From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
Evaluation of a POAG Prediction Model
Researchers assessed whether long-term intraocular pressure variability data improved a prediction model for the development of primary open-angle glaucoma in individuals with untreated ocular hypertension.
The post hoc secondary analysis of two randomized clinical trials included data from 709 of 819 participants in the observation group of the Ocular Hypertension Treatment Study followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study followed up from January 1, 1997, to September 30, 2003. Data analyses were completed between January 1, 2019, and March 15, 2020.
The original prediction model for the development of POAG included the following baseline factors: age, IOP, central corneal thickness, vertical cup-disc ratio and pattern SD. This analysis tested whether substitution of baseline IOP with mean follow-up IOP, SD of IOP, maximum IOP, range of IOP or coefficient of variation IOP would improve predictive accuracy.
Researchers used the C statistic to compare the predictive accuracy of multivariable landmark Cox proportional hazards regression models for the development of POAG.
Data from the OHTS consisted of 97 POAG endpoints from 709 of 819 participants (416 [58.7 percent] women; 177 [25 percent] African American and 490 [69.1 percent] white; mean age, 55.7 ±9.59 years; median [range] follow-up, 6.9 [0.96 to 8.15] years).
Data from the EGPS consisted of 44 POAG endpoints from 397 of 500 participants in the placebo group (201 [50.1 percent] women; 397 [100 percent] white; mean age, 57.8 ±9.76 years; median [range] follow-up, 4.9 [1.45 to 5.76] years). Here were some of the findings:
- The C statistic for the original prediction model was 0.741.
- When a measure of follow-up IOP was substituted for baseline IOP in this prediction model, the C statistics were as follows:
- mean follow-up IOP, 0.784;
- maximum IOP, 0.781;
- SD of IOP, 0.745;
- range of IOP, 0.741; and
- coefficient of variation IOP, 0.729.
- The C statistics in the EGPS were similarly ordered.
- No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio and pattern SD, increased the C statistic by more than 0.007 in either cohort.
Researchers determined that evidence from the OHTS and the EGPS suggested that long-term variability didn’t add substantial explanatory power to the prediction model as to which individuals with untreated ocular hypertension would develop POAG.
SOURCE: Gordon MO, Gao F, Beiser Huecker J, et al. Evaluation of a primary open-angle glaucoma prediction model using long-term intraocular pressure variability data: A secondary analysis of 2 randomized clinical trials. JAMA Ophthalmol 2020; June 4. [Epub ahead of print].
Complimentary CME Education Videos
Results from the Duke Glaucoma Registry Study
Investigators analyzed rates of structural and functional change in a large clinical population of glaucoma and glaucoma suspect patients, as part of a retrospective cohort from the Duke Glaucoma Registry, a large database of electronic medical records of patients from the Duke Eye Center and satellite clinics.
A total of 29,548 spectral-domain optical coherence tomography, and 19,812 standard automated perimetry (SAP) tests from 6,138 eyes of 3,669 patients with at least six months of follow-up, two good-quality SD-OCT peripapillary retinal nerve fiber layer tests and two reliable SAP tests were included. Investigators obtained rates of change for the two metrics using linear mixed models, categorized according to pre-established cutoffs, and analyzed according to the severity of the disease. Here were some of the findings:
- Average rates of change were -0.73 ±0.80 μm/year for global RNFL thickness and -0.09 ±0.36 dB/year for SAP mean deviation (MD).
- A total of 26.6 percent of eyes were classified as having at least a moderate rate of change by SD-OCT vs. 9.1 percent by SAP (p<0.001).
- In eyes with severe disease, 31.6 percent were classified as progressing at moderate or faster rates by SAP vs. 26.5 percent by SDOCT (p=0.055).
- Most eyes classified as fast by SD-OCT were classified as slow by SAP and vice versa.
Investigators wrote that although most individuals under routine care had slow rates of progression, a substantial proportion had rates that could potentially result in major losses if sustained over time. They added that both structural and functional tests should be used to monitor glaucoma, and SD-OCT still has a relevant role in detecting fast progressors in advanced disease.
SOURCE: Jammal AA, Thompson AC, Mariottoni EB, et al. Rates of glaucomatous structural and functional change from a large clinical population: The Duke Glaucoma Registry Study. Am J Ophthalmol 2020; May 22. [Epub ahead of print].
Complimentary CME Education Videos
Changes in Choroidal Thickness from CNV
Scientists evaluated topographic changes in choroidal thickness during development of choroidal neovascularization in treatment-naive age-related macular degeneration and tested the value of such changes as a predictive tool of CNV development.
This retrospective cohort included 86 eyes that developed CNV from intermediate AMD, 43 eyes with intermediate AMD and 36 eyes without AMD. Patients with intermediate AMD underwent spectral-domain optical coherence tomography using enhanced depth imaging mode every six months until CNV was detected. Choroidal neovascularization was localized to one of the subfields of the Early Treatment of Diabetic Retinopathy Study grids on fluorescein angiography. The average choroidal thickness of each subfield was calculated. Here were some of the findings:
- The choroidal thickness of the subfield where CNV developed at first clinical detection significantly increased compared with that six months before (p=0.000 for central, p=0.001 for superior parafoveal, p=0.002 for temporal parafoveal, p=0.002 for inferior parafoveal and p=0.001 for nasal parafoveal subfield).
- In eight individuals who visited unexpectedly three months before CNV development in central subfield, the choroidal thickness of the central subfield increased significantly compared with that six months before CNV development (p=0.001).
Scientists found that choroidal neovascularization development accompanied choroidal thickening of the corresponding subfield. They added that regular measurement of choroidal thickness may assist in prediction of CNV.
SOURCE: Park JY, Kang M-J, Kim BGi, et al. Topographic changes in choroidal thickness in age-related macular degeneration during the development of active choroidal neovascularization. Ophthalmology Retina 2020; May 18. [Epub ahead of print].
Association of CRP Levels with ARMS2 and CFH Variants in AMD
Researchers assessed whether plasma high-sensitivity C-reactive protein (hs-CRP) levels were associated with exudative age-related macular degeneration as well as variants of ARMS2 A69S and CFH I62V in patients with exudative AMD.
They conducted a case-control study comparing CRP with exudative AMD including individuals with polypoidal choroidal vasculopathy, typical AMD, retinal angiomatous proliferation and CRP. Researchers measured plasma CRP from peripheral blood using latex nepherometry for all participants. They performed genotyping of ARMS2 A69S and CFH I62V for all patients with exudative AMD using TaqMan technology. Here were some of the findings:
- Among 125 individuals with exudative AMD, including 31 with typical neovascular AMD, 73 with PCV and 21 with RAP lesions and 150 controls, CRP levels were higher in exudative AMD than in controls (p=2.7 × 10 to 5).
- No significant differences were found in hs-CRP levels among AMD subtypes.
- Neither variants of ARMS2 nor CFH were associated with hs-CRP levels in patients with exudative AMD.
- A multiple regression analysis revealed that male sex, presence of exudative AMD and presence of cardiovascular diseases were associated with increased plasma hs-CRP.
Researchers found that plasma hs-CRP was elevated independent of variants of ARMS2 A69S and CFH I62V in patients with exudative AMD.
Source: Shijo T, Sakurada Y, Fukuda Y, et al. Association of CRP levels with ARMS2 and CFH variants in age-related macular degeneration. Ophthalmology Retina 2020; June 7. [Epub ahead of print].
ARVO 2020: Genentech Presents Second Wave of Data
Genentech and Roche will be presenting a second round of findings from this year’s virtual Association for Research in Vision and Ophthalmology meeting. The findings will focus on the companies’ Port Delivery System with ranibizumab (PDS), a new anti-HtrA1 molecule for geographic atrophy and the Personalized Healthcare program. View the video abstracts.
In addition, the ARVO Foundation’s new Genentech Career Development Award for Underrepresented Minority Emerging Vision Scientists will open to applicants on July 1. Learn more.
FDA Grants 510(k) Clearance for Vasoptic's Retinal Imaging Device
Vasoptic Medical received 510(k) clearance from the FDA to market its XyCAM RI—a noninvasive retinal imager designed to capture and provide dynamic blood flow information for clinical use. The company says the XyCAM RI enables ophthalmologists to rapidly assess the vascular status of the retina. Read more.
J&J Vision to Present First Pediatric Myopia Findings at ARVO’s Virtual Annual Meeting
Johnson & Johnson Vision will present clinical research findings from its comprehensive myopia clinical research program with the Singapore Eye Research Institute (SERI) and Singapore National Eye Centre (SNEC), as well as new data on contact lens and surgical innovations, at the Association for Research in Vision and Ophthalmology Annual Meeting, which is being held as a virtual congress. Presentations will be published on June 15. View studies and author videos here.
The company also announced clinical research findings on myopia progression in children and child myopia screening and education in the Asia Pacific region. View the study abstract.
Aerie Pharmaceuticals Appoints Dr. McDonnell to Board
Aerie Pharmaceuticals announced that Wilmer’s Peter J. McDonnell, MD, was appointed to the company’s board of directors and will also be a member of both the Nominating and Corporate Governance and Compensation Committees of the board. Dr. McDonnell, a corneal specialist, has served as the William Holland Wilmer Professor of Ophthalmology and director of the Wilmer Eye Institute at the Johns Hopkins University School of Medicine since 2003. Read more.
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve and Spinal Cord
The U.S. Food and Drug Administration recently approved Viela Bio’s Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Uplizna is only the second approved treatment for the disorder. Read more.
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