Volume 14, Number 31
Monday, August 4, 2014


In this issue: (click heading to view article)
######### From the Editor: Reconnecting in Real Time
######### Vision-Related Quality of Life Among Patients With Cataracts and the Outcomes of Cataract Surgery
######### Serum Cytokines as Biomarkers for AMD
######### Visual Outcome of PDT + Intravitreal Bevacizumab With or Without Subtenon Triamcinolone Acetonide Injections for PCV After Three Years
######### Outer Retinal Tabulation


From the Editor: Reconnecting in Real Time

Okay, I know this editorial has nothing to do with ophthalmology, but I think that sometimes we all need to take a break from our chosen profession to reflect on life, which too often gets ignored.

My wife and I are in love with Italy. We try to visit for a few weeks every summer. Italy is therapy for us; nowhere else can compare. One of our favorite places is Capri. Although quite busy this year for my taste, it remains a magical island. For those who have never been, the main town is called Capri town. It is essentially totally pedestrian, except for the occasional electric cart that shuttles luggage and supplies about. So you end up walking a lot, which, in part, helps balance out the pasta consumption. This year, on numerous occasions, I walked by a little park. During the day, it served for moms to meet and chat while their children played. One night, though, as we walked by on our way to dinner, I noticed that a generous number of chairs were set up for what was to be an outdoor concert. About 100 people of all ages stood about chatting while children played. What I also noticed was that not one individual was on a cell phone—not talking, texting or checking email. Just a gathering of individuals talking directly to one another.

As I thought about it further, it made me sad in a way. It was a joy to see humans communicating face to face with one another, which is actually quite common in that part of the world. It seems that we have lost touch with on another. A text now replaces a conversation. Yes, quite efficient, but not very personal. I feel we have become individuals who are more outraged by Twitter or Facebook going down than by an airplane being shot down with innocent lives on board. Time away from the office allows us to think, and analyze our lives. Don't undervalue the importance of making time for loved ones, for yourself, and for that therapy.



Vision-Related Quality of Life Among Patients With Cataracts and the Outcomes of Cataract Surgery

In the study below, the authors investigated vision-related quality of life (VRQoL) and associated factors in patients with cataracts and the outcomes of cataract surgery using the newly developed VRQoL instrument: the visual function questionnaire, 11-item Japanese version (the VFQ-J11).

Included in the study were 457 patients scheduled for cataract surgery at 12 clinical sites from November 2008 through February 2010. The patients completed the VFQ-J11 before and three months after surgery and the authors used the VFQ-J11 to investigate factors associated with VRQoL of the cataract patients, the outcome of cataract surgery and the predictors of improved VRQoL due to cataract surgery.

They found that in a multiple regression model, the VFQ-J11 score was significantly associated with corrected distance visual acuity in the better-seeing eye (better eye VA), and improvement in the VFQ-J11 score after cataract surgery was associated not only with improvement in the better eye VA, but also with improvement in the worse eye VA. Compared to one-eye cataract surgery, both-eyes surgery had a greater impact on VFQ-J11 score improvement.

The study authors concluded that VFQ-J11 is a good measure of VRQoL in cataract patients. The present study indicates that by including the domains measured in the VFQ, the VFQ-J11 can provide valid data on VRQoL and be less of a burden for patients.

SOURCE: Hiratsuka Y, Yamada M, Akune Y, et al. Assessment of vision-related quality of life among patients with cataracts and the outcomes of cataract surgery using a newly developed visual function questionnaire: the VFQ-J11. Jpn J Ophthalmol. 2014; Jul 19. [Epub ahead of print].

Serum Cytokines as Biomarkers for AMD

To evaluate the potential of serum pro-inflammatory cytokines as age-related macular degeneration biomarkers, researchers examined serum samples from 30 AMD patients and 15 age-matched controls for 16 inflammatory cytokines using multiplex ELISA. Using optical coherence tomography and funduscopy, they divided patients into three subgroups: improvement; no change; and deterioration during anti-vascular endothelial growth factor treatment and correlated them to the cytokine levels.

According to the researchers, serum concentrations of IL-1α, IL-1β, IL-4, IL-5, IL-10, IL-13 and IL-17 were significantly higher in AMD patients than in controls. They found that none of the co-variables expressed a significant effect on the tested cytokines and that only IL-1a and IL-17 showed a statistically significant difference between groups (improved, unchanged, deteriorated) as determined by one-way ANOVA. Patients with increased macular thickness during treatment showed significantly lower levels of IL-17 compared to improved cases and to unchanged cases (p=0.004, 0.03 respectively, Dunnett's T3 post hoc multiple test). TNF-α was significantly higher in improved cases compared to deteriorated cases (p=0.03, Dunnett's T3 post hoc multiple test). Moreover, the researchers noted that IL-17 was a significant predictor for macular edema using linear regression (β=−0.888, p<0.05).

They determined that elevation of IL-1α, IL-1β, IL-4, IL-5, IL-10, IL-13 and IL-17 in the serum of AMD patients supports the hypothesis of AMD as an inflammatory disease. Patients with high IL-17 and TNF-α serum levels were more likely to have a favorable course under VEGF therapy. These cytokines may be used as easy-to-obtain biomarkers.

SOURCE: Nassar K, Grisanti S, Elfar E, et al. Serum cytokines as biomarkers for age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2014;Graefes Arch Clin Exp Ophthalmol. 2014;Jul 24. [Epub ahead of print].


Visual Outcome of PDT + Intravitreal Bevacizumab With or Without Subtenon Triamcinolone Acetonide Injections for PCV After Three Years

In this Japanese retrospective, comparative, interventional case series, investigators compared the three-year visual outcome after double therapy of photodynamic therapy with intravitreal bevacizumab and triple therapy of PDT combined with intravitreal bevacizumab and subtenon triamcinolone acetonide (STTA) injections for polypoidal choroidal vasculopathy.

They retrospectively reviewed the medical records for 36 eyes in 36 patients (33 men, three women; mean age 73.5 years old; range 63 to 82 years old) with treatment-naïve subfoveal PCV. Of the 36 eyes, they treated 17 with double therapy and 19 with triple therapy.

The change in visual acuity following triple therapy was significantly better than that after double therapy (p<0.05), the investigators reported. At 36 months, they noted improvement in visual acuity in five eyes (29.4%) in the double-therapy group and 10 eyes (52.6%) in the triple-therapy group. They performed retreatment using the initial treatment for six eyes (35.3%) in the double-therapy group and five eyes (26.3%) in the triple-therapy group; the treatment-free period was significantly longer in the triple-therapy group (p<0.05). Additionally, the mean number of additional anti-vascular endothelial growth factor therapy was higher in the double-therapy group. Post-treatment vitreous hemorrhage or retinal pigment epithelium tear occurred only in the double-therapy group, in one eye (5.9%) and one eye (5.9%), respectively.

Initial therapy consisting of a single session of PDT combined with intravitreal bevacizumab and STTA improves vision in treatment-naïve subfoveal PCV. Compared with double therapy, this triple therapy may be more effective for PCV.

SOURCE: Sakai T, Ohkuma Y, Kohno H, et al. Three-year visual outcome of photodynamic therapy plus intravitreal bevacizumab with or without subtenon triamcinolone acetonide injections for polypoidal choroidal vasculopathy. Br J Ophthalmol. 2014;Jul 22. [Epub ahead of print].


Outer Retinal Tabulation

The purpose of this prospective cohort study within a randomized clinical trial was to determine the prevalence of, risk factors for, and visual acuity correlations with outer retinal tubulation (ORT) seen on spectral-domain optical coherence tomography in eyes with neovascular age-related macular degeneration after anti-vascular endothelial growth factor therapy.

Patients with SD-OCT images at weeks 56 and 104 in the Comparison of AMD Treatments Trials were assigned randomly to ranibizumab (0.5 mg) or bevacizumab (1.25 mg) treatment and to a monthly or pro re nata injection-dosing regimen. A subset of eyes was imaged with SD-OCT beginning at week 56. Cirrus 512×128 or Spectralis 20°×20° volume cube scan protocols were used to acquire SD-OCT images. Two independent readers at the CATT OCT reading center graded scans, and a senior reader arbitrated discrepant grades. The prevalence of ORT, identified as tubular structures seen on at least three consecutive Cirrus B scans or two consecutive Spectralis B scans, was determined. The associations of patient-specific and ocular features at baseline and follow-up with ORT were evaluated by univariate and multivariate analyses. Outer retinal tubulations were the main outcome measures.

It was noted that seven of 69 eyes (10.1%) at 56 weeks and 64 of 368 eyes (17.4%) at week 104 had ORTs. Absence of diabetes, poor VA, blocked fluorescence, geographic atrophy, greater lesion size and presence of subretinal hyper-reflective material at baseline was associated independently with greater risk of ORT at 104 weeks (p<0.05). Neither drug nor dosing regimen were associated significantly with ORT. Furthermore, the mean VA of eyes with ORT at week 104 (58.5 Early Treatment Diabetic Retinopathy Study letters) was worse than the mean VA of eyes without ORT (68.8 letters; p<0.0001).

To conclude, two years after initiation of anti-VEGF therapy for neovascular AMD, ORTs are present in a substantial proportion of eyes. This study identified baseline features that independently predict ORTs. It is important to identify ORTs because eyes with ORTs have worse VA outcomes than those without this finding.

SOURCE: Lee JY, Folgar FA, Maguire MG, et al.; for the CATT Research Group. Outer retinal tabulation in the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). Ophthalmology. 2014;Jul 23. [Epub ahead of print].


  • PHASE II CLINICAL TRIAL INITIATED TO EVALUATE LE-MPP IN RVO, DME AND MGD. Kala Pharmaceuticals Inc. has initiated a Phase II clinical trial (KPI-121-C-004) to evaluate its loteprednol etabonate Mucus Penetrating Particle (LE-MPP) drug product, KP-121, in patients with intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema. The single-masked, randomized trial will investigate the efficacy and safety of 1% LE-MPP and 0.25% LE-MPP dosed q.i.d. in patients having measurable intraretinal or subretinal fluid secondary to RVO or DME. Kala aims to enroll up to 20 patients at two U.S. centers. The company has also initiated a Phase II clinical trial (KPI-121-C-003) of LE-MPP, in which it will study the safety and efficacy of 0.25% LE-MPP compared to vehicle dosed q.i.d. in subjects with meibomian gland disease. Kala aims to enroll roughly 150 patients in up to 10 U.S. centers in this double-masked, randomized trial. Find out more by visiting www.kalarx.com.

  • EYLEA NOW FDA-APPROVED FOR TREATMENT OF DME. The FDA has approved Regeneron Pharmaceuticals Inc.'s EYLEA (aflibercept) Injection for the treatment of diabetic macular edema. The recommended dosage of EYLEA in patients with DME is 2 mg every two months following five initial monthly injections. According to Regeneron, the approval of EYLEA in DME was based on the one-year data from the Phase III VISTA-DME and VIVID-DME studies of 862 patients that compared EYLEA 2 mg given monthly, EYLEA 2 mg given every two months (following initial monthly injections) or macular laser photocoagulation (at baseline and then as needed). Read more about DME, EYLEA and the two trials here.

  • US OPTHALMICS UNVEILS NEW ALL-IN-ONE DIGITAL REFRACTION SYSTEM. US Ophthalmics' Ezer Digital Practice 7800 is an all-inclusive refraction system that optimizes the refracting process to increase efficiency while getting superior results, says the company. The Ezer Digital Practice 7800 is comprised of three devices: the ERK-7800 Autorefractor/Keratometer, the EDR-7800 digital refractor and the ECP-5400 chart projector. The ERK-7800 combines all of the necessary visual pre-testing functions in one smartly designed instrument and operators can perform refractometry and keratometry alone or simultaneously. Additionally, the recently re-engineered EDR-7800 digital refractor allows users to completely program their preferences into it to reliably perform the refraction steps in a specific order. And finally, the high-resolution ECP-5400 chart project is compact and lightweight and features a highly versatile, programmable remote control. Visit US Ophthalmics' website to learn more.

  • FCI OPHTHALMICS INTRODUCES NEW AND IMPROVED SELF-RETAINING BICANALICULUS STENT SET. Recently, FCI Ophthalmics unveiled a New & Improved Self-Retaining Bicanaliculus Intubation Set designed by Pierre Bigé, MD. Nicknamed the SRSII, the stent allows physicians to intubate the upper and lower canaliculi in the office with just topical anesthetic drops and without having to enter through the nasal passageway. Made of medical grade silicone, the 0.64-mm wide tube is available in lengths of 25 mm, 30 mm and 35 mm. FCI Ophthalmics explains that each end of the tube has an anchor-shaped head with two flexible winglets that fold inward during insertion through the punctum and that insertion is simplified with pre-loaded introducers on each end. Primary indications for the SRSII include horizontal lacrimal duct stricture or punctual stenosis.

  • SIMBRINZA CLEARED TO TREAT PATIENTS LIVING WITH GLAUCOMA IN THE EU. Simbrinza eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension for which monotherapy provides insufficient IOP reduction. Simbrinza, which was approved by the FDA in 2013, is the only fixed-combination glaucoma treatment that does not contain a beta-blocker. The launch of Simbrinza in the EU will begin in the United Kingdom in the third quarter of 2014, followed by other European markets later in 2014 and in 2015. Click here for additional details.

  • ILUVIEN RECEIVES MARKETING AUTHORIZATION IN NORWAY AND DENMARK FOR THE TREATMENT OF CHRONIC DME. Alimera Sciences Inc. announced this past week that the Norwegian Medicines Evaluation Board and the Danish Health and Medicines Authority have granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Norway is the first country (and Denmark the second) to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application. The sustained-release intravitreal implant is now also approved for marketing in Austria, France, Germany, Italy, Portugal, Spain and the United Kingdom, and is commercially available in the United Kingdom and Germany.

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