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Volume 12, Number 12
Monday, March 19, 2012
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MARCH IS NATIONAL NUTRITION MONTH




In this issue: (click heading to view article)
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######### Affects of Visual Impairment, Age-related Eye Disease and Cognitive Function

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######### Need for Ranibizumab Retreatment of Neovascular AMD Monitored by Environmental Amsler Test
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######### Visual Outcomes of Diabetic Patients Following Phacoemulsification Cataract Surgery
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######### Variations in Age and Gender in AMD Prevalence in Certain Patient Populations
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Affects of Visual Impairment, Age-related Eye Disease and Cognitive Function

The following population-based, cross-sectional study of 1179 participants aged 60 to 80 years from the Singapore Malay Eye study was conducted to describe the associations of visual impairment and major age-related eye diseases with cognitive function in an older Asian population.

Visual acuity was measured using the logMAR vision chart and cataract and age-related macular degeneration (AMD) were graded using the Wisconsin Cataract Grading System and the Wisconsin Age-Related Maculopathy Grading System, respectively. Additionally, glaucoma was diagnosed using the International Society Geographical and Epidemiological Ophthalmology criteria and diabetic retinopathy was graded using the modified Airlie House classification system. Cognitive dysfunction was defined as a locally validated Abbreviated Mental Test using education-based cutoff scores.

After adjusting for age, sex, education level, income, and type of housing, persons with visual impairment before refractive correction (odds ratio [OR] = 2.59; 95% CI, 1.89–3.56) or after refractive correction (OR = 1.96; 95% CI, 1.27–3.02) and those with visual impairment due to cataract (OR = 2.75; 95% CI, 1.35–5.63) were more likely to have cognitive dysfunction. Only moderate to severe diabetic retinopathy was independently associated with cognitive dysfunction (OR = 5.57; 95% CI, 1.56–19.91) after controlling for concurrent age-related eye diseases. Furthermore, no significant independent associations were observed between cataract, AMD or glaucoma and cognitive dysfunction.

It was determined that older persons with visual impairment, particularly those with visual impairment due to cataract, were more likely to have cognitive dysfunction. Among the major age-related eye diseases, only diabetic retinopathy was associated with cognitive dysfunction.

SOURCE: Ong SY, Cheung CY, Li X, et al. Visual impairment, age-related eye diseases, and cognitive function: the Singapore Malay Eye Study. Arch Ophthalmol. 2012;March 12 [Epub ahead of print].




http://ecatalog.alcon.com/PI/Nevanac_us_en.pdf







Need for Ranibizumab Retreatment of Neovascular AMD Monitored by Environmental Amsler Test

Researchers in London sought to assess the ability of patients to predict the need for retreatment with intravitreal ranibizumab in neovascular age-related macular degeneration (NVAMD) based on their perception of visual deterioration or distortion of objects in their everyday environment (environmental Amsler).

They gave a questionnaire to 89 patients undergoing optical coherence tomography (OCT)-guided retreatment with intravitreal ranibizumab for NVAMD following an initial loading regimen of three injections and with at least 12-month follow up. Then they recorded the patient's opinion on the need for an injection on the current visit, based on their perception of change in environmental Amsler. The researchers compared this subjective measure with the objective evaluation of retreatment, based on predefined retreatment criteria comprising of changes in visual acuity and morphological changes on OCT. They then instructed the patients on the technique of environmental Amsler, and this evaluation was repeated. At baseline and after the training, they analyzed the sensitivity and specificity of patient prediction.

According to the researchers, the ability of patients to predict disease activity at baseline showed a sensitivity of 61% and specificity of 96.6%. They noted that the area under the receiver operating characteristic curve was 0.8 and that the presence of macular fluid correlated well with the patient's perception of an abnormal environmental Amsler. After training, the sensitivity and specificity improved to 87.5% and 98.5%, respectively.

In real life, most patients are able to predict the reactivation of the disease in NVAMD, after 12-month follow-up, after training to monitor their symptoms using the environmental Amsler test.

SOURCE: Mathew R, Sivaprasad S. Environmental Amsler test as a monitoring tool for retreatment with ranibizumab for neovascular age-related macular degeneration. Eye. 2012;26(3):389–393.



http://www.revophth.com/ResFellowEdu2012






Visual Outcomes of Diabetic Patients Following Phacoemulsification Cataract Surgery

The authors of the following Australian study followed 1,192 cataract surgical patients aged ≥65 for 12 months postoperatively to assess cataract surgery visual outcomes 12 months postoperatively in patients with diabetes, with or without diabetic retinopathy (DR), compared to patients without diabetes.

They took standardized pre- and postoperative pinhole LogMAR visual acuity (VA) measurements and determined VA improvement by comparing VA after 12 months to preoperative VA.

They reported that of 1,192 surgical patients, 324 (27.2%) had diabetes, of whom, 136 (42.0%) had DR. After adjusting for age, gender, diabetes duration and preoperative pinhole VA, the average VA gained 12 months after surgery was 10.8 letters among 868 patients without diabetes, 10.6 letters among 188 patients with diabetes but no DR, 10.0 letters among 95 patients with DR but no past laser treatment, and no letters among 41 patients with DR plus past laser treatment (p<0.0001, compared to the other three groups). The study authors associated diabetes duration ≥20 years with mean VA gain of 3 fewer letters than duration <10 years (7 versus 10 letters, p=0.023), after adjusting for age, gender, DR and preoperative pinhole VA.

To conclude, cataract surgery improved VA by an average two lines for patients both with and without diabetes, or with DR but no past laser treatment. No significant VA improvement was evident for patients who had preoperative DR and laser therapy.

SOURCE: Fong CS, Mitchell P, Rochtchina E, et al. Visual outcomes 12 months after phacoemulsification cataract surgery in patients with diabetes. Acta Ophthalmol. 2012;90(2):173–178.

 








Variations in Age and Gender in AMD Prevalence in Certain Patient Populations

In London, investigators aimed to obtain prevalence estimates of age-related macular degeneration (AMD; late, geographic atrophy, neovascular) by age and gender among populations of European ancestry taking into account study design and time trends.

They conducted a systematic review of population-based studies published by September 2010 with quantitative estimates of geographic atrophy (GA), neovascular (NV) and late AMD prevalence. They identified studies by a literature search of MEDLINE (from 1950), EMBASE (from 1980) and Web of Science (from 1980) databases. For their participants, they used data from 25 published studies (57,173 subjects: 455 with GA, 464 with NVAMD, and 1,571 with late AMD). The method used was Bayesian meta-regression of the log odds of AMD with age, gender and year of study allowing for differences in study design characteristics to estimate prevalences of AMD (late, GA, NVAMD) along with 95% credible intervals (CrI). Main outcome measures were log odds and prevalence of AMD.

The investigators reported that there was considerable heterogeneity in prevalence rates between studies; for late AMD, 20% of the variability in prevalence rates was explained by differences in age and 50% by study characteristics. They also noted that prevalence of AMD increased exponentially with age (odds ratio [OR], 4.2 per decade; 95% CrI, 3.8–4.6), which did not differ by gender. There was some evidence to suggest higher risk of NVAMD in women compared with men (OR, 1.2; 95% CrI, 1.0–1.5). The study investigators also found that compared with studies using fundus imaging and international classification systems, studies using fundus imaging with alternative classifications were more likely (OR, 2.7; 95% CrI, 1.1–2.8), and studies using alternative classifications without fundus imaging most likely to diagnose late AMD (OR, 2.9; 95% CrI, 1.3–7.8). There was no good evidence of trends in AMD prevalence over time. Estimated prevalence of late AMD is 1.4% (95% CrI, 1.0% –2.0%) at 70 years of age, rising to 5.6% (95% CrI, 3.9% –7.7%) at age 80 and 20% (95% CrI, 14% –27%) at age 90.

In conclusion, studies using recognized classifications systems with fundus photography reported the lowest prevalences of AMD taking account of age and gender, and were stable over time, with a potentially higher risk of NVAMD for women. These prevalence estimates can be used to guide health service provision in populations of European ancestry.

SOURCE: Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta-analysis. Ophthalmol. 2012;119(3):571–580.










 




  • GLAUCOMA CANDIDATE BOL 303259 X MEETS PRIMARY ENDPOINT IN PHASE 2b STUDY. Bausch + Lomb and NicOx S.A. have announced positive top-line results from the phase 2b study conducted with BOL 303259 X, a novel nitric oxide-donating prostaglandin F2 alpha analog, in patients with open-angle glaucoma or ocular hypertension. BOL 303259 X (previously NCX 116) was licensed by NicOx to Bausch + Lomb in March 2010. The phase 2b study met its primary efficacy endpoint and showed positive results on a number of secondary endpoints. The primary efficacy endpoint was the reduction in mean diurnal IOP on day 28. According to Bausch + Lomb, BOL 303259 X consistently lowered IOP in a dose-dependent manner and the most efficacious dose of BOL 303259 X also showed positive results on a number of secondary endpoints, including consistently better control of IOP over 24 hours on day 28. To read more about the Phase 2b study, visit www.bausch.com.
  • OMEROS'S OMS302 ACHIEVES PRIMARY AND SECONDARY ENDPOINTS IN PHASE 3 CLINICAL TRIAL. In a recent press release, Omeros Corporation reported positive data from its Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros's proprietary PharmacoSurgery product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery. The product met its primary endpoint by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation). OMS302 also demonstrated statistical superiority (p<0.00001) over placebo in reduction of pain in the early postoperative period.
  • LENSAR SECURES PRIVATE FINANCING TO SUPPORT COMMERCIAL LAUNCH OF LASER SYSTEM. LensAR Inc. has announced the closing of a $24 million private financing, which included investments from Aisling Capital and Florida Growth Fund, and will support first commercial shipments of the LensAR Laser System in the United States, Europe and select markets worldwide. The financing will also support ongoing research and development activities for the LensAR Laser System in additional clinical applications. Click here to learn more.
  • VOLK TO LAUNCH NEW SURGICAL GONIO LENS. Volk Optical will be launching a new Surgical Gonio lens at this year's American Society of Cataract and Refractive Surgeons (ASCRS) Annual Meeting, April 20–24 in Chicago. According to the company, its Autoclavable Surgical Gonio Lens delivers clear direct views of the chamber angle structures for goniotomy and other surgical gonio procedures. Volk will be exhibiting its entire line of therapeutic, surgical and diagnostic ophthalmic lenses, including the new Surgical Gonio Lens, equipment, and accessories at booth 2207. Read more here.
  • NEW LED LIGHT SOURCE ENHANCES INTRA-OCULAR ILLUMINATION DURING VITREO-RETINAL SURGERY. Swiss company Oertli Instrumente AG recently introduced the new highly advanced Goodlight LED light source. According to the company, it enables excellent viewing and combines the advantages of healthy light with those of the latest LED technology. Goodlight LED is available with any Oertli OS3 (dual light source) and faros. Oertli says that compared with traditional light sources, light intensity is increased by up to 60%; and this without renouncing healthy light. Additionally, with Goodlight LED, the danger of photoretinitis is minimized without using additional filters. Learn more at www.oertli-instruments.com.
  • FDA CLEARS HEIDELBERG FOR SPECTRALIS ANTERIOR SEGMENT MODULE. The FDA has granted Heidelberg Engineering GmbH clearance for the new, Spectralis Anterior Segment Module (ASM), which provides high-resolution images of cornea, anterior chamber angle and sclera utilizing unique Heidelberg Noise Reduction technology for enhanced detail. Heidelberg says that with the ASM, clinicians can assess both chamber angles at the same time using a 16-mm-wide angle-to-angle OCT scan. Visit the company's website to read more.
  • ALCON GAINS EXCLUSIVE RIGHTS TO COMMERCIALIZE OCRIPLASMIN FOR TREATMENT OF VMA OUTSIDE U.S. In a recent press release, Alcon announced that it has gained exclusive rights to commercialize ocriplasmin outside the United States in more than 40 countries worldwide for the treatment of symptomatic vitreomacular adhesion (VMA). Ocriplasmin is a recombinant truncated form of human protein (plasmin) administered through a one-time intravitreal injection and is currently under review with the European Medicines Agency as the first pharmacological treatment for VMA, including macular hole. Under the terms of an agreement with ThromboGenics, Alcon will make an upfront payment of approximately $100 million to ThromboGenics, with additional potential payments based on milestones, as well as royalties on sales of ocriplasmin, if approved. ThromboGenics retains the rights to commercialize ocriplasmin in the United States and will have a strategic and focused operational role in the commercialization of ocriplasmin in the five largest European markets. The agreement also specifies that Alcon and ThromboGenics will work together, and share the costs, to further develop new clinical applications of the product that the companies will introduce in their respective territories. A decision on approval is expected from the FDA in the second half of 2012.
  • LPATH TO CONTINUE iSONEP TRIALS IN AUGUST. Lpath, Inc. plans to manufacture new antibody drug substance in preparation for the continuation of its PEDigree and Nexus trials, which are testing iSONEP as a treatment for wet AMD (Nexus) and pigmented epithelial detachment (PEDigree). The company plans to submit the necessary documentation regarding the new drug material to the FDA by June and expects both trial will be open for enrollment in August. Visit www.lpath.com.
  • DIGITAL IMAGING SYSTEM PROGRAM FOR INFANTS IMPLEMENTED IN RUSSIAN FEDERATION. Clarity Medical Systems, Inc. recently reported that it has implemented a significant RetCam digital imaging system program in the Russian Federation. Russian President Dmitry Medvedev approved the initial purchase of RetCam Systems for 42 of the country's 83 states to be used in care centers handling prematurely born infants at risk for eye diseases such as retinopathy of prematurity.
  • pSIVIDA AND NEURON SYSTEMS TO COLLABORATE ON DURASERT TECHNOLOGY. pSivida Corp. has entered into a technology evaluation agreement for its bioerodible Durasert drug delivery technology in ophthalmology with Neuron Systems, Inc. Under the terms of the agreement, the companies will evaluate the use of pSivida's technology as a delivery system for a treatment for dry AMD.
  • FIRST INSIGHT AWARDED FOR COMMITMENT TO ELIMINATING ELECTRONIC RX ERRORS. Surescripts has awarded First Insight Corporation, developers of MaximEyes practice management and ONC-ATCB certified HER, the 2011 White Coat of Quality award for its commitment to eliminating electronic prescription content errors. The White Coat recognizes organizations that uphold the highest standards of quality in e-prescribing.




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