Optometric Nutrition Society (ONS) Inaugural Symposium at Academy Meeting
Academy Fellow and nationally recognized continuing education speaker and Research Chair of ONS, Stuart Richer, OD, MS, PhD, FAAO, provides a brief summary of the activities of the inaugural meeting of the newly formed ONS. The group met at the Academy meeting in Anaheim in October 21, 2008. This was the first annual COPE approved, nutrition science education symposium. It is modeled after the Optometric Retina and Glaucoma Societies. Jeffrey Anshel, OD, FAAO, is their first president. Dr. Richer reports, “We offer private practitioners, scientists, and educators a forum for education and collegial discussion concerning all aspects of nutrition’s effects on vision and eye health. With great initial corporate sponsorship, our bylaws disallow ONS from endorsing any particular product. Nor do we accept membership from any pyramid multi-marketing entity.”
The meeting was opened by Dr Anshel with a lecture on the current micronutrient RDA/DRI (dietary recommended allowances) and the consensus safe upper level established by the food and nutrition board of the Institute of Medicine. The following lecture by Steve Whiting, PhD, concerned the importance of full spectrum nutrition and the benefit of repletion of an entire array of known vitamins, minerals, and nutrients. Dr. Stuart Richer next spoke on the role of inflammation in ocular retinal disease. In the afternoon, Bruce Ames, PhD, an internationally renowned (Ames Test) UC Berkeley professor gave the keynote address. He spoke on mitochondrial delay with age due to oxidation of RNA/DNA, proteins, and lipids as a major contributor to aging and the degenerative diseases of aging. Dr. Ames amplified Dr. Whiting’s view concerning the bodies need for appropriate intake of a wide array of micronutrients and metabolites which vary with age and genetics. Larry Alexander, OD, FAAO, focused on nutrients and neuro-protection and its potential role in ameliorating glaucoma and macular degeneration. Dr. Anshel, in the final presentation, emphasized the role of nutrition in the primary eye care practice on a daily basis.
For more information: www.optometricnutritionsociety.org.
2008 EFCLIN Award Presented to Academy of Optometry’s Joseph Barr
Academy Fellow and Diplomate in Contact Lenses, Joseph Barr, OD, MS, FAAO, (vice president, Global Clinical & Medical Affairs and Professional Services, Vision Care for Bausch & Lomb) has been named the 2008 recipient of the prestigious European Federation of the Contact Lens Industry (EFCLIN) Award for his outstanding contributions to the contact lens industry.
EFCLIN, whose membership includes international contact lens manufacturers and suppliers, champions education and maintenance of the highest level of professional services within the contact lens industry. Each year EFCLIN recognizes a dedicated individual whose selfless contributions have made a lasting and positive effect on the industry. Academy Fellow Dr. Barr was chosen specifically for his continued commitment to education, and for his many professional publications and lectures by which he has advanced the fitting of contact lenses.
Dr. Barr has devoted his career to professional education as well as research and development. He is an emeritus professor of Optometry and Vision Science at The Ohio State University and was the director of the Collaborative Longitudinal Evaluation in Keratoconus Photography Reading Center. He has written more than 50 peer-reviewed publications related to contact lenses and the cornea. He previously served as chair of the Section on Cornea and Contact Lenses of the American Academy of Optometry.
ORGANIZATION & INSTITUTION NEWS
NEI Releases Complete Data from Age-Related Eye Disease Study
The National Eye Institute (NEI), part of the National Institutes of Health (NIH), announced the release of more than 10 years of data collected during the Age-Related Eye Disease Study (AREDS), which looked at the progression of age- related macular degeneration and age- related cataract in 4,757 adults aged 55 to 80.
Researchers around the world can apply for access to this complete set of medical history records and clinical trial results as well as select genetic information to gain a better understanding of two complicated vision conditions that affect aging adults.
“This vast pool of data is now at the fingertips of scientists, which is an unprecedented occurrence in the field” said Frederick L. Ferris III, MD, clinical director of the NEI. “Now that the entire AREDS database is available to the global research community, we hope that researchers will be inspired to delve more deeply into analyzing the genetic and environmental factors involved in the onset and progression of age-related macular degeneration and age-related cataract.”
The AREDS data are accessible through the online database of Genotypes and Phenotypes, known as dbGaP, which archives and distributes data from studies that explore the relationships between genetic variations (genotypes) and observable traits (phenotypes).
The NEI-supported AREDS was one of two studies included in the December 2006 launch of dbGaP. The National Library of Medicine’s National Center for Biotechnology Information (NCBI) created and operates dbGaP, which includes two levels of access. Study descriptions and documents such as protocols can be found in the public, open-access section. In the controlled-access section, approved researchers can view genotype and phenotype data from individual AREDS participants, though the information is coded to protect patients’ identities.
The first version of controlled-access AREDS data became available through dbGaP in June 2007. It included selected phenotypic data and information gathered from a genome-wide scan of DNA samples collected from 600 AREDS participants. The updated version now incorporates the complete information obtained from all 4,757 AREDS participants during trial enrollment and follow-up visits, including data from photographs of the patients’ eyes and information regarding their nutritional intake, quality of life, and rates of illness and death.
“Providing this new set of AREDS data through dbGaP will benefit researchers worldwide who are investigating genetic factors in age-related macular degeneration and other conditions,” said David Lipman, MD, director of the NCBI. “AREDS was one of two founding studies in dbGaP, and its availability over the last year and a half has enabled many research teams to conduct their own analyses of these important data. We are delighted to have received, and to make available, this even more extensive set of data, further enhancing the possibilities for research and discovery.”
AREDS began in 1992 as a long-term, multi-center, prospective study designed to evaluate the progression of age-related macular degeneration and age-related cataract. Participants were also enrolled in a clinical trial of high-dose vitamin and mineral supplements. They were followed for a median of 6.5 years during the trial and an additional 5 years after the trial’s conclusion.
In addition, DNA was isolated from blood samples taken from more than 3,700 AREDS participants beginning in 1998. DNA from many of these participants is currently being stored in the NEI-AREDS Genetic Repository. Access to these DNA samples for research purposes is available for a fee through the Coriell Institute for Medical Research. “Genetic testing has become crucial in the advancement of science, both for understanding the progression of diseases and for determining appropriate research directions for treatments,” said Paul A. Sieving, MD, PhD, director of the NEI. “With the AREDS data available through dbGaP, vision researchers can continue to identify genetic factors that may play a role in eye conditions such as age-related macular degeneration and cataract.”
The public, open-access AREDS data can be viewed on the dbGaP website. Researchers can find a link to the application for controlled access to individual-level data on the same site. More information about AREDS (NCT00000145) can be found at www.clinicaltrials.gov.
NEI Says More Effective Treatment Identified for Common Childhood Vision Disorder
Clinical scientists have found a more effective treatment for a common childhood eye muscle coordination problem called convergence insufficiency (CI). In CI, the eyes do not converge easily, and as a result, additional muscular effort must be used to make the eyes turn in.
Although the majority of eye care professionals treat children diagnosed with CI using some form of home-based therapy, a new study concludes that office-based treatment by a trained therapist along with at-home reinforcement is more effective. The research, reported in the October 2008 issue of Archives of Ophthalmology, was funded by the NEI, part of the NIH.
The 12-wk study, known as the Convergence Insufficiency Treatment Trial (CITT), found that approximately 75% of those who received in-office therapy by a trained therapist plus at-home treatment reported fewer and less severe symptoms related to reading and other near work. Symptoms of CI include loss of place, loss of concentration, reading slowly, eyestrain, headaches, blurry vision, and double vision.
“This NEI-funded study compared the effectiveness of treatment options for convergence insufficiency,” said Paul A. Sieving, MD, PhD, director of the NEI. “The CITT will provide eye care professionals with the research they need to assist children with this condition.”
The CITT, which included 221 children age 9 to 17, is the first to compare three forms of vision therapy and a placebo therapy option. The first therapy was the current treatment standard known as home-based pencil push-up therapy, an exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose. The goal was to keep the letter clear and single, and to stop if it appeared double. The second group used home-based pencil push-ups with additional computer vision therapy. The third attended weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises. The last group was given placebo vision activities designed to simulate office-based therapy.
After 12 wk of treatment, nearly 75% of children who were given the office-based vision therapy along with at-home reinforcement achieved normal vision or had significantly fewer symptoms of CI. Only 43% of patients who completed home-based therapy alone showed similar results, as did 33% of patients who used home-based pencil push-ups plus computer therapy and 35% of patients given a placebo office-based therapy.
“There are no visible signs of this condition; it can only be detected and diagnosed during an eye examination,” said principal investigator Mitchell Scheiman, OD, FAAO of Pennsylvania College of Optometry at Salus University near Philadelphia, PA. “However, as this study shows, once diagnosed, CI can be successfully treated with office-based vision therapy by a trained therapist along with at-home reinforcement. This is very encouraging news for parents, educators, and anyone who may know a child diagnosed with CI.”
A 12-mo follow-up study is being conducted to examine the long-term effects of these CI treatments. Further information about the reported trial, NCT 00338611, can be found at www.clinicaltrials.gov.
Neuroscience and the NEI: Vision Research Presentations at Neuroscience 2008
On November 15 to 19, 2008 (Washington DC), researchers supported by the NEI, as well as researchers working on-site at NEI, presented recent advances in vision science at the Society for Neuroscience Annual Meeting. Topics included stem cells, visual processing, and vision’s role in decision making. Vision scientists demonstrated the interdisciplinary impact of their work by presenting the latest NEI-funded neuroscience research findings.
Anti-VEGF Drugs for Retinal Diseases Could Have Serious Side Effects, Scientists Caution
Scientists at Schepens Eye Research Institute report that reducing the levels of vascular endothelial growth factor (VEGF), which is best known as a stimulator of new blood vessel growth, in adult mice causes the death of photoreceptors and Muller glia—cells of the retina that are essential to visual function. This finding, published in the November 3, 2008 PLoS ONE, holds implications for the chronic use of promising new anti-VEGF drugs such as Lucentis, which eliminate abnormal and damaging blood vessel growth and leakage in the retina by neutralizing VEGF.
“The take home message of this study is that physicians should be vigilant in monitoring patients undergoing anti-VEGF treatments for any possible signs of these side effects,” says Principal Investigator Patricia D’Amore, Senior Scientist at Schepens Eye Research Institute. “Drugs such as Lucentis are very good at reducing the edema (fluids) and eliminating the abnormal blood vessels that characterize wet macular degeneration, but our results suggest that there could be unanticipated side effects.”
However, a growing body of evidence also indicates that beyond its impact on blood vessel growth, VEGF may play other vital roles in the adult body and eye, so that eliminating the growth factor might lead to unexpected consequences. Given the popularity and promise of the new anti-VEGF drugs for the treatment of macular degeneration, D’Amore and her team believed that investigating the broader role of this growth factor in the normal adult retina was critical. She and her laboratory mimicked the action of the anti-VEGF drugs by introducing into adult mice a soluble VEGF receptor, known as sFlt1, which binds and neutralizes the VEGF—in much the same way that Lucentis does in the eye.
“Insight into the complex role of VEGF in the eye and in other parts of the body indicates that increased care should be taken in the long-term use of these drugs and that this new information should be considered in the design of future clinical studies to ensure that these possible side effects are taken into account,” says D’Amore. “Mice eyes differ from human eyes in many ways, so we cannot directly extrapolate these results to humans, but this study is an important heads-up that clinical application of anti-VEGF therapy in the eye needs to proceed with caution,” she adds.
The study is also relevant to the drug Avastin, which was initially approved for intravenous use as an anti-angiogenic agent in the treatment of cancer, but is also widely used intravitreally for the treatment of wet AMD because of its similar mode of action and much lower cost. The next steps in D’Amore’s research will include investigating the specific functions of VEGF in the eye.
The Power of Medical Research Investment to Stimulate the Economy Short- and Long-Term
The National Alliance for Eye and Vision Research reports that in Mid November 2008, Senate Majority Leader Harry Reid (D-NV) and Senate Appropriations Committee Chairman Robert Byrd (D-WV) unveiled a $100.3 billion economic recovery package that includes $1 billion for the NIH. Whether this legislation moves through Congress in the lame duck, early in 2009 in the 111th Congress, or as a package to finalize Fiscal Year 2009 appropriations, the inclusion of NIH funding reflects an acknowledgment of the return on the investment at NIH.
At a late afternoon session on November 18, 2008, held by the Society for Neuroscience, former NIH Director Harold Varmus, MD (President and CEO, Memorial Sloan-Kettering Cancer Center, and science advisor to the Obama campaign) said that Congress now understands the short-term value of research grants- including salaries, indirect expenses with universities, supplies and equipment-to stimulate the economy, as well as the long-term return on investment, which he cited at 150%. Joining Dr. Varmus was Wendell Primus, PhD, who serves as the Senior Policy Advisor to House Speaker Nancy Pelosi (D-CA) and the Honorable John Porter (Hogan & Hartson), who serves as National Alliance for Eye and Vision Research’s Legislative Counsel. Dr. Primus predicted that “research would be treated well in the next Administration and Congress and that Speaker Pelosi is a true believer,” which was echoed by Mr. Porter, who previously served as Chair of the House Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee on which Speaker Pelosi formerly sat. John Porter noted that, in addition to increases to “bring NIH back to where it should be after the devastating impact of five cycles of flat funding and biomedical inflation,” NIH needs sustainable annual increases along the lines of 3%, plus the biomedical inflation rate (currently 3.5%).
SEVA Foundation Honors Pioneers in Preventable Blindness
Early in November 2008, the Seva Foundation honored the accomplishments of two pioneering leaders in the fight against preventable blindness around the world—Dr. Paul Courtright and Dr. Susan Lewallen. Dr. Courtright, an epidemiologist, and Dr. Lewallen, an ophthalmologist, are both on the faculty in the Department of Ophthalmology at the University of British Columbia. The Kilimanjaro Center for Community Ophthalmology (KCCO) in Tanzania, which Courtright and Lewallen established in 2001, opened its new three-story, 25,700 square-foot training center in Tanzania, at the base of Mt. Kilimanjaro. The center focuses on training, research and program development using local talent and skills, aimed at decreasing blindness across eastern Africa. “In a relatively short time, KCCO has grown to be the most active center dedicated to community ophthalmology in Africa, with trainees coming from countries across the continent,” said Dr. Suzanne Gilbert, cofounder of Seva Foundation and Director of Seva’s Center for Innovation in Eye Care. KCCO is a lead partner in their new Clinton Global Initiative campaign, “So One Million Eyes See Again.”
KCCO serves 18 countries from Cairo to Cape Town, directing critically needed projects and collaborations throughout eastern Africa, a region with a population of around 210 million. Working with a consortium of partner agencies and funders, KCCO strives to discover new and innovative methods to bring top-notch eye-care treatment and preventative services to surrounding rural communities. For more information about KCCO visit: <http://www.kcco.net/>www.kcco.net. For more information about Seva Foundation visit: <http://www.seva.org/> www.seva.org.
Implantable Telescope for End-Stage Macular
VisionCare Ophthalmic Technologies, a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), announced that the American Journal of Ophthalmology (AJO), has published 2-year results from the Phase II/III IMT002 trial showing substantial visual acuity improvement in End-Stage AMD patients. The study device, a first-of-kind implantable telescope, is under regulatory review by the US Food and Drug Administration (FDA). The company reports that the device is “smaller than a pea, (and this) telescope prosthetic device is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non- operated eye provides peripheral vision for mobility and orientation.” A Premarket Approval (PMA) application and subsequent PMA amendments have been submitted to the US FDA and are currently under regulatory review.
ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve
On November 13, 2008, ISTA Pharmaceuticals, announced the Company filed a New Drug Application with the US FDA for Bepreve (bepotastine ophthalmic solution). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. ISTA filed the Bepreve New Drug Application electronically, in eCTD format and using the FDA’s Electronic Submission Gateway. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of 10 months from date of receipt.
Topcon Announces New Developments
On November 14, 2008, Topcon Medical Systems, (TMS) introduced two new developments for its EyeRoute Image Management System. Newly available software, designed to “eliminate the staff time needed to store images, as well as to track them down when needed” will be loaded on any Topcon device that has a personal computer. Topcon’s goal is to have EyeRoute on all of its systems, as part of its mission, Connecting Visions. The second new development is EyeRoute Mobile. This new application enables EyeRoute users to access images on their handheld devices, just as long as the handheld is 3G compatible. As part of the EyeRoute Mobile package, an Apple iPhone is included.
FDA Grants Market Clearance for Use of Several Lens Care Products with SynergEyes Hybrid Contact Lenses
On November 7, 2008, SynergEyes, received US FDA market clearance for the use of the following lens care products with SynergEyes hybrid contact lenses: CIBA VISION′s AQuify Multi-Purpose, AMO’s COMPLETE Multi-Purpose Easy RubTM, AMO’s Oxysept UltraCare Formula Peroxide Disinfection System, and Bausch and Lomb’s ReNu MultiPlus Multi-Purpose.
CIBA VISION′s Clear Care and Alcon’s OPTI-FREE Express Multi-Purpose were granted FDA market clearance for use with SynergEyes lenses in September 2005. SynergEyes manufactures a contact lens that combines two materials—a rigid gas permeable center and a soft, hydrophilic outer skirt.