growth.

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Diabetic Retinopathy May Impact Daily Work and Activities

MedicalResearch.com Interview with:

Jeffrey R. Willis MD, PhD 

Dr. Willis

Jeffrey R. Willis MD, PhD
UC Davis Eye Center
University of California, Davis
Sacramento California

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Diabetic retinopathy is one of the leading causes of blindness in the United States.  Yet there is limited national level data on the impact of worsening DR on quality of life and visual function.

Our study aimed to address this knowledge gap by evaluating the functional burden of DR across severity levels, utilizing data from the National Health and Nutrition Examination Survey (NHANES).

We found that one-half of US adults with severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) had difficulty with ≥ 1 visual function task, possibly impacting their daily work/activities.  These patients reported a significantly greater vision-related functional burden relative to those with less severe forms of DR.

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Iris Freckles Are A Potential Biomarker for Chronic Sun Damage

MedicalResearch.com Interview with:

Iris Freckles Credit: © Africa Studio / Fotolia

Iris Freckles
Credit: © Africa Studio / Fotolia

Dr.med.univ. Christoph Schwab
Departement of Ophthalmology
Medical University of Graz
Graz, Austria 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Knowledge about risk factors and/or pathways involved in pathogenesis is from special importance in order of preventing diseases.

The role of sunlight in several eye diseases is unclear. In our study we found a close relation between sun light exposure – evaluated by a full body skin examination and a personal questionnaire – and iris freckles. Therefore we suggest the presence of iris freckles as a novel biomarker indicating high ocular sun exposure.

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One Time Injection With Spark’s Gene Therapy LUXTURNA Demonstrated Lasting Visual Improvement

MedicalResearch.com Interview with:

Stephen R. Russell, MD Dina J Schrage Professor of Macular Degeneration Research Service Director, Vitreoretinal Diseases and Surgery Professor of Ophthalmology and Visual Sciences The University of Iowa

Dr. Russell

Stephen R. Russell, MD
Dina J Schrage Professor of Macular Degeneration Research
Service Director, Vitreoretinal Diseases and Surgery
Professor of Ophthalmology and Visual Sciences
The University of Iowa

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study examines the efficacy (and safety) of treating children and adults with a form of retinitis pigmentosa known as RPE65-associated Lebers congenital amaurosis, with an adeno-associated viral vector(AAV) delivered RPE65 construct.  Building on successful phase 1/2b trials from multiple centers, the AAV-hRPE65v2 agent now designated as voretigene neparvovec, contains a highly optimized enhancing sequence and promoter.

The main findings were an improvement on a multiple light level mobility test (MLMT) and multiple additional supportive secondary endpoints which included improvements in full-field light sensitivity, Goldmann visual field, and others.

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Eyedrop Kallikrein Inhibitor Shows Promise for Diabetic Macular Edema

MedicalResearch.com Interview with:
Dr. David Kita, PhD Founder and Head of R&D Verseon CorporationDr. David Kita, PhD
Founder and Head of R&D
Verseon Corporation

MedicalResearch.com: What is the background for this study?

Dr. Kita: The preclinical data presented at the 2017 BIO International Conference provided details about Verseon’s plasma kallikrein inhibitors for the treatment of diabetic macular edema (DME).

DME affects millions of people worldwide and is a major cause of vision loss in patients with diabetes mellitus. Upregulation of the kallikrein-kinin system in response to diabetes can result in retinal vascular permeability, which can damage the retina and eventually lead to the central vision loss associated with DME.

The current treatment options for DME include intravitreal injections of anti-VEGF agents or corticosteroids into the eye and surgical laser treatments. Long-term use of intravitreal injections is associated with side effects such as inflammation, infections, and cataracts. For anti-VEGF drugs in particular, there is also a growing concern about geographic atrophy. In addition, about 50% of patients reported at most moderate vision improvements following anti-VEGF therapy in clinical trials. This highlights the need for a new treatment that can serve as a monotherapy or as an adjuvant to current therapies.

At Verseon, we are working on inhibitors of the serine protease plasma kallikrein (KLKB1) that can be administered either topically or orally. Verseon’s unique computer-driven drug discovery platform allows us to design potent, selective drug candidates that are unlikely to be found using traditional approaches. We have generated a number of chemically distinct series of KLKB1 inhibitors and optimized multiple lead candidates, which show good activity, permeability, and solubility.

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New Gene Mutation Found to Cause Retinitis Pigmentosa in SW USA Hispanics

MedicalResearch.com Interview with:

Stephen P. Daiger, PhD TS Matney Professor of Environmental and Genetic Sciences Human Genetics Center, School of Public Health and Mary Farish Johnston Distinguished Chair of Ophthalmology Ruiz Dept. of Ophthalmology and Visual Science The Univ. of Texas HSC at Houston

Dr. Daiger

Stephen P. Daiger, PhD
Professor, Human Genetics Center
Thomas Stull Matney, Ph.D. Professor in Environmental and Genetic Sciences
Mary Farish Johnston Distinguished Chair in Ophthalmology
The University of Texas Health Science Center at Houston

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Thanks for your questions about our research.  My research group and I have a long-term interest in finding genes and mutations causing inherited retinal diseases.  Our main focus is on retinitis pigmentosa (RP) and, more specifically, the autosomal dominant form of RP.

Inherited retinal diseases are progressive, degenerative diseases of the retina.  Onset can be very early in life, even at birth, or much later in life.  As the degeneration develops an affected person may first experienced limited loss of vision, progressing to severe loss of vision, ending, in many cases, in legal or complete blindness.  About 300,000 Americans are affected by inherited retinal disease and 50% of these have RP.  RP, like most hereditary conditions, can be inherited in an autosomal dominant, autosomal recessive or X-linked fashion.

One of the surprising, and in some sense, disturbing findings in studying  retinitis pigmentosa is that mutations in many different genes can cause this disease.  We now know that mutations in more than 80 genes can cause RP and thousands of different mutations have been found in these genes.  With next-generations sequencing it is possible to find the cause of RP in from 50% to 80% of cases, depending on the underlying mode of inheritance.For example, in our research we can find the disease-causing mutation in about 75% of families with autosomal dominant RP.  Needless to say, a primary aim of our research is to find the cause in the remaining 25%.

In looking for the cause of retinitis pigmentosa in the remaining 25%, that is, those in whom mutations were not detected by earlier methods, we found a potential dominant-acting mutation in the arrestin-1 gene (gene symbol “SAG”) using whole-genome sequencing.  Molecular modeling suggests this mutation is damaging.  This was unexpected because previously-reported mutations in this gene were associated with Oguchi disease, a recessive retinal disease with symptoms distinct from RP.  On further testing our cohort of patients with autosomal dominant RP, we found this mutation in nearly 4% of families.  Even more surprisingly, when we looked closely at the affected families, and worked with our collaborators to test other patients, we discovered that all of the families with the dominant-acting SAG mutation — 12 total — were of Hispanic origin.  By interviewing informative family members we learned that these families have their roots in the Southwestern United States.  Historically, the mutation may have arisen hundreds of years ago, consistent with genetic variation tracking with the mutation.

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Lithium Use in Pregnancy and Risk of Fetal Cardiac Malformations

MedicalResearch.com Interview with:

Elisabetta Patorno, MD, DrPH Assistant Professor of Medicine, Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital

Dr. Patorno

Elisabetta Patorno, MD, DrPH
Assistant Professor of Medicine, Harvard Medical School
Division of Pharmacoepidemiology and Pharmacoeconomics,
Department of Medicine, Brigham and Women’s Hospital

MedicalResearch.com: What is the background for this study?

Response: Lithium, a widely used medicine to treat bipolar disorder, has been associated with a 400 fold increased risk of Ebstein’s anomaly, a congenital malformation of the heart, and a 5 fold increased risk of cardiac defects overall in infants when taken early in pregnancy, based on the results from the International Register of Lithium Babies in the 1970’s. Beyond this data, most of the information on the safety of lithium during pregnancy accumulated in the last 40 years is based on case reports and small studies with conflicting results. Despite these concerns and the limited information, lithium remains a first-line treatment for the 1% of women of reproductive age with bipolar disorder in the U.S. population, due to its recognized efficacy during pregnancy and the postpartum period, and due to the presence of a larger body of evidence showing increased risk of congenital malformations for other mood stabilizers, such as valproate.

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Phase I Study Shows IV Gene Therapy May Improve Macular Degeneration

MedicalResearch.com Interview with:

Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD

Dr. Campochiaro

Prof Peter A Campochiaro MD
Director, Retinal Cell and Molecular Laboratory
Professor of Ophthalmology
Johns Hopkins University School of Medicine
Baltimore, MD

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients with wet age-related macular degeneration (AMD) have increased levels of vascular endothelial growth factor (VEGF) in their eyes resulting in growth of abnormal blood vessels that leak fluid into the retina and reduce vision. The current treatment is to inject proteins that block VEGF which initially provides a very good effect, but repeated injections are needed.

Patients sometimes are unable to keep up the frequency of visits and injections needed to keep the disease quiet and over time there is often gradual loss of vision. The aim of this study was to test a new approach through which a viral vector is injected into the eye resulting in production of a protein that block VEGF in the eye reducing the need for repeated injections.

These are the major findings:

1) Intravitreous injection of an AAV2 vector expressing a protein that blocks vascular endothelial growth factor (VEGF) was safe and well-tolerated.

(2) 5 of 10 patients injected with the highest dose (2 × 10¹⁰ vector genomes) had measurable levels of the therapeutic protein in samples removed from the front of the eye- all of these patients had no or very low levels of anti-AAV2 serum antibodies and 4 of the 5 patients who did not show expression had high anti-AAV2 serum antibodies

(3) Eleven patients had fluid in or under the retina before vector injection and 6 of them showed substantial reduction of the fluid which is the desired outcome.

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New Technology May Allow Topical Delivery of Anti-VEGF Drugs For Macular Degeneration

MedicalResearch.com Interview with:

Dr Felicity de Cogan PhD</strong> Institute of Inflammation and Ageing University of Birmingham

Dr Felicity de Cogan

Dr Felicity de Cogan PhD
Institute of Inflammation and Ageing
University of Birmingham

MedicalResearch.com: What is the background for this study?

Response: The University of Birmingham has a unique approach to developing technologies. By locating chemists, engineers, biologists and clinicians in the same department it revolutionised the way research problems are solved.

Initially, Felicity de Cogan was researching cell penetrating peptides (CPP) and their uses in microbiology. However, after joining forces with Neuroscientists, Dr Lisa Hill and Professor Ann Logan at the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) together with the clinicians and Vision Scientists, Dr Mei Chen and Professor Heping Xu at the Queen’s University Belfast it became evident that there was huge potential to deliver drugs in the eye. This was the start of the project and it developed rapidly from there.

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Gene Delivered By Nanoparticle System Can Potentially Cure Congenital Blindness

MedicalResearch.com Interview with:
Zheng-Rong Lu, Ph.D.

M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering
Department of Biomedical Engineering
Case Western Reserve University
Cleveland, OH 44106

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Genetic vision disorders are a major cause of severe vision loss and blindness, especially in children and young adults. Currently, there are no approved therapies to treat these types of disorders.

This study focused on one such disease known as Leber’s congenital amaurosis type 2 (LCA2). Patients with LCA2 are born with some degree of vision loss, and are often legally blind by early adulthood. LCA2 is a recessive disease caused by a mutation in one of the genes responsible for visual processing. LCA2 is a good candidate for gene therapy, and clinical trials underway to test viral vectors that deliver a healthy copy of the mutated gene into the eye have demonstrated considerable therapeutic efficacy. These trials have validated the feasibility of gene therapy to treat this disease, however viral vectors are limited by potential safety issues, complex preparation methods, and limitations on the size of genes that can be delivered.

In this study, we successfully treated LCA2 in mice for 120 days by delivering the gene responsible for LCA2 in a synthetic lipid nanoparticle instead of a viral vector. Our delivery system, called ECO, specifically targets the cells in the retinal pigmented epithelium, where the mutation behind LCA2 occurs. Our nanoparticle delivery system is easy to produce, safe, and has unlimited cargo capacity. Most important, our nanoparticle gene delivery system is a platform that can be used to deliver any gene into the retina, opening the door for safe and effective gene therapy for any genetic vision disorder.

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Study Compares Systemic Therapy vs Ocular Implant For Uveitis

MedicalResearch.com Interview with:

John H Kempen, MD, PhD Protocol Chair, MUST Trial Follow-up Study; Vice Chair, MUST Research Group Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear Harvard Medical School Editor-in-Chief, Ophthalmic Epidemiology President, Sight for Souls

Dr. Kempen

John H Kempen, MD, PhD
Protocol Chair, MUST Trial Follow-up Study; Vice Chair, MUST Research Group
Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear
Harvard Medical School
Editor-in-Chief, Ophthalmic Epidemiology
President, Sight for Souls

MedicalResearch.com: What is the background for this study?

Response: Uveitis is about the fifth leading cause of blindness in the united states.  Among types of uveitis, intermediate, posterior and panuveitis are the leading causes of blindness.  Before 2005, systemic therapy with corticosteroids—supplemented when indicated with immunosuppressive drugs (most of the time)—was the primary treatment recommended for these conditions.  With approval of the fluocinolone acetonide implant in 2005 for intermediate, posterior and panuveitis, it became unclear which of the alternative treatment approaches should be the treatment of choice.

The multicenter uveitis steroid treatment (must) trial was initiated in 2005 to directly compare the alternative treatments.  Systemic therapy was administered using high dose prednisone followed by tapering of corticosteroids to maintenance doses of 10 mg/day or less (generally 7.5 mg/day or less) or to zero; this was supplemented by immunosuppressive corticosteroid-sparing drugs in 88% of participants.  Implant therapy was done by initial quieting of the anterior chamber of the eye with topical, injected or systemic corticosteroids followed by surgical implant placement within 28 days (first eye) and 56 days (second eye if it was indicated).  After this, systemic corticosteroids and immunosuppressive drugs were tapered off.

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Number of Preschool Children With Visual Impairment Projected To Rise

MedicalResearch.com Interview with:

Rohit Varma, MD, MPH</strong> Executive Director - USC Roski Eye Institute and Dean of the Keck School of Medicine of USC

Dr. Varma

Rohit Varma, MD, MPH
Executive Director – USC Roski Eye Institute and
Dean of the Keck School of Medicine of USC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Visual impairment in early childhood has profound impact on a child’s development. It can significantly impair development of visual, motor, and cognitive function1-3 and lead to adverse psychosocial consequences. There has been a lack of accurate data characterizing the current and expected numbers of visual impairment cases among preschool children in the United States from 2015 to 2060.

The number of preschool children with visual impairment is projected to increase by 26% in 2060. And 69% of these visual impairment will result from simple uncorrected refractive error such hyperopia and myopia, which can be prevented or treated by low-cost refractive correction.

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Age-related Macular Degeneration Underdiagnosed in Primary Care

MedicalResearch.com Interview with:

David C Neely, MD The University of Alabama at Birmingham

Dr. Neely

David C Neely, MD
The University of Alabama at Birmingham

MedicalResearch.com: What is the background for this study? What are the main
findings?

Response: This study examined the prevalence of eyes with age-related macular degeneration (AMD) in patients seen in primary eye care clinics who purportedly have normal macular health.

Approximately 25.0% of eyes deemed to be normal based on dilated eye examination by primary eye care providers had macular characteristics that indicated age-related macular degeneration. Continue reading

CRISPR Gene Editing May Lead To Cure For Retinitis Pigmentosa

MedicalResearch.com Interview with:

Kang Zhang, M.D., Ph.D.</strong> Professor of Ophthalmology Chief, Ophthalmic Genetics Founding Director, Institute for Genomic Medicine Co-Director, Biomaterials and Tissue Engineering, Institute for Engineering in Medicine Board Certification in Ophthalmology Fellowship in Vitreoretinal Disease and Surgery Guangzhou Women and Children's Medical Center Guangzhou Medical University Guangzhou China

Dr. Kang Zhang

Kang Zhang, M.D., Ph.D.
Professor of Ophthalmology
Chief, Ophthalmic Genetics
Founding Director, Institute for Genomic Medicine
Co-Director, Biomaterials and Tissue Engineering, Institute for Engineering in Medicine
Board Certification in Ophthalmology
Fellowship in Vitreoretinal Disease and Surgery
Guangzhou Women and Children’s Medical Center
Guangzhou Medical University
Guangzhou China
MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Retinitis pigmentosa is a common blinding condition characterized by mutations in rod photoreceptor specific genes, night blindness and tunnel visual with eventual loss of day vision. Since it can be caused by numerous different mutations in many genes therefore it has been difficult to provide treatment benefits to a majority of patients. Traditional gene therapy has been in a piece-meal fashion, meaning to create a therapy for a particular gene or mutation. In this paper, we describe a universal gene therapy approach using the latest gene editing technology CRISPR/CAS9 to reprogram rod photoreceptors to cone photoreceptors with reversal of RP and restoration of vision.

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Outbreak of Severe Fungal Eye Infections Linked To IV Opioid Epidemic

MedicalResearch.com Interview with:
Aubrey Tirpack, PGY3

New England Eye Center
Tufts Medical Center 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Intravenous drug abuse is a known risk factor for the development of endogenous fungal endophthalmitis (EFE), a severe intraocular infection cause by the seeding of mycotic organisms to the eye.

Our institution noted a marked increase in cases of EFE beginning in May 2014, which correlates to increasing rates of opioid abuse throughout the New England region. Ten patients were found to have intravenous drug abuse related EFE over the two year time period studied. The most common presenting symptoms were floaters, decreased vision, and pain. All patients were treated with systemic antifungals and nine patients underwent intravitreal antifungal injection. All patients were ambulatory at presentation and the majority were without systemic signs of infection.

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Frequency of Retinal Screening in Diabetes May Be Tailored to Individual

MedicalResearch.com Interview with:
John M. Lachin, Sc.D.
Research Professor of Biostatistics and of Epidemiology, and of Statistics
The George Washington University Biostatistics Center and
David Matthew Nathan, M.D.
Professor of Medicine, Diabetes Unit
Massachusetts General Hospital 

MedicalResearch.com: What is the background for this study?

Response: Traditional guidelines for screening for retinopathy, based on indirect evidence, call for annual examinations. The automatic annual screening for retinopathy, without considering potential risk factors for progression,  appears excessive based on the slow rate of progression through sub-clinical states of retinopathy.

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Inhaling Poppers Associated With Visual Toxicity

MedicalResearch.com Interview with:
Dr. Rebecca Rewbury
Sussex Eye Hospital
Brighton and Sussex University Hospitals Trust
Brighton, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: ‘Poppers’ are recreational drugs which are illegal to sell for human ingestion, but are sold under the guise of household cleaning products. Inhalation leads to a brief sense of euphoria, enhanced sexual arousal and smooth muscle relaxation. The Psychoactive Substances Act 2016 was due to outlaw poppers, but they were excluded on the basis that they do not act directly on the central nervous system.

The main constituent of poppers, isopropyl nitrite, replaced isobutyl nitrite when the latter was classified as a carcinogen in 2006. Since then, there have been several case reports of ‘poppers maculopathy.’

We noted an increase in patients presenting with central visual disturbances after using poppers and describe 12 such cases. They all demonstrated similar disruption of the photoreceptor layer on retinal imaging. Onset of symptoms was frequently linked to specific brands of poppers, with 3 people having used poppers for many years and only developing side effects on changing brand. Chemical analysis showed that these products contained isopropyl nitrite. One brand of poppers, used without side effects by one patient, contained amyl nitrite, 2-methyl butyl nitrite and isobutyl alcohol, but no isopropyl nitrite.

The outcome of poppers maculopathy varied, but following abstention, visual disturbances and retinal damage tended to improve over months, if not fully resolve. Although in some cases, symptoms and/or imaging findings were prolonged. Ongoing use of implicated brands led to persistent, but not worsening maculopathy, whereas one patient that switched back to another brand showed full recovery.

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Vascular Safety of Ranibizumab in Patients With Diabetic Macular Edema

MedicalResearch.com Interview with:

Marco A Zarbin, MD, PhD, FACS Alfonse Cinotti, MD/Lions Eye Research Professor and Chair Institute of Ophthalmology & Visual Science Rutgers-New Jersey Medical School Rutgers University Newark, NJ 0710

Dr. Zarbin

Marco A Zarbin, MD, PhD, FACS
Alfonse Cinotti, MD/Lions Eye Research
Professor and Chair
Institute of Ophthalmology & Visual Science
Rutgers-New Jersey Medical School
Rutgers University Newark, NJ 0710 

MedicalResearch.com: What is the background for this study? What are the main findings?

  1. Most large, randomized clinical trials are powered to assess the efficacy of drugs or interventions, but they usually do not enroll enough patients to accurately assess the frequency of uncommon, undesirable side effects.
  2. In order to compensate for this deficiency in trial design, investigators aggregate the results of numerous studies all of which address the same clinical question with the same (or similar) drugs/interventions to increase the power to detect uncommon side effects. These aggregate studies can be meta-analyses.
  3. Unfortunately, most meta-analyses do not have the ability to answer some critical questions such as the timing of an adverse event relative to the last exposure to the drug, nor can they compensate fully for differences among the aggregated studies in trial design, length of patient follow-up, or presence pre-existing risk factors for the side effects in question.
  4. A pooled analysis of combined clinical trials using patient level data, however, allows a more in depth analysis of side effects than study level data, which are usually used for most published meta-analyses, because patient level data allow one to incorporate the per-patient duration of exposure to treatment, adjust for imbalances in predefined baseline risk factors, and adjust for the effect of results of single studies on the overall result.

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Economic Evaluation of a Home-Based Age-Related Macular Degeneration Monitoring System

MedicalResearch.com Interview with:
John Wittenborn

Senior research scientist
NORC’s Public Health Analytics
University of Chicago

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:The emergence of anti-VEGF treatment for wet-form AMD (choroidal neovascularization) has had a dramatic impact on preserving vision for many Americans. However, community-based studies show that most patients are not diagnosed with wet-form AMD until they have already lost a significant, and largely unrecoverable amount of their vision.  Early detection of wet-form AMD is key to effective treatment and the preservation of vision. The ForeseeHome telemonitoring technology provides patients with a means to check their own eyes on a daily basis to detect the earliest signs of vision loss from wet-form AMD.

This is a novel technology that has the potential to improve visual health outcomes for AMD patients.  A prior clinical trial (the AREDS-2 HOME study) demonstrated that this technology can detect wet-form AMD earlier, and with less vision loss than standard care alone. However, that is exactly where that study ended as it reported no cost information nor follow-up. Since the end of this study, the device has been cleared by the FDA and approved for reimbursement by Medicare for certain higher risk patients, but no study has yet considered the long-term implications of adoption of this technology.

In our analysis, we use a computer simulation model to essentially estimate what will come next, after patients realize earlier detection of wet-form AMD by utilizing home monitoring. Basically, we follow simulated patients from the time they begin monitoring for the rest of their lives, recording the likely impacts of home monitoring on patients’ long term outcomes including visual status, costs and quality of life.

We find that home telemonitoring among the population indicated for reimbursement by Medicare would cost $35,663 per quality adjusted life year (QALY) gained.  Medicare would expect to incur $1,312 in net budgetary costs over 10 years for each patient who initiates monitoring.  However, Medicare patients may expect to achieve lifetime net savings when accounting for the chance of avoided vision loss and its associated costs later in life.

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Diabetic Retinopathy: OCTA May Improve Staging, Diagnosis and Monitoring

MedicalResearch.com Interview with:

José Cunha-Vaz, M.D., Ph.D. Emeritus Professor of Ophthalmology University of Coimbra, Portugal President of AIBILI Association for Innovation and Biomedical Research on Light and Image Editor-in-Chief of Ophthalmic Research Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases, European Vision Institute Clinical Research Network (EVICR.net)

Dr. Cunha-Vaz

José Cunha-Vaz, M.D., Ph.D.
Emeritus Professor of Ophthalmology
University of Coimbra, Portugal
President of AIBILI
Association for Innovation and Biomedical Research on Light and Image
Editor-in-Chief of Ophthalmic Research
Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases,
European Vision Institute Clinical Research Network (EVICR.net) 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In this study, we evaluated the clinical utility of quantitative measures of microvasculature in optical coherence tomographic angiography (OCTA). Although several studies have demonstrated the potential value of measures of microvasculature in the management of diabetic retinopathy (DR), our study uses the ROC curve to compare the overall value of different approaches. In this age matched population with a range of disease, the mean vessel density measured in the SRL had the highest AUC, indicating that it is best among the methods tested at differentiating normal eyes from eyes with diabetic retinopathy.

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Transplanted Human Embryonic Stem Retinal Pigment Cells Survive 22 months in a Human Recipient

MedicalResearch.com Interview with:

Won Kyung Song MD.PhD Assistant Professor, Vitreoretinal service, Department of Ophthalmology CHA Bundang Medical Center CHA University Republic of Korea

Dr. Won Kyung Song

Won Kyung Song MD.PhD
Assistant Professor, Vitreoretinal service, Department of Ophthalmology
CHA Bundang Medical Center CHA University
Republic of Korea 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The retina is a light-sensitive neural tissue lining the inner surface of the human eye. The center of this retina is called the “macula”, which is responsible for high quality vision and central visual field. Retinal pigment epithelium is a layer of cells in the outer layer of the retina which has a critical role in maintaining and supporting the retina, especially the macula.

Age-related macular degeneration(AMD) is the leading cause of vision loss in the elderly in Western countries. There are two types of AMD, wet (neovascular or exudative) and dry (atrophic). The retinal pigment epithelium and choroid, are closely related with the pathophysiology of AMD. In dry AMD, age-related degeneration of RPE cells leads to the loss of photoreceptor cells and visual deficit. Currently, some therapies are available for ameliorating the wet AMD. However, there are no effective therapy available for dry AMD.

Previous studies have shown that healthy RPE cells can be implanted to replace unhealthy RPE cells in lesion areas where RPE cells have been lost. Allogenic RPEs resulted in graft rejection and autologous RPEs are difficult to harvest leading to surgery related complications. Now, abundant RPEs with stable genotype and phenotye may be generated from embryonic stem cells. Therefore, we have undergone subretinal transplantation of human embryonic stem cell derived RPE cells. (Clinicaltrials.gov NCT 01674829) Among the patients enrolled for

this clinical trial, we noted epiretinal membrane(ERM) with pigmentations over the retina in a proportion of patients as an adverse event. One patient with dry AMD and an epiretinal membrane after the hES-RPE transplantation undergone removal of this ERM. The histologic examination of this ERM with pigmentations showed that the pigmented cells originated from the transplanted hES-RPE cells which survived in the recipient for 22 months without anaplasia.

MedicalResearch.com: What should readers take away from your report?

Response: The main concerns of clinical application of hES derived cells are tumorigenesis and immune rejection.

There are limitations of these trials lacking confirmative measurements of engraftment of the transplanted cells. Because biopsy of the retina results in focal loss of nurosensory retina and labelling the cells may cause additional clinical harm.

This is the first report showing that hES derived cells has survived upto 22 months in human organ without anaplasia and may form an ERM.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Objective measurement of engraftment is necessary, together with advancement of an objective visual function measurements.

MedicalResearch.com: Is there anything else you would like to add?

Response: The case reported in this journal is a finding from a patient enrolled in the clinical trial sponsored by CHAbiotech.Co,Ltd.

HI12C1794(A121941)

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Shim SH, Kim G, Lee DR, Lee JE, Kwon HJ, Song WK. Survival of Transplanted Human Embryonic Stem Cell–Derived Retinal Pigment Epithelial Cells in a Human Recipient for 22 Months. JAMA Ophthalmol. Published online February 09, 2017. doi:10.1001/jamaophthalmol.2016.5824

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Smaller and More Stable Than Stem Cells, Exosomes Can Preserve Retinal Cell Function

MedicalResearch.com Interview with:

Ben Mead, BSc, MRes, PhD Section of Retinal Ganglion Cell Biology Laboratory of Retinal Cell and Molecular Biology National Eye Institute, National Institutes of Health Bethesda, Maryland 20892

Dr. Ben Mead

Ben Mead, BSc, MRes, PhD
Section of Retinal Ganglion Cell Biology
Laboratory of Retinal Cell and Molecular Biology
National Eye Institute, National Institutes of Health
Bethesda, Maryland 20892

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Retinal ganglion cells (RGC) in the back of the eye transmit visual information to the brain, via long thread-like extensions called axons, which make up the optic nerve. Loss of these cells is the leading cause of irreversible blindness and can occur through trauma or degenerative diseases, such as glaucoma or optic neuritis. While no treatment yet exists to directly protect RGC from death, mesenchymal stem cells, a type of stem cell isolated from adult bone marrow, have shown therapeutic efficacy in various animal models and are currently undergoing clinical trials.

In this study, we aimed to isolate exosomes, which are small, membrane-enclosed vesicles secreted by bone marrow stem cells (BMSC) and that we believe are associated with the therapeutic effect of BMSCs. Injecting these exosomes into the eyes of animals following an optic nerve injury, was associated with significant neuroprotection of RGC, as well as preservation of RGC function. The protective effects of exosomes appeared to be through their delivery of microRNA, molecules that interfere with or silence gene expression.

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Regular Cannabis Use May Slow Down Visual Processing By Retina

MedicalResearch.com Interview with:
Dr Vincent Laprévote
Praticien Hospitalier (MD, PhD, HDR)
Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy
Centre Psychothérapique de Nancy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There was evidence in animal studies showing that cannabis use could impact visual processing, but lesser was known in humans.

We showed here an association between regular cannabis use and a delay in the later stage of visual processing in the retina.

MedicalResearch.com: What should readers take away from your report?

Response: Regular cannabis use may slightly slow down the early visual processing.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: We have to cautiously verify our result in a larger sample. We also have to explore if this delay is present in further stages of visual processing (i. e. in the brain) and has behavioral consequences. Dr Schwitzer also just begun new researches to verify if this delay is permanent or recedes with cannabis cessation.

MedicalResearch.com: Is there anything else you would like to add?

Response: Importantly, all the participants of this research were regular cannabis users before their participation to the study. We systematically proposed cannabis cessation solutions to the participants.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Schwitzer T, Schwan R, Albuisson E, Giersch A, Lalanne L, Angioi-Duprez K, Laprevote V. Association Between Regular Cannabis Use and Ganglion Cell Dysfunction . JAMA Ophthalmol. Published online December 08, 2016. doi:10.1001/jamaophthalmol.2016.4761

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Complement Genes Play Role in Age-Related Macular Degeneration

MedicalResearch.com Interview with:

dr-anneke-i-den-hollanderAnneke I. den Hollander, PhD
Department of Ophthalmology and Department of Human Genetics
Donders Institute for Brain, Cognition, and Behaviour
Radboud University Medical Center
Nijmegen, the Netherland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Age-related macular degeneration is caused by a combination of genetic and environmental factors. Rare genetic variants in the complement system have been described in AMD, but their effect remains largely unexplored. In this study we aimed to determine the effect of rare genetic variants in the complement system on complement levels and activity in serum.

MedicalResearch.com: What are the main findings?

Response: Carriers of CFI variants showed decreased FI levels, carriers of C9 Pro167Ser had increased C9 levels, while C3 and FH levels were not altered. Carriers of CFH and CFI variants had a reduced ability to degrade C3b, which for CFI was linked to reduced serum FI levels.

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FDA Reports on Patient Satisfaction With LASIX Procedure

MedicalResearch.com Interview with:

Malvina Eydelman, M.D. Division Director; Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health FDA.

Dr. Malvina Eydelman

Malvina Eydelman, M.D.
Division Director; Division of Ophthalmic and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and Radiological Health
FDA.

MedicalResearch.com: What is the background for this study?

Response: In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project aimed to develop a tool to determine the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients.

At the time we developed our project, there was a limited amount of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is a report of a condition experienced and reported by the patient, not the health care provider.

Most LASIK studies used tools, such as questionnaires, to assess visual symptoms, but only after the surgery. The Patient-Reported Outcomes with LASIK (PROWL) studies in the LQOLCP assessed visual symptoms both before and after their LASIK surgery to identify changes over time. The studies also measured the impact symptoms directly had on performing usual activities, which had not previously been done.

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Men and Women Evaluate Faces Differently

MedicalResearch.com Interview with:
Antoine Coutrot PhD

CoMPLEX
University College London
London, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The human face is central to our everyday social interactions. Recent studies have shown that while gazing at faces, each one of us has a particular eye-scanning pattern, highly stable across time. Although variables such as culture or personality have been shown to modulate gaze behavior, we still don’t know what shapes these idiosyncrasies.

Moreover, most previous observations rely on analyses of small-sized eye-position datasets, often from the WEIRD (western, educated, industrialized, rich, and democratic) population. Here we use a very large and diverse dataset (400+ participants from 58 nationalities) and show that among many observer characteristics, gender is the one that best explains the differences in gaze behaviour. When looking at faces, women are more exploratory than men and more biased toward the left side. We even trained a classifier able to infer the gender of observers only based on their gaze.

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New Imaging Technology Can Measure Potential for Vision Loss in Neurofibromatosis

MedicalResearch.com Interview with:

Marius George Linguraru, DPhil, MA, MB Principal Investigator Associate Professor of Pediatrics and Radiology George Washington University School of Medicine and Health Sciences Children’s National Health System Washington, DC

Dr. Marius George Linguraru

Marius George Linguraru, DPhil, MA, MB
Principal Investigator
Associate Professor of Pediatrics and Radiology
George Washington University School of Medicine and Health Sciences
Children’s National Health System
Washington, DC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Neurofibromatosis type 1 (NF1) is the most common cancer predisposition syndrome affecting the central nervous with an incidence of one in 3,000 births. Nearly one in five children with NF1 develops an optic pathway glioma (OPG), a low-grade tumor of the anterior visual pathway (i.e., optic nerves, chiasm and tracts). These tumors are not amenable to surgical resection and can cause permanent vision loss ranging from a mild decline in visual acuity to complete blindness. Only half of children with NF1-OPGs will experience vision loss, typically between 1 to 6 years of age. The other half will never lose vision or require treatment.

All previous studies have consistently demonstrated that the change in NF1-OPG size is not related to the clinical outcome. For example, the optic pathway glioma size may be stable or even decrease, yet the vision will decline. Alternatively, the OPG size may increase, yet the clinical outcome remains stable or even improves. As no imaging or clinical features can identify which children with NF1-OPGs will ultimately lose vision, clinicians struggle to follow these children and decide when to intervene.

We used quantitative imaging technology to accurately assess in magnetic resonance imaging (MRI) the total volume of OPGs in NF1. We also determined the retinal nerve fiber layer thickness in these children, a measure of axonal degeneration and an established biomarker of visual impairment. The results were outstanding, as we showed for the first time that the volume of an optic pathway glioma is indeed correlated with the likelihood of vision loss in children with Neurofibromatosis type 1.

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Rolex Winner PEEK Vision Allows Smartphone-Based Eye Exams In Resource Poor Settings

MedicalResearch.com Interview with:
Dr. Andrew Bastawrous, Ophthalmologist

Rolex Awards for Enterprise
United Kingdom

Dr. Bastawrous’ smartphone-based portable eye examination system, Peek Vision, allows patients in low resource setting, to be screened for vision problems and eye diseases, enabling accurate diagnosis and treatment.

MedicalResearch.com: What is the background for Peek Vision? What are the main findings of your work with this system?

Response: Mama Paul has been blind for almost 20 years, most of her time is spent within the safety of her tiny home. It is basic, but in her mind’s eye she can still picture where the door is, her son – Paul, lives next door and is always willing to help.

Losing sight is the sense most people fear losing most.

I am severely visually impaired, I am also fortunate to have perfect vision when wearing corrective glasses or contact lenses and privileged to be in the profession of ophthalmology where centuries of research and practice have brought us to a time when so much of blindness is now curable or preventable.

There is no feeling like it: when the eye patch comes off someone who hasn’t seen for years, the sheer wonder as they take in their surroundings and their anticipation to see faces that have become voices and places that have become memories.

Back in 2011, as I pondered and planned for the challenges that lay ahead of us in Kenya, I had the continual thought that there must be an easier way to reach people, a way that is less expensive, less resource hungry and therefore could be used on a much wider scale.

In Kenya, and much of Africa, more people have access to a mobile phone than they do clean running water. It had to be possible to harness this connectivity.

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OCT of Retinal Lesions in Infants with Congenital Zika Syndrome

MedicalResearch.com Interview with:
Camila Ventura MD
Pediatric Retina Research Fellow at Bascom Palmer Eye Institute (BPEI), USA
PhD student at Federal University of São Paulo (Unifesp)
Medical Retina, Ocular Oncology, and Uveitis Department at Altino Ventura Foundation Brazil

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Brazilian outbreak of Zika virus (ZIKV) began in April 2015 and since then, we have not been able to stop its rapid spread throughout the Americas. Not only has ZIKV been disseminating very rapidly, patients affected by the ZIKV have also been presenting with some findings never before reported in the literature. Until recently, ZIKV infection was only associated with mild symptoms such as headache, rash, arthralgia, and conjunctivitis. However, in October 2015, a twenty-fold increase in the prevalence of newborns with microcephaly was reported that was later confirmed to be associated to ZIKV infection during pregnancy.

Although microcephaly and other central nervous system findings were the first abnormalities reported, recent publications have described other malformations associated with ZIKV congenital infection including hearing loss, limb anomalies and ocular findings. Due to all of these systemic findings, this new clinical condition has been named Congenital Zika Syndrome (CZS).

In January 2016, our group published the first report on the ocular findings of infants with microcephaly and presumed congenital ZIKV infection, followed by another manuscript describing 10 additional cases. We have also contributed with an article published in JAMA Ophthalmology reporting the risk factors associated to the ocular findings in babies with CZS. Other authors such as De Paula Freitas et al and Miranda 2nd et al, have also contributed to the literature by describing similar ocular findings in these infants with CZS.

In the present case series, we describe the Ocular Coherence Tomography (OCT) findings in ten eyes of eight infants with CZS.

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Action Video Games Improved Amblyopia In Two Weeks

MedicalResearch.com Interview with:
Krista 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?

Response: Amblyopia is one of the most common causes of monocular impairment in children, affecting 1 or 2 children in every US classroom. Patching of the fellow eye has been used for decades to improve visual acuity in the amblyopic eye. But patching does not always restore normal vision and does not teach the two eyes to work together. A novel technique originally designed by Drs Robert Hess and Ben Thompson at McGill University that works to reduce interocular suppression by rebalancing the contrast between the eyes has shown promising results in amblyopic adults. Dr Eileen Birch at the Retina Foundation of the Southwest worked with Dr Hess to adapt this contrast re-balancing approach to an iPad game platform suitable for children. Her research showed that the games were successful in improving visual acuity in amblyopic children as well. However, these initial games were rudimentary and resulted in low compliance.

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Some Children Find It Difficult To Wear Glasses During Lazy Eye Treatment

MedicalResearch.com Interview with:
Dr Gail Maconachie PhD
and
Researcher and
Professor Irene Gottlob
Professor of Ophthalmology
Dept. of Neuroscience, Psychology and Behaviour
The University of Leicester Ulverscroft Eye Unit
Leicester Royal Infirmary
Leicester UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Lazy eye (Amblyopia) affects 3-5% of the population. Treatment usually involves wearing glasses alone for around 18 weeks followed by occlusion of the good eye, usually a patch. Recent studies have shown, using monitors, that children often struggle with patching and patch only about half of what is prescribed. To date, no study has observed how well children with lazy eyes comply with glasses wearing. Glasses wearing is becoming increasingly important in lazy eye treatment as it has been shown to improve vision without other treatments. Therefore observing compliance may help to understand why some children do better with glasses treatment than others.

We found in our subjects that adherence to glasses wearing, in children aged 3 to 11 years who are undergoing treatment for a lazy eye, very variable and often poor. We also found that during treatment when only glasses wearing were given, adherence to glasses wearing, along with age and cause of the lazy eye, significantly predicted visual outcomes.

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Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial

MedicalResearch.com Interview with:

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

Dr. Pravin Dugel

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.  Continue reading

Payments to Ophthalmologists for Anti-VEGF Agents

MedicalResearch.com Interview with:

Aleksandra Rachitskaya, MD  Assistant Professor of Ophthalmology Retina Service, Department of Ophthalmology Cole Eye Institute Cleveland, OH 44195

Dr. Aleksandra Rachitskaya

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.

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Resistant E. Coli Produces Slimy Coating To Prevent Removal By Immune System

MedicalResearch.com Interview with:

Dr. Daria Van Tyne, PhD The Gilmore Lab Department of Ophthalmology Harvard Medical School, Massachusetts Eye and Ear Infirmary Boston, Massachusetts

Dr. Daria Van Tyne

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.

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90% of Americans Live Within Short Driving Distance To Eye Care

MedicalResearch.com Interview with:

Dr. Cecelia Lee

Dr. Cecelia Lee

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.

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Building Better Eyedrops For Drug Delivery

MedicalResearch.com Interview with:

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

Dr. Heather Sheardown

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.

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Contact Lens Infections Are Often Preventable With Proper Care

MedicalResearch.com Interview with:

Dr. Jennifer Cope MD, MPH Medical Epidemiologist CDC

Dr. Jennifer Cope

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.

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Stroke Risk Elevated in Some Patients with NAION

MedicalResearch.com Interview with:

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

Dr. Rong Kung-Tsai

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.

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Young Children At High Risk of Chemical Eye Burns

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

Dr. R. Sterling Haring

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.

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Sedentary Lifestyle Linked To Increased Risk of Diabetic Retinopathy

MedicalResearch.com Interview with:

Paul Dinneen Loprinzi, PhD Health, Exercise Science and Recreation Management University of Mississippi

Dr. Paul Loprinzi

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.

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Patient Satisfaction with LASIK Surgery For Nearsightedness Exceeded Contact Lenses Over Three Year Period

MedicalResearch.com Interview with:

Marianne Price, Ph.D. Executive Director Cornea Research Foundation of America Indianapolis, Indiana

Dr. Marianne Price,

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.

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“Big Data” in Ophthalmology Clarifies Epidemiology of Rare Eye Disorders

MedicalResearch.com Interview with:

Jeffrey R. Willis, MD, PhD University of California Davis Eye Center Sacramento, CA

Dr. Jeffrey Willis


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.

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Hands-Free Cellphone Use While Driving Also Delays Reaction Times

MedicalResearch.com Interview with:
Jeff C. Rabin, O.D., M.S., Ph.D., F.A.A.O., Dipl. Vision Science
Professor and Assistant Dean for Graduate Studies, Research and Assessment
Chief, Visual Neurophysiology Service
University of the Incarnate Word Rosenberg School of Optometry
San Antonio, TX

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Rabin: The use of hand-held cellphones during driving has been widely banned but the impact of hands-free communication on visual performance remained unclear. Therefore, we used a standard automobile Bluetooth device suspended above our visual display and determined that hands-free communication significantly delayed response time to detect low contrast black-white and color targets. Moreover, hands-free communication decreased sensitivity of “color-blind” subjects to detect targets corresponding to their color deficiency and all subjects showed a tendency for decreased sensitivity for detection of small, low contrast black-white targets.
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Severe Diabetic Macular Edema: EYLEA® Had Better Outcomes Than Avastin® or Lucentis® At One Year, But at Much Greater Cost

Adam Glassman, M.S. Director, DRCRnet Coordinating Center Jaeb Center for Health Research Tampa, FL 33647

Adam Glassman

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.

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