From the editors of Review of Ophthalmology:
Monday, November 19, 2018
NOVEMBER IS DIABETIC EYE DISEASE AWARENESS MONTH
In this issue: (click heading to view article)
High-dose Steroids in Bacterial Keratitis
Researchers described the usage patterns of steroids in bacterial keratitis and analyzed the effect of steroids on visual outcomes, as part of a single-center retrospective review of individuals with culture-positive bacterial keratitis treated between 1999 and 2015 at Princess Alexandra Hospital (Brisbane, Australia).
Researchers also assessed the statistical heterogeneity by the chi-square test. Individuals with culture-positive bacterial keratitis were identified through the Queensland Pathology Database, and clinical information was gathered through a medical records review. High-dose steroid treatment was classified as six or more drops of a steroid a day started within seven days of corneal scraping. The outcome of an individual’s episode of keratitis was classified as good if final visual acuity was 6/12 (20/40) or better, and poor if it was 6/60 (20/200) or worse or required a corneal transplant; otherwise it was classified as average. Researchers evaluated microbiological and clinical variables' associations with outcomes in univariate analyses. They examined variables significant at p<0.1 in a multivariate ordinal logistic regression analysis created with forward variable selection with forced inclusion of steroid treatment (high, regular, low dose and none).
A total of 328 individuals were included from 1,002 reviewed charts. Of these, 164 (50 percent) were treated with steroids. Factors significantly associated with outcomes in the multivariate model were high-dose steroid treatment, visual acuity on presentation, age group, cause of keratitis, and infiltrate size and location. The odds ratio of better outcomes with high-dose steroids was 5.49 (CI, 1.6 to 19.0, p=0.007).
Researchers concluded that high-dose steroid treatment was significantly associated with better visual outcomes in individuals with culture-positive bacterial keratitis in the case series.
SOURCE: Green M, Hughes I, Hogden J, et al. High-dose steroid treatment of bacterial keratitis. Cornea 2018; Oct 24. [Epub ahead of print].
Choriocapillaris Flow Features & Choroidal Vasculature in Fellow Eyes of Acute CSC Cases
Investigators analyzed the characteristics of choriocapillaris flow based on the underlying choroidal vasculature in fellow eyes with central serous chorioretinopathy, in 57 cases with CSC and normal controls.
They evaluated characteristics of choriocapillaris flow using swept-source optical coherence tomography angiography, and divided the choroidal layer into vascular and stromal beds according to the choroid vessels on en-face OCT images. And they compared the flow void area and mean vascular density of the choriocapillaris by the underlying choroidal beds in the CSC and control group. Some of the results included the following:
- The mean vascular density of the choriocapillaris in the CSC group wasn’t different from that of the control group (p=0.289).
- The flow void area was more frequently found in the CSC group (59.6 percent) than in controls (29.8 percent, p=0.002).
- The presence of the flow void area in the CSC group was associated with greater macular choroidal thickness (p=0.004).
- In the CSC group, the mean flow void area and ratio of the choriocapillaris over the vascular bed were larger than those over the stromal bed (all p<0.001).
Investigators determined that the location of the flow void area of the choriocapillaris was associated with the distribution of the underlying choroidal vessels, suggesting that the underlying choroidal vessels might affect choriocapillaris perfusion in pachychoroid eyes.
Source: Yun C, Huh J, Ahn SM, et al. Choriocapillaris flow features and choroidal vasculature in the fellow eyes of patients with acute central serous chorioretinopathy. Graefes Arch Clin Exp Ophthalmol 2018; Nov. 5. [Epub ahead of print].
Association of Macular VF Measurements with Glaucoma Staging Systems
Scientists wrote that macular function is important for daily activities but is underestimated with 24-2 visual fields, which are often used to classify glaucoma severity. They looked at whether current glaucoma staging systems underestimate glaucoma severity by not detecting macular damage, as part of a cross-sectional study carried out in a glaucoma referral practice.
The eyes of participants with manifest glaucoma and 24-2 mean deviation (MD) better than -6 dB were included. All participants were tested with 24-2 and 10-2 VFs, and spectral-domain optical coherence tomography of the optic disc and macula.
Macular damage was based on the topographic agreement between VF results and retinal ganglion cell plus inner plexiform layer probability plots. Scientists examined classifications from the Hodapp-Parrish-Anderson, VF index and Brusini staging systems and compared them with VF and SD-OCT results. Main outcomes and measures included the association between the presence of macular damage and glaucoma severity scores.
A total of 57 eyes of 57 participants were included; 33 subjects (57 percent) were women, and 43 (75 percent) were white, with a mean (SD) age of 57 (14) years. The results:
• Forty-eight eyes (84 percent [CI, 72 to 92 percent]) had macular damage by the study definition.
• Eyes with macular damage had mean (SD) of -2.5 (1.8) for 24-2 MD; -3 (2.4) dB for 10-2 MD; and 94.2 percent (4.5 percent) for VFI.
• The HPA system classified 70 percent (CI, 55 to 83 percent) of eyes with macular damage as having early defects; the VFI system classified 81 percent (CI, 67 to 91 percent), and the Brusini system classified 68 percent (CI, 53 to 81 percent).
Scientists wrote that the findings suggested that current glaucoma staging systems based on 24-2 or 30-2 VFs underestimate disease severity and the presence of macular damage. They added that, if these results are confirmed and generalized to other participants, new systems using macular measures (from 10-2 and SD-OCT results) might improve staging of glaucoma severity.
SOURCE: De Moraes CG, Sun A, Jarukasetphon R, et al, et al. Association of macular visual field measurements with glaucoma staging systems. JAMA Ophthalmol 2018; Nov. 8. [Epub ahead of print].
24-hour IOP Control with Fixed-dose Combination Brinzolamide 1%/Brimonidine 0.2%
Researchers sought to determine the intraocular pressure-lowering effect of fixed-combination brinzolamide 1%/brimonidine 0.2% (Simbrinza, Novartis) over a 24-hour period, as part of a prospective, multicenter, double-masked, parallel-group clinical trial conducted at 16 academic and non-academic sites and partially funded by Novartis. Two of the study authors are Novartis employees.
Participants included subjects with open-angle glaucoma or ocular hypertension ages ≥18 years, with mean baseline IOP measurements in at least one eye of ≥21 and <28 mmHg.
Duplicate, mean pneumatonometer IOP measurements were collected every two hours over a 24-hour period in controlled lighting conditions in overnight facilities. Daytime (8 a.m. to 8 p.m.) IOP measurements were collected in a sitting position, and nocturnal (10 p.m. to 6 a.m.) IOP measurements were gathered in a supine position. Baseline 24-hour IOP was measured in untreated subjects after a washout phase (up to four weeks) and eligibility phase. Following the baseline visit, subjects were randomized 1:1 to receive masked BBFC or vehicle, one drop three times daily (8 a.m., 3 p.m., 10 p.m.) for four weeks. At week four, IOP measurements were repeated under the same conditions. The main outcome measure was the mean change from baseline in 24-hour IOP at week four. The results:
• Of 125 subjects randomized, 123 (98 percent; BBFC, n=62; vehicle, n=61) completed the study. No subjects randomized to BBFC discontinued from the study.
• At week four, BBFC-treated eyes had significantly reduced mean 24-hour IOP vs. vehicle (least squares mean difference (CI, -2.5 [-3.3, -1.7]; p< 0.001); daytime (CI, -3.4 [4.3, -2.6]; p<0.001) and nocturnal (CI, -1.2 [-2.3, 0]; p=0.053) reductions were observed.
• The mean change from baseline was significantly different between BBFC- and vehicle-treated eyes at all daytime points, and three of five nocturnal time points (10 p.m., 12 a.m., 6 a.m.; secondary endpoint).
• The frequency of adverse events was similar between treatment groups; in the BBFC arm, ocular hyperemia, corneal abrasion and dysgeusia were the most frequently reported, consistent with events described in the drug label.
Researchers noted that BBFC demonstrated significantly superior 24-hour IOP-lowering efficacy vs. vehicle following four weeks of t.i.d. treatment in subjects with OAG or OHT.
SOURCE: Weinreb RN, Bacharach J, Fechtner RD, et al. 24-hour intraocular pressure control with fixed-dose combination brinzolamide 1%/brimonidine 0.2%: a multicenter, randomized trial. Ophthalmology 2018 Nov 4. [Epub ahead of print].
Acucela Initiates Phase III Study of Emixustat for Stargardt’s Disease
Acucela announced the first patient was enrolled in a study to evaluate Acucela’s leading drug candidate, emixustat, in subjects with macular atrophy secondary to Stargardt’s disease. In the multicenter, randomized, double-masked, placebo-controlled Phase III clinical study, subjects will be randomly assigned to emixustat 10 mg or placebo (2:1 ratio) once daily for 24 months. The primary objective is to determine if emixustat reduces the rate of macular atrophy progression compared with placebo in subjects with Stargardt’s disease. Read more.
AsclepiX Raises $5M in New Funding
AsclepiX Therapeutics raised $5 million in convertible note funding, led by Barer & Son Capital, to accelerate development of its AXT107 treatment for diabetic macular edema and wet age-related macular degeneration. AsclepiX is based on a novel peptide platform with a mechanism of action that targets multiple pathways, including vascular endothelial growth factor A and Tie2. Read more.
Singapore National Eye Centre, Singapore Eye Research Institute & J&J Vision Aim to Halt Global Myopia Epidemic
The Singapore National Eye Centre, the Singapore Eye Research Institute and Johnson & Johnson Vision announced a $26.35 million research collaboration to tackle myopia. The first-of-its-kind public-private strategic partnership in Asia focused on myopia will create a deeper understanding of how the condition develops, how it progresses and how it may be intercepted. It aims to develop predictive tools to identify those who may be at risk of developing high myopia, and to conduct research on the underlying mechanisms of myopia, advance novel therapies, and discover and validate methods to prevent the onset and progression of the condition. Read more.
OWL Award Recipients Recognized for Advancing Diversity in Ophthalmology Leadership
OWL: Advancing Diversity in Leadership announced the winners of the 2018 OWL Awards at the organization’s Signature Event, held Oct. 28 during the American Academy of Ophthalmology annual meeting. This year’s winners included:
• Rising Star Award – Jennifer Loh, MD, a board-certified comprehensive ophthalmologist practicing in the south Miami area;
• Visionary Leader Award – Allison Shuren, partner and co-chair of the Life Sciences and Healthcare Regulatory Group at the law firm of Arnold & Porter;
• Catalyst Award – Brad Fundingsland, president of The Fundingsland Group, which promotes medical education through large-scale evidence-based programming
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