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Volume 13, Number 12
Monday, March 25, 2013
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MARCH IS NATIONAL NUTRITION MONTH




In this issue: (click heading to view article)
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######### Effect of Lutein Supplementation on VA Over a One-year Period in Early AMD

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######### Association Between Change in CCT and VF Progression in Glaucoma
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######### Connection Between Retinal Sensitivity and Integrity of Photoreceptor IS/OS Junction in Patients With DME
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######### Factors Linked to Progression of VF Loss in NTG Patients With Medical Treatment
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Effect of Lutein Supplementation on VA Over a One-year Period in Early AMD

Investigators conducted a randomized, double-blind, placebo-controlled, two-center investigation to examine the effect of daily supplementation with lutein capsules on macular pigment optical density (MPOD) and visual acuity (VA) in patients with early age-related macular degeneration (AMD).

The trial took place at centers in Manchester, the United Kingdom and Maastricht, as well as the Netherlands, and lasted 12 months. The investigators randomly assigned 72 patients (mean age 70.5 ± 8.7) to either lutein capsules (10 mg Ester, n=36) or placebo (n=36) groups. Patients took lutein capsules or placebo daily. MPOD using a flicker-based technique (MPS9000) and best-corrected VA (LogMAR) were measured by investigators at the beginning and at four-month intervals over the duration of the supplementation period. Blood serum samples were collected to monitor compliance.

At the end of the trial, the study investigators observed an overall increase in the mean MPOD level for the lutein group from 0.38 ± 0.19 to 0.53 ± 0.22 optical density (OD) units. According to a mixed design ANOVA, this was statistically significant (p<0.001). No change in MPOD was found for the placebo group and there was no significant change in VA in the lutein group (n=36). The investigators noted that the placebo group (n=36) showed a statistically significant deterioration from 0.05 ± 0.13 to 0.09 ± 0.13 (p<0.05). When comparing the change in VA over the supplementation period, they found a significant difference between the two groups (p<0.05). To avoid ceiling effects, they reanalyzed two subgroups of patients with VA worse than 0.06 at baseline. In the lutein subgroup (n=19), they observed a mean improvement in VA from 0.23 ± 0.12 at baseline to 0.16 ± 0.10 at visit four (p<0.05). They also reported a small deterioration in the placebo subgroup (n=14) from 0.18 ± 0.13 to 0.19 ± 0.12 (p=0.70). They also compared the improvement in VA in the lutein subgroup to the deterioration in VA in the placebo group and this effect reached statistical significance (p<0.05).

Lutein supplementation increases MPOD levels in early stage AMD patients. According to the VA measurements, the progress of the disease might be slowed in some patients with augmented levels of MP.

SOURCE: Murray IJ, Makridaki M, van der Veen RL, et al. Lutein supplementation over a one-year period in early AMD might have a mild beneficial effect on visual acuity: the CLEAR study. Invest Ophthalmol Vis Sci. 2013;54(3):1781–1788.



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Association Between Change in CCT and VF Progression in Glaucoma

To assess the relationship between baseline central corneal thickness (CCT) and/or ongoing CCT change over time with subsequent visual field progression, 163 eyes of 163 patients with medically treated glaucoma were followed up for 6.8 ± 1.8 years.

Exclusion criteria was laser or intraocular surgery. Baseline and follow up CCT, confocal scanning laser tomography and visual fields were performed. CCT and CCT change related to visual field progression using Glaucoma Progress Analysis were also assessed and multivariate logistic regression analysis for predictive factors of glaucoma progression was used to analyze data.

Thinner baseline CCT was associated with more advanced damage at presentation, mean deviation (MD) (r=0.17, p=0.02) and neuroretinal rim area (NRR) (r=0.20, p=0.02). It was noted that progressing eyes had significantly thinner (p=0.01) baseline CCT compared to non-progressing eyes and that the slope of visual field change was significantly greater (p=0.05) for thinner (<540 µm) as compared to thicker eyes. A small but significant CCT reduction (12.78 ± 13.35 µm, p<0.0001) was noted in all eyes; however, there was no significant difference (p=0.95) in the amount of change between progressing and non-progressing eyes. CCT change did not correlate with MD or NRR change. Moreover, a thinner CCT (Odds ratio=1.80, p=0.02), but not CCT change (Odds ratio=1.07, p=0.69), was a significant risk factor for glaucoma progression.

In conclusion, CCT correlates significantly with the amount of glaucomatous damage at presentation. Thinner corneas may be associated with increased risk of visual field progression. CCT reduced slightly over time in eyes with glaucoma; but the magnitude of this change was not related to visual field progression.

SOURCE: Viswanathan D, Goldberg I, Graham SL. Relationship of change in central corneal thickness to visual field progression in eyes with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2013; March [Epub ahead of print].






Connection Between Retinal Sensitivity and Integrity of Photoreceptor IS/OS Junction in Patients With DME

In the following cross-sectional study, researchers included 25 adult patients (37 eyes) diagnosed with diabetic macular edema (DME) and managed at the Wilmer Eye Institute, Johns Hopkins University, to evaluate the relationship between retinal sensitivity and the photoreceptor inner segment/outer segment (IS/OS) layer status in patients with DME.

They obtained simultaneous fundus microperimetry (MP) and optical coherence tomography (OCT) of patients with DME using a combined MP/OCT system. The device recorded retinal sensitivity and retinal thickness on a three-dimensional tomography map, and the researchers performed a point-by-point analysis of the IS/OS layer integrity at every MP point. They also reviewed OCT scans to determine the type of DME, cystoid macular edema (CME) or diffuse macular edema (absence of any cysts). In addition, they analyzed fixation stability and location. Retinal point sensitivity measured by MP was the main outcome measure.

The study researchers enrolled 25 patients (37 eyes: 29 male and eight female; mean age, 64.16 years) with DME. They observed that fixation was centric in 30 eyes (81%), paracentric in three eyes (8%), and eccentric in four eyes (11%). They noted that 27 eyes had CME and 10 eyes had diffuse macular edema. Mean central subfield thickness was 325 µm. The researchers analyzed a total of 1,036 individual MP points. They reported that mean point sensitivity was 10.51 dB. A total of 793 points (76.5%) had IS/OS layer present, and 243 points (23.5%) had IS/OS layer disrupted. A mixed linear model, constructed to adjust for potential confounders and account for dependence between retinal points, revealed that the absence of the IS/OS junction was significantly associated with a 3.28-dB decrease in retinal point sensitivity (p<0.001).

This novel index study demonstrates that disruption of the IS/OS junction is correlated with a significant decrease in point sensitivity in eyes with DME. Further studies are indicated to confirm and validate this relationship.

SOURCE: Yohannan J, Bittencourt M, Sepah YS, et al. Association of retinal sensitivity to integrity of photoreceptor inner/outer segment junction in patients with diabetic macular edema. Ophthalmology. 2013;Mar 15. [Epub ahead of print].






Factors Linked to Progression of VF Loss in NTG Patients With Medical Treatment

The authors of the following study investigated the prognostic factors responsible for the progression of visual field defects (VFDs) in patients with normal-tension glaucoma (NTG) treated with topical anti-glaucoma medications. They found the extent of myopia to be a significant positive prognostic factor for VFD progression in the upper paracentral subfield for non-high-myopic NTG eyes with an average IOP of 14.2 mmHg under topical anti-glaucoma medication.

They retrospectively analyzed 92 eyes in 92 NTG patients treated with only topical anti-glaucoma medications for ≥5 years. To identify subfield-based prognostic factors, the authors divided the central 30-degree visual field (Humphrey Field Analyzer) into six subfields: upper and lower arcuate, paracentral and cecocentral subfields. They also evaluated factors related to subfield-based progression (age, refraction, mean intraocular pressure [IOP], IOP variability, central corneal thickness and disc hemorrhage) using a linear mixed model.

According to the authors, the mean observation period was 7.7 ± 2.7 (5.0 to 15.5) years, and the estimated rate of change in the mean deviation value was –0.16 ± 0.31 dB/y (p<0.001). They reported that a subfield-based linear mixed model analysis of the time course of changes in the mean of total deviation identified a greater extent of myopia as a significant positive prognostic factor for VFD progression in the upper paracentral area (p=0.016). Furthermore, the mean IOP, central corneal thickness, disc hemorrhage, age, and IOP variation showed no significant contribution in any of the subfields.

To conclude, the extent of myopia was found to be a significant positive prognostic factor for VFD progression in the upper paracentral subfield for non–high-myopic NTG eyes with an average IOP of 14.2 mmHg under topical anti-glaucoma medication.

SOURCE: Sakata R, Aihara M, Murata H, et al. Contributing factors for progression of visual field loss in normal-tension glaucoma patients with medical treatment. J Glaucoma. 2013;22(3):250–254.




  • AVASTIN SYRINGES, AMONG OTHER PRODUCTS, RECALLED BY COMPOUNDER. Compounding pharmacy Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. In a news release, the company explained that the recall of all sterile products is conducted in follow-up to concerns regarding practices at the site that cannot assure the sterility of the products. The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. There has been no evidence of contamination with sterile products other than the specified Avastin lots, however, Clinical Specialties has decided, in the interest of its patients, to proceed with this recall process. The Centers for Disease Control and Prevention notified the FDA of these endophthalmitis infections. Clinical Specialties Compounding repackaged the Avastin into individual single-use syringes from the manufactured vials labeled as sterile. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013. Until further notice, health-care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Those with questions about this recall are urged to call (866) 880-1915 or email clinicalrx@bellsouth.net. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
  • FDA GIVES MARKET CLEARANCE TO VITRA MULTISPOT LASER. French company Quantel Medical has received 510(k) market clearance from the FDA for the Vitra Multispot laser, which was developed to give access to advanced pattern-scanning technology to ophthalmology practices worldwide through intelligent design. The laser combines advanced pattern scanning and solid-state green laser technologies in a compact, portable platform. This design delivers a cost-effective solution to ophthalmologists around the world dealing with epidemic levels of diabetic eye disease in their patient populations. To learn more, click here.
  • PHASE III RESULTS POSITIVE FOR BROMSITE IN THE REDUCTION OF INFLAMMATION AND PAIN FOLLOWING CATARACT SURGERY. InSite Vision Inc. announced top-line results from its recently completed Phase III clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery. This is the first of two Phase III clinical studies in support of BromSite's regulatory submissions. The drug achieved statistically significant superiority compared to vehicle in alleviating ocular pain and inflammation among patients following cataract surgery. The Phase III clinical trial enrolled 268 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone BromSite was well tolerated, with no safety concerns or drug-related serious adverse events reported. Visit the company's website www.insitevision.com for more information.
  • ACUFOCUS SUBMITS PMA FOR APPROVAL OF FIRST CORNEAL INLAY FOR PRESBYOPIA. AcuFocus submitted the final module of its premarket approval application (PMA) for the KAMRA corneal inlay to the FDA. According to the company, the KAMRA corneal inlay is designed to revive reading vision by allowing only focused light to enter the eye. It has undergone rigorous approval processes in several countries and is now approved in 47 countries across Europe, Asia-Pacific, Middle East and the Americas, with the most recent approvals in Canada. Learn more at www.AcuFocus.com.
  • R-TECH UENO INITIATES PATIENT ENROLLMENT OF PHASE III CLINICAL STUDY WITH UNOPROSTONE OPHTHALMIC SOLUTION FOR TREATMENT OF RP. R-Tech Ueno has begun patient enrollment of a Phase III clinical study with Unoprostone (development code UF-021) ophthalmic solution for the treatment of retinitis pigmentosa (RP). The trial is a multicenter study using a placebo (without the active ingredient) as a control carried out based on Good Clinical Practice (GCP) in patients with visual field constriction and then deterioration of vision. It is a randomized, double-masked, controlled study for 52 weeks for efficacy, followed by the open trial study of UF-021 for a further 52 weeks for safety. R-Tech Ueno reports that the target sample size is 180 patients and that the study is being carried out at 38 sites nationwide. For additional information, visit http://rtechueno.com.
  • AVEDRO PREPARES FOR U.S. CLINICAL TRIAL OF HYPEROPIC LASIK XTRA. In preparation for its U.S. clinical trial, Avedro announced that a select group of U.S. refractive surgeons has recently completed Lasik Xtra procedure training under Gustavo Tamayo, MD, at the Bogota Laser Center in Bogota, Colombia. According to Avedro, Lasik Xtra is a two-minute procedure used in conjunction with standard LASIK to provide added strength and stability to the cornea during and after a LASIK procedure. Lasik Xtra combines riboflavin (vitamin B2) ophthalmic solution with Avedro's KXL System (UVA irradiation) to achieve accelerated corneal crosslinking during LASIK. The company's technology is currently being used in three Phase III clinical studies in the United States involving more than 100 clinical treatment sites.
  • CONSUMER EDUCATION ADVERTISING CAMPAIGN FEATURES TEARS AGAIN ADVANCED EYELID SPRAY. OCuSOFT Inc. has launched a new national consumer advertising campaign for Tears Again ADVANCED Eyelid Spray, available at various drug stores. The campaign aims to raise awareness of the role of eyelids in eye health, while providing a simple solution for dry, scratchy, irritated eyes, OCuSOFT says. Included in the multi-media campaign area a series of targeted broadcast commercials, promotional contests, coupons and digital online advertisements. Click here for additional information.



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