Volume 16, Number 49
Monday, December 5, 2016


In this issue: (click heading to view article)
######### Tracking Diplopia in Medically and Surgically Treated Glaucoma Cases
######### Correlation of Microvascular Structures on OCTA With VA in RVO
######### Optic Disc Hemorrhages in the Ocular Hypertension Treatment Study
######### Nondamaging Retinal Laser Therapy for Treatment of CSC


Tracking Diplopia in Medically and Surgically Treated Glaucoma Cases

Researchers reported on the prevalence, type and cause of diplopia in medically and surgically treated individuals with glaucoma, as part of a cohort study.

They prospectively enrolled 195 adult subjects with glaucoma who had undergone surgical or medical management. Forty-seven individuals had undergone glaucoma drainage device surgery (Baerveldt 350 & 250, Abbott Medical Optics; or Ahmed FP7, New World Medical), 61 had undergone trabeculectomy and 87 were medically treated. All completed the Diplopia Questionnaire to assess diplopia. Researchers defined the presence of diplopia as “sometimes,” “often” or “always” in distance straight ahead or reading positions. A strabismus specialist and a glaucoma subspecialist jointly performed chart reviews to characterize the type and cause of the diplopia. The main outcome measures were frequency, type and cause of diplopia.

Researchers reported diplopia in 41 of 195 medically and surgically treated individuals (21 percent) with glaucoma. Binocular diplopia due to the glaucoma procedure was present in 11 of 47 people (23 percent) after GDD (CI,12 to 38), which was significantly greater than in individuals after trabeculectomy (2/61 [3 percent]; 95 percent confidence interval, 0.4 to 11; p=0.002). The most common type of strabismus associated with binocular diplopia due to glaucoma surgery was hypertropia (10/11 GDD cases, 2/2 trabeculectomy cases). Researchers found monocular diplopia in a similar proportion of medically treated cases (4/87 [5 percent]), post-trabeculectomy cases (4/61 [7 percent)] and post-GDD cases (2/47 [4 percent]). They found binocular diplopia that was not the result of surgery to be in similar proportions as GDD cases (3/47 [6 percent]), trabeculectomy cases (5/61 [8 percent]) and medically treated cases and (10/87 [11 percent]).

Researchers concluded that diplopia may be underrecognized in medically and surgically treated cases with glaucoma, and standardization to ascertain individuals’ symptoms using the Diplopia Questionnaire may be useful. They determined that diplopia was more commonly seen after GDD than trabeculectomy, typically a noncomitant restrictive hypertropia, and that the prevalence of monocular diplopia and binocular diplopia unrelated to glaucoma surgery was similar among medical and surgical groups. Researchers suggested that clinicians should counsel individuals on the higher occurrence of diplopia associated with GDD surgery.

SOURCE: Sun PY, Leske DA, Holmes JM, et al. Diplopia in medically and surgically treated patients with glaucoma. Ophthalmology 2016; Nov. 18. [Epub ahead of print].

Correlation of Microvascular Structures on OCTA With VA in RVO

Scientists analyzed the correlation of superficial and deep capillary plexuses using optical coherence tomography angiography with visual acuity in eyes with retinal vein occlusion. They retrospectively reviewed the medical records of 33 individuals with RVO (branch RVO in 21 cases, central RVO in 11 cases) and included 33 healthy subjects as a control group, evaluated by OCTA.

OCTA was performed on a 3-mm x 3-mm region centered on the fovea and parafoveal area. The foveal avascular zone, and foveal and parafoveal vascular density in superficial and deep vascular plexuses were analyzed using OCTA.

The area of superficial and deep FAZ in eyes with RVO was larger than that in fellow eyes and control eyes (p=0.034, p=0.018). The number of superficial and deep parafoveal VDs in eyes with RVO was significantly lower than that in fellow eyes and control eyes (p=0.001, p<0.001). The area of superficial FAZ was negatively correlated with best-corrected visual acuity, and the superficial and deep parafoveal VDs were positively correlated with best-corrected visual acuity. Eighteen of 21 eyes with BRVO (85.7 percent) showed a high concordance rate with respect to the location of BRVO and the lowest parafoveal VD area. Multivariate analysis showed that the deep parafoveal VD was associated with BCVA.

Scientists suggested that OCTA enabled detection of FAZ enlargement, increased parafoveal capillary nonperfusion and decreased parafoveal VD in eyes with RVO. The area of superficial FAZ and parafoveal VD were correlated with BCVA in eyes with RVO, they added.

SOURCE: Kang J-W, Yoo R, Jo YH, et al. Correlation of microvascular structures on optical coherence tomography angiography with visual acuity in retinal vein occlusion. Retina 2016; Nov. 8. [Epub ahead of print].

Optic Disc Hemorrhages in the Ocular Hypertension Treatment Study

Investigators aimed to determine the cumulative incidence of optic disc hemorrhage before and after development of primary open-angle glaucoma; assess the prognostic significance of ODH for the development of POAG; and identify predictive factors for ODH, as part of a prospective cohort study.

They annually evaluated ODHs in 3,236 eyes of 1,618 Ocular Hypertension Treatment Study participants using stereoscopic optic disc photographs. They determined the incidence of ODH before and after the development of POAG, the risk of ODH for POAG and risk factors for ODH, using multivariate proportional hazards regression models.

After a median follow-up of 13 years, investigators detected one or more ODH in 179 eyes of 169 participants. The incidence of ODH was 0.5 percent per year during an average of 13 years before the development of POAG and 1.2 percent per year during an average of six years after the development of POAG. The cumulative incidence of POAG in eyes with ODH was 25.6 percent compared to 12.9 percent in eyes without ODH. The occurrence of an ODH increased the risk of developing POAG 2.6-fold in the multivariate analysis (CI, 1.7 to 4; p<0.0001). Randomization to the observation group, older age, thinner central corneal thickness, larger vertical cup-to-disc ratio, higher intraocular pressure and self-reported black race were identified as risk factors for ODH.

Investigators determined that ODH was an independent predictive factor for the development of POAG in individuals with ocular hypertension, and that predictive factors for ODH were similar to those for POAG in individuals with OHT.

Budenz DL, Huecker JB, Gedde SJ, et al. Thirteen-year follow-up of optic disc hemorrhages in the Ocular Hypertension Treatment Study. Am J Ophthalmol 2016; Nov 7. [Epub ahead of print].

Nondamaging Retinal Laser Therapy for Treatment of CSC

Researchers summarized the literature addressing subthreshold or nondamaging retinal laser therapy for central serous chorioretinopathy, and discussed results and trends that warrant further investigation by analysis of literature evaluating NRT with micropulse or continuous wave lasers for CSCR.

They included 16 studies of 398 subjects (e.g., retrospective case series, prospective nonrandomized interventional case series and prospective randomized clinical trials). All studies but one evaluated chronic CSCR, and laser parameters varied greatly between studies. Mean central macular thickness decreased on average by ~80 µm at three months. Mean best-corrected visual acuity increased on average by about nine letters at three months, and no study reported a decrease in acuity below presentation. No retinal complications were observed with the various forms of NRT used, but six subjects in two studies with micropulse laser experienced pigmentary changes in the retinal pigment epithelium attributed to excessive laser settings.

Researchers wrote that NRT demonstrated efficacy and safety in 12-month follow-up in subjects with chronic and possibly acute CSCR. They added that NRT would benefit from better standardization of the laser settings and understanding of mechanisms of action, as well as further prospective randomized clinical trials.

SOURCE: Wood EH, Karth PA, Sanislo SR, et al. Nondamaging retinal laser therapy for treatment of central serous chorioretinopathy: What is the evidence? Retina 2016; Nov. 10. [Epub ahead of print].



  • Allergan Receives FDA Clearance for Xen Gel Stent for Refractory Glaucoma
    Allergan announced the U.S. Food and Drug Administration cleared the Xen Glaucoma Treatment System (consisting of the Xen45 Gel Stent and the Xen Injector). The system reduces intraocular pressure in individuals and is indicated for the management of refractory glaucomas when previous surgical treatment has failed or in individuals with primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles unresponsive to maximum tolerated medical therapy. Xen is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. In the U.S. trial conducted in refractory glaucoma patients, Xen reduced IOP from a mean medicated baseline of 25.1 (+3.7) mmHg to 15.9 (+5.2) mmHg at the 12-month visit (n=52). The mean baseline number of IOP-lowering medications was 3.5 (±1) vs. an average use of 1.7 (±1.5) medications at 12 months. Allergan plans to launch the system in early 2017. Read more.

  • Unregulated Cosmetic Iris Implants Inserted Outside U.S. & European Union Causing Severe Ocular Complications
    The American Society of Cataract and Refractive Surgery, the European Society of Cataract and Refractive Surgeons, the Asia-Pacific Association of Cataract & Refractive Surgeons and other groups, have issued a clinical alert strongly advising against the implantation of any anterior chamber cosmetic iris implants that haven’t been subject to rigorous regulatory approval and thoroughly studied in appropriate clinical trials. Unlike functional artificial iris devices, which are designed to be placed in the capsular bag or ciliary sulcus of pseudophakic eyes, "color-changing" iris implants are being placed into the anterior chamber of young phakic individuals over a healthy iris and in direct contact with angle structures, the groups caution in the alert. Two case series and several case reports have described severe and irreversible complications of these implants, even following explantation. The most frequent problems include corneal decompensation, sectoral iris atrophy, glaucoma, cataract and uveitis. Many individuals in the two case series required secondary surgeries including corneal transplantation, glaucoma tube shunt implantation, iris repair (in some instances necessitating a HumanOptics sulcus artificial iris implant and cataract surgery). These complications often develop months to years after cosmetic iris implantation.

  • Santen Releases Phase III SAKURA Program Topline Results
    Santen Pharmaceutical announced topline results from its SAKURA global clinical development program designed to confirm the efficacy, safety and optimal dose between three active doses of sirolimus intravitreal injection as monotherapy for individuals with non-infectious uveitis of the posterior segment. The program met its objective, demonstrating that OPSIRIA (440-µg sirolimus injection, development code: DE-109) can effectively and safely reduce intraocular inflammation (as measured by vitreous haze). Findings from SAKURA Study 1, the first Phase III trial, established the efficacy and safety of OPSIRIA as a potential treatment for non-infectious uveitis of the posterior segment. In SAKURA Study 2, the second Phase III trial, the difference in the effect (vitreous haze) between the low dose of sirolimus injection (44 µg) and OPSIRIA was not statistically significant, though clinical findings provide supportive evidence confirming the efficacy of the product. Based on the totality of the data from the SAKURA Program, Santen plans to file a New Drug Application to the U.S. Food and Drug Administration. Read more.

  • Sun Pharma Launches First Branded Ophthalmic Product in United States
    Sun Pharma launched BromSite (bromfenac ophthalmic solution) 0.075% in the U.S. market. A nonsteroidal anti-inflammatory drug indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery, BromSite will be marketed by Sun Ophthalmics, the company’s branded ophthalmic business division. BromSite is the first branded product launched by the company in the United States, following its focus on specialty business. Approved by the U.S. Food and Drug Administration on April 8, BromSite (bromfenac ophthalmic solution) 0.075% is the first NSAID approved to prevent ocular pain and treat inflammation in the eye following cataract surgery. Read more.

  • EyePromise Launches New Website
    EyePromise, owned by ZeaVision Holdings, launched a new website to improve the user experience and help consumers reach solutions quickly and easily. The site demonstrates a streamlined purchasing experience, robust account management features and modern design, coupled with EyePromise resources. Consumers can manage payments, create passwords, and manage orders and delivery information as they would on their favorite shopping sites. Products are segmented into categories to make searches easier, and a new design optimizes organization and efficiency. Read more.

  • Zeiss Gets FDA Nod for SS-OCT Posterior Ocular Imaging With PLEX Elite 9000
    Having received the first United States FDA clearance for ocular coherence tomography angiography technology in September 2015, Zeiss now has received the first FDA clearance for swept-source OCT imaging technology for posterior ocular structures with Zeiss Plex Elite 9000. The SS-OCT and OCTA platform was designed for advanced retina research and is at the core of the Advanced Retina Imaging Network, led by Philip J. Rosenfeld, MD, PhD. The network is a global consortium of clinicians and scientists from around the world working at the forefront of retinal disease research focused on exploring new clinical applications for the diagnosis and treatment of eye disease, and advancing OCT innovation. The FDA clearance will help U.S. members of the network more easily enroll individuals and may facilitate faster Institutional Review Board review for protocol approval of research. The wide-field high-resolution visualization provided by the SS-OCT and OCTA imaging of the platform expands clinicians’ ability to examine the critical microstructures and microvasculature of the posterior segment at any depth of interest from vitreous to sclera. Read more.

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