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EW WEEK No. 17
· Alcon’s Constellation Vision System recalled
· Hoya, Adoptics partner on accommodating IOLs
· NovaVision assets to be sold
· Generic Flomax granted approval
· ISCO, Insight Bioventures launch Indian subsidiary

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Red reflex test to all newborns recommended
Bepreve found effective for severe itching
Rituximab may help with severe Graves’ disease
Steroids helpful for DME
Retina tops online health forum inquiries
Laser eye surgery does not affect corneal cells
Cataract does not affect AMD progression
Longer replacement intervals leads to more ‘fudging’ CL replacement times
AMO recalls all lots of OVD Vitrax II
Volume 14, Number 32
November 16, 2009
Red reflex test to all newborns recommended
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Physicians at The Vision Center of Children’s Hospital, Los Angeles, are strongly advocating a basic eye exam, including a red reflex test, be given to all children shortly after birth, the center said. Angela Buffenn, M.D., M.P.H., Director of the Orbit and Eye Movement Institute and Diana Dennis, M.A. of the Therapeutic Living Center for the Blind, reported on the problem of inadequate childhood vision screenings in Pediatric News. The red reflex test involves looking at the infant's eyes through an ophthalmoscope in a dimly lit room to see if there are any abnormalities in the back of the eye or white spots in the eyeball. The test is used to screen for abnormalities in the eye itself as well as ocular misalignment. If the red reflex is found to be abnormal, the child should be examined by a pediatric ophthalmologist in order to test for strabismus (crossed eyes), cataracts, glaucoma, retinoblastoma, retinal abnormalities, and high refractive errors. Oftentimes, the test is first administered by a pediatrician or family physician. The red reflex test has been endorsed as an important part of a well child visit by the American Academy of Pediatrics and the American Academy for Pediatric Ophthalmology and Strabismus. "Too often we see children with developmental delay whose visual system has not been properly evaluated. Sometimes, parents also think that vision loss is less important than treating the seizure disorder or developmental disability, when the truth is we can address both at the same time," said Dr. Buffenn.

Bepreve found effective for severe itching
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Integrated results from two Phase III studies of bepotastine besilate ophthalmic solution 1.5% (Bepreve, Ista Pharmaceuticals, Irvine, Calif.) found the drug to be “as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching,” the company said in a news release.
A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled Conjunctival Allergen Challenge clinical studies (1 single site, 1 multi-site); 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades (placebo-active) for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat (ITT) population, Ista said. The results were presented during the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology in Miami Beach, Fla. Bepreve was approved by the U.S. Food and Drug Administration in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. Bepotastine has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and urticaria/pruritus since 2002.

Rituximab may help with severe Graves’ disease
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Rituximab, often used to treat autoimmune disorders, has shown efficacy in a small group of patients with severe Graves’ eye disease, researchers said. These patients experienced rapid improvement of their symptoms, improved vision, and “significant reduction” in inflammation around their eyes and optic nerve, the University of Michigan’s Kellogg Eye Center said in a news item. These patients had been steroid non-responders.
Raymond S. Douglas, M.D., Ph.D., had previously studied the six patients while on staff at University of California at Los Angeles. In the current study, Dr. Douglas observed improvement among the patients, four of whom were women, as early as 4 weeks following the first infusion of rituximab, the university said. Researchers also observed that the positive results were sustained 4 to 6 months after treatment.

Steroids helpful for DME
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For patients with diabetic macular edema (DME), intravitreal triamcinolone (IVTA) was able to improve vision in eyes that had continued to deteriorate despite receiving standard laser treatment, researchers at the University of Sydney, Australia, said in a university news item.  In the first three months after treatment, the patients initially treated with both IVTA and laser showed significantly better gains in vision than control group patients who were treated with laser only. After 2 years, patients in the original control group were also treated with IVTA. The beneficial effects persisted in most IVTA-treated patients throughout the 5-year study; however, 80% of patients in the initial IVTA group developed elevated intraocular pressure and 56% of them required therapy, the university said. Also, two-thirds of all patients required during the study period. Similar outcomes have been noted in other studies of steroid-based treatment and thus were not considered new safety concerns by the group.

Retina tops online health forum inquiries
Top

According to an analysis of questions asked on MedHelp, the American Academy of Ophthalmology’s health information Web site, concerns related to the retina topped the list—almost 20% of the 4,485 questions posed over a 6-month period from Sept. 2008 through March 2009. According to John C. Hagan, M.D., and colleagues, many people asked about or retinal detachment. About 19% of questions were related to the cornea. Cataract and implanted lens questions were next in prevalence, followed by brain-eye problems (neuro-ophthalmology), children’s eye alignment (), eye cancers, and general discomfort or blurry vision.
Two-to-three percent of questions related to each of three vision correction topics: refractive surgery . A smaller number were related to eye care products or medical insurance. The analysis also found many people submit postings to express their gratitude for the medical advice provided.

Laser eye surgery does not affect corneal cells
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Neither PRK nor LASIK appear to be associated with lasting changes to endothelial cells up to 9 years postoperatively, according to a news item from Archives of Ophthalmology, which published the study results.
Sanjay V. Patel, M.D., and William M. Bourne, M.D., of Mayo Clinic (Rochester, Minn.) studied 29 eyes of 16 patients who had undergone LASIK or PRK. Photographs of endothelial cells were taken and analyzed before and nine years after surgery. The annual rate of corneal endothelial cell loss in the eyes of patients who had had surgery was compared with those of 42 eyes that had not undergone either procedure.
Although the endothelial cell count had decreased by 5.3% from baseline at 9 years, the average annual rate of cell loss (0.6%) was the same in eyes that had undergone the surgery and those that had not. The authors note this could have an impact on the corneal suitability for posterior lamellar keratoplasty.
This study was supported by a grant from the National Institutes of Health, by Research to Prevent Blindness Inc., and by the Mayo Foundation.

Cataract does not affect AMD progression
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Age-related macular degeneration (AMD) does not appear to progress at a higher rate among individuals who have had surgery to treat cataract, contrary to previous reports that treating one cause of vision loss worsens the other, according to a study in Archives of Ophthalmology. Because both conditions are strongly age-related, many individuals with cataract also have AMD, the journal said in a news item. There has been a long-standing controversy among clinicians as to whether cataract surgery is contraindicated in eyes with non-neovascular AMD. A major concern has been whether cataract surgery increases the risk of progression to neovascular AMD in eyes at risk of progression such as those with intermediate AMD.
Li Ming Dong, Ph.D., of Stony Brook University School of Medicine, N.Y., and colleagues studied eyes of 108 individuals with non-neovascular AMD who underwent preoperative assessments for cataract surgery between 2000 and 2002. Photographs of the retina were taken and fluorescein angiography, which uses a special dye to investigate blood vessels in the eye, was performed. A total of 86 evaluated eyes had non-neovascular AMD before surgery, and 71 had follow-up assessments between one week and one year after surgery.
Neovascular AMD was observed in nine (12.7%) of these 71 eyes at one or more follow-up assessments. Five eyes displayed signs of neovascular AMD at the 1-week follow-up point; the size and location of the lesions identified indicated that they may have been present before surgery but not visible due to the opaque lens caused by cataract. When these eyes and one eye that did not have 1-week follow-up photographs available were excluded, the progression rate between 1 week and 1 year decreased to three of 65 eyes (4.6%). The rate of progression to neovascular AMD was similar among participants other, cataract-free eyes over the same time period (3%).
The authors do note earlier reports may be biased with the absence of immediate postop fluorescein angiography. An accompanying editorial notes the diversity in study findings may be due to study design and that much work is still needed before steadfast conclusions may be made.

Longer replacement intervals leads to more ‘fudging’ CL replacement times
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Contact lenses prescribed for longer replacement intervals can lead to more extreme over wear (stretching) that could lead to undesirable clinical effects, according to Vistakon (Jacksonville, Fla.). In a survey of frequent replacement contact lens wearers, more than half say they are not compliant with their prescribed replacement schedule, whether wearing a 2-week or monthly lens. A random sample of 645 frequent replacement contact lens wearers answered questions relating to lens replacement frequency, using an online, sponsor-masked survey. The respondents represented wearers of hydrogel and silicone hydrogel lenses available in the United States that are prescribed for 2-week or monthly replacement, Vistakon said in a news release. About four-in-ten (43%) wearers of 2-week replacement lenses said they replaced their lenses as prescribed. Sixty-five percent replaced them at 3 weeks; 85% within 4 weeks, 4% at 8 weeks or more, and 2% at 10 weeks or more. Only about one-third (36%) of monthly replacement lens wearers replaced their lenses as prescribed. Over half (55%) replaced them at 5 weeks, 23% at 8 weeks or more, and 14% at 10 weeks or more. Results of the study were presented at last week’s American Academy of Optometry meeting.

AMO recalls all lots of OVD Vitrax II
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Abbott Medical Optics (Santa Ana, Calif.) voluntarily recalled all lot numbers of Vitrax II (3% sodium hyaluronate) 0.65 mL last month after receiving notification the pH of the product in some syringes was out of specification. At the time of its recall letter to customers, AMO’s German office in Ettlingen (originators of the recall letter) said it had not received any complaints attributed to the pH of the ophthalmic viscosurgical device. AMO added that some studies have found pH levels of more than 8.5 in any given syringe may lead to endothelial cell damage.


EYEWORLD WEEK Online edited by David Laber and Enette Ngoei

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Monday, distributed by e-mail, and posted live on Monday mornings.

Chief Medical Editors: Stephen A. Obstbaum, M.D., and Stephen S. Lane, M.D.

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