Review of Ophthalmology® > Review of Ophthalmology Online > July 23, 2012

Volume 12, Number 30

Monday, July 23, 2012

JULY IS EYE INJURY PREVENTION MONTH

In this issue: (click heading to view article)

		From the Editor: Hope and Change

		Outer Retinal Layer Morphology and Visual Acuity in Patients with RVO

		Prediction of the Development of OAG Using Baseline Risk Factors

		Compatibility of Recombinant Tissue Plasminogen Activator and Bevacizumab Co-Applied for Neovascular AMD with Submacular Hemorrhage

		CCT and IOP in Children Undergoing Congenital Cataract Surgery

		Briefly

From the Editor: Hope and Change

Well, it seems that Supreme Care has give the Accountable Care Act (ACA) their “seal of approval” in a way. Looks like it's full steam ahead from here. My career has spanned many decades, and I have seen many events come down the road that I feared would change the landscape of medicine in a significant way. In the long run, though, they had far less impact on the way I practiced medicine than I originally envisioned. Early on, there were DRGs, then Medicare reimbursement reductions, risk sharing, capitated contracts, HIPAA, etc. I fear that the ACA will be the game-changer.

I would be the first to defend the art and quality of medical care in the United States, and in the same breath, I fully respect my international colleagues as well. Over the years, I have had the privilege to travel and visit with colleagues in Canada, Italy, Greece, India, and Turkey. The interactions were one of the high points in my career, but I also really appreciate all I have at my disposal in the United States to provide care to my patients.

Let's face it—patients have it really good here whether they are willing to acknowledge it or not. How will that change under the ACA? I do not think we will know for years to come. I do know that in its present form, this will be the thing that transforms medical care going forward in this country. No doubt, all citizens need good and easy access to care that is affordable. Every physician would acknowledge that. That is our hope. The ACA fails to embrace free market solutions, which could help mitigate cost and quite mysteriously, it bypassed tort reform all together. Imagine that!

In closing, I want to tell you a story about an interaction I had with a patient the other day. He was in for a follow-up exam post cataract surgery, and as he was leaving, he commented to me that he was very happy his cataracts had matured and that he had his surgery now. I questioned why, and he told me that many of his friends were so fearful of not being able to receive the necessary surgery they would need under the ACA. As he put to me, “All of my friends are getting their eye and joint surgery done now before they can't.” I felt bad for his friends and their fear of change.

Stephen Pascucci, MD, FACS

Outer Retinal Layer Morphology and Visual Acuity in Patients with RVO

To assess associations between visual acuity (VA) and the status of the photoreceptor inner segment-outer segment (IS-OS) junction in a subset of patients in the Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study, researchers evaluated high-resolution time domain optical coherence tomography (OCT) scans of study eyes from a single site participating in the SCORE Study.

They also evaluated the integrity of the IS-OS junction in the central subfield using a three-step scale: absent, abnormal or normal and investigated associations of the IS-OS status with ETDRS VA letter score and center point thickness (CPT).

The study researchers evaluated baseline OCTs of 42 eyes and noted that the IS-OS junction was absent in 30 (71%) and abnormal in 12 (29%). They also found that at month 12, the IS-OS junction was absent in 18 (43%), abnormal in 12 (28%), and normal in 12 (28%) eyes. At baseline, they reported that IS-OS status was significantly associated with CPT, but not with VA and that at month 12, IS-OS status was significantly associated with CPT and VA, that is, absent or abnormal IS-OS was associated with increased CPT and worse VA. Change in IS-OS status was not associated with change in CPT (p=0.8), worsening of IS-OS status was associated with loss of VA and improvement in IS-OS status to normal was associated with gain in VA (p=0.03).

In this data set with long-term follow-up of OCTs as part of the SCORE Study, there is a correlation between changes in IS-OS status and VA, which supports further evaluation of outer retinal morphology in larger data sets.

SOURCE: Domalpally A, Peng Q, Danis R, et al; the SCORE Study Research Group. Association of outer retinal layer morphology with visual acuity in patients with retinal vein occlusion: SCORE Study Report 13. Eye. 2012;26(7):919–924.

Prediction of the Development of OAG Using Baseline Risk Factors

The following population-based, prospective cohort study aimed to determine which baseline sociodemographic, lifestyle, anthropometric, clinical, and ocular risk factors predict the development of open-angle glaucoma (OAG) in an adult population.

A total of 3,772 self-identified Latinos aged ≥40 years from Los Angeles who were free of OAG at baseline were included. Participants from the Los Angeles Latino Eye Study had standardized study visits at baseline and 4-year follow-up with structured interviews and a comprehensive ophthalmologic exam. OAG was defined as the presence of an open angle and a glaucomatous visual field abnormality and/or evidence of glaucomatous optic nerve damage in ≥1 eye. Additionally, multivariate logistic regression with stepwise selection was performed to determine which potential baseline risk factors independently predict the development of OAG. Main outcome measures were odds ratios for various risk factors.

Over the 4-year follow-up, 87 participants developed OAG. The baseline risk factors that predict the development of OAG include older age (odds ratio [OR] per decade, 2.19; 95% confidence interval [CI], 1.74–2.75; p<0.001), higher intraocular pressure (IOP; OR per mmHg, 1.18; 95% CI, 1.10–1.26; p<0.001), longer axial length (OR per mm, 1.48; 95% CI, 1.22–1.80; p<0.001), thinner central cornea (OR per 40 µm thinner, 1.30; 95% CI, 1.00–1.70; p=0.050), higher waist-to-hip ratio (OR per 0.05 higher, 1.21; 95% CI, 1.05–1.39; p=0.007) and lack of vision insurance (OR, 2.08; 95% CI, 1.26–3.41; p=0.004).

To conclude, despite a mean baseline IOP of 14 mmHg in Latinos, higher IOP is an important risk factor for developing OAG. Biometric measures suggestive of less structural support such as longer axial length and thin central corneal thickness were identified as important risk factors. Lack of health insurance reduces access to eye care and increases the burden of OAG by reducing the likelihood of early detection and treatment of OAG.

SOURCE: Jiang X, Varma R, Wu S, et al; Los Angeles Latino Eye Study Group. Baseline risk factors that predict the development of open-angle glaucoma in a population: The Los Angeles Latino Eye Study. Ophthalmology. 2012;Jul 16.[Epub ahead of print].

Compatibility of Recombinant Tissue Plasminogen Activator and Bevacizumab Co-Applied for Neovascular AMD with Submacular Hemorrhage

The authors of this German study investigated the compatibility of recombinant tissue plasminogen activator (rtPA) and bevacizumab in vitro because during surgery, rtPA or rtPA-induced plasmin may cleave and inactivate bevacizumab.

To simulate the intraoperative range of mixing ratios of rtPA, bevacizumab, and subretinal blood, they calculated the volumes of 12 submacular hemorrhages (SHs) with a spherical cap formula using measurements derived from fundus photographs and spectral-domain optical coherence tomographic images. The authors incubated bevacizumab with rtPA or plasmin before gel electrophoresis with Coomassie blue and silver staining and quantified the anti-angiogenetic activity of bevacizumab in the presence of rtPA with or without clotted human blood or of plasmin by vascular endothelial growth factor (VEGF)-enzyme-linked immunosorbent assay after incubation with the supernatant of porcine retinal pigment epithelium cell cultures.

According to the study authors, the mean (SD) volume of SH was 28.6 (24.7) mm³ (range, 6.2–94.6 mm³) and in sodium dodecyl sulfate-polyacrylamid electrophoresis with Coomassie blue or silver staining, bevacizumab displayed characteristic patterns of protein bands. The detected no additional fragments in co-application of bevacizumab with either rtPA or plasmin. Moreover, the anti-angiogenetic activity of bevacizumab remained unchanged in co-application with rtPA with or without blood or plasmin.

The authors demonstrated the absence of cleavage or functional inactivation of bevacizumab by rtPA in an in-vitro model of their intraoperative co-application as a treatment of SH.

SOURCE: Klettner A, Puls S, Treumer F, et al. Compatibility of recombinant tissue plasminogen activator and bevacizumab co-applied for neovascular age-related macular degeneration with submacular hemorrhage. Arch Ophthalmol. 2012;130(7):875–881.

CCT and IOP in Children Undergoing Congenital Cataract Surgery

Investigators in Brazil examined changes in central corneal thickness (CCT) and intraocular pressure (IOP) in children after congenital cataract surgery, as well as risk factors associated with these changes.

They prospectively recruited 37 eyes of 26 children with congenital cataract undergoing surgery and performed IOP and CCT measurements before the surgery and 6, 12, 18, 24, and 36 months after the procedure.

The investigators reported that among the 37 eyes, 15 became aphakic and 22 pseudophakic. They noted that mean CCT significantly increased from 556.24 ± 44.19 to 585.07 ± 56.45 µm (p=0.003) after 3 years, whereas mean IOP significantly increased from 12.05 ± 2.3 to 13.89 ± 2.96 mmHg (p=0.037). Aphakic eyes underwent surgery at an early age (15.16 ± 32.02 months) compared with pseudophakic eyes (71.48 ± 53.14 months) (p<0.001). After 3 years, mean CCT change in aphakic eyes (56.10 ± 46.97 µm) was significantly higher than in pseudophakic eyes (12.71 ± 38.41 µm) (p=0.015), the investigators found. They also observed that age at the time of surgery was inversely correlated to CCT change (r=–0.34, p=0.04), but not to IOP change (r=–0.18, p=0.27). When surgery was performed between 0 and 1 year of age, mean CCT change at 3 years was 70.11 ± 42.3 µm, compared with 6.27 ± 28.09, –17.0 ± 8.04 and 48.33 ± 34.99 µm when surgeries were performed at 1–5, 5–10, and >10 years old, respectively (p<0.001). IOP change was not correlated to CCT change (r=0.31, p=0.06).

In conclusion, CCT increased in eyes undergoing congenital cataract surgery, especially when the surgery is performed at an early age.

SOURCE: Resende GM, Lupinacci AP, Arieta CE, Costa V. Central corneal thickness and intraocular pressure in children undergoing congenital cataract surgery: a prospective, longitudinal study. Br J Ophthlamol. 2012; Jul 19. [Epub ahead of print].

FDA CLEARS PSIVIDA CORP. FOR PIVOTAL TRIALS TO TREAT UVEITIS. pSivida Corp. recently announced that the FDA has cleared its Investigational New Drug (IND) application to treat posterior uveitis with the company's injectable sustained-release micro-insert. Now, pSivida is permitted to move directly to two Phase 3 trials to treat patients with posterior uveitis. pSivida expects to enroll a total of 300 patients in these trials, which would be in addition to the recently announced investigator-sponsored trial studying the same device for posterior uveitis. For additional details, visit www.psivida.com.

ACUCELA AND OTSUKA PHARMACEUTICAL INITIATE PHASE 3 CLINICAL TRIAL FOR DRY EYE. Acucela Inc. and Otsuka Pharmaceutical Co., Ltd. have initiated a Phase 3 clinical trial to evaluate rebamipide ophthalmic suspension in patients with dry eye. The drug is a novel compound discovered by Otsuka Pharmaceutical and has a new mechanism of action to increase the level of mucin in the tear film covering the conjunctiva and cornea. It was launched in Japan in January 2012 for the treatment of dry eye syndrome as Mucosta ophthalmic suspension UD2%. The Phase 3 multienter, randomized, placebo-controlled, double-masked, clinical study will enroll an estimated 560 subjects and is expected to be completed by the end of 2013. Click here for more information.

ILUVIEN RECEIVES MARKETING AUTHORIZATION IN FRANCE FOR TREATMENT OF CHRONIC DME. According to Alimera Sciences, Inc., the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité due Médicament et des Produits de Santé) has granted marketing authorization to ILUVIEN, its sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide for up to 36 months, for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Read more at www.alimerasciences.com.

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