Review of Ophthalmology Online



Vol. 22, #9  •   Monday, March 1, 2021


In this Issue:



Characteristics Associated with MIGS Use

Minimally-invasive glaucoma surgery is increasingly performed at the time of cataract extraction, so understanding the demographic and clinical characteristics of patients undergoing MIGS procedures may provide insight into patient selection, researchers wrote. Their study evaluated racial-ethnic and other differences in the use of MIGS in individuals with cataract and open-angle glaucoma.

This retrospective cohort study using IRIS (Intelligent Research in Sight) Registry data included U.S. patients ≥40 years of age with a diagnosis of OAG and no history of MIGS or cataract surgery who underwent cataract extraction, with or without MIGS between 2013 and 2017.

Multivariable logistic regression models were used to calculate odds ratios (ORs) and confidence intervals. Variables assessed included age, sex, race-ethnicity, disease severity, insurance type, census region, comorbidity and cup-to-disc ratio.

Here were some of the findings:
• The odds of MIGS utilization was greater among patients who were:
   o >60 years (OR, 1.10 [CI, 1.05 to 1.16]);
   o African American (OR, 1.11 [CI, 1.07 to 1.15]); vs. White, Medicare recipients (OR, 1.12 [CI, 1.10 to 1.15]) who were privately insured, and living in the Midwest (OR, 1.32 [CI, 1.28 to 1.36]) or Northeast (OR, 1.26 [CI, 1.22 to 1.30]); vs. in the South.
• Having moderate, rather than mild, glaucoma (OR, 1.07 [CI, 1.04 to 1.11]) and a higher CDR (OR for 0.5 to 0.8 vs. <0.5, 1.24 [CI, 1.21 to 1.26]; OR for >0.8 to 1 vs. <0.5, 1.27 [CI, 1.23 to 1.32]) were also each associated with increased odds of MIGS use.
• MIGS was less likely in females (OR, 0.96 [CI, 0.94 to 0.98]); patients taking five to seven glaucoma medications (OR, 0.94 [CI, 0.90 to 0.99]) vs. one to two medications; and patients with severe vs. mild glaucoma (OR, 0.64 [CI, 0.61 to 0.67]).

Researchers wrote, to their knowledge, the IRIS Registry contained the largest cohort of U.S. patients with MIGS procedures reported to date. They added that their analysis highlighted the importance of capturing race-ethnicity data and other pertinent patient characteristics in electronic health records to provide insights into practice patterns. In addition, they wrote, such data can be used to assess the long-term performance of MIGS and other procedures in various patient populations.

SOURCE: Olivier MMG, Smith O, Croteau-Chonka CC, et al. Demographic and clinical characteristics associated with minimally invasive glaucoma surgery use: An IRIS Registry retrospective cohort analysis. Ophthalmology 2021; Feb 15. [Epub ahead of print].


VA Outcomes Following Anti-VEGF Treatment for Macular Edema Secondary to CRVO

Investigators evaluated whether baseline demographic factors, and clinical and optical coherence tomography characteristics predicted visual acuity outcomes in patients receiving anti-VEGF therapy for macular edema due to central retinal vein occlusion.

A post hoc analysis of the randomized noninferiority trial (Lucentis, Eylea, Avastin in CRVO), the LEAVO study, from December 12, 2014, through December 16, 2016, was carried out across 44 UK National Health Service ophthalmology departments.

Data on 267 participants with baseline best-corrected mean visual acuity range of 19 to 78 Early Treatment Diabetic Retinopathy Study letter scores (approximate Snellen equivalent 20/32 to 20/320) who had central subfield thickness (CST) ≥320 μm on Spectralis OCT (Heidelberg Engineering) were analyzed.

Study participants were randomized to receive repeated intravitreal injections of ranibizumab [0.5 mg/50 μl], aflibercept [2 mg/50 μl] or bevacizumab [1.25 mg/50 μl], and a protocol-driven pro re nata retreatment regimen of four to eight weekly injections up to week 100, after four mandated weekly loading injections.

Main outcomes and measures were change in BCVA, and percentage of patients gaining ≥10 letters and achieving BCVA letter score >70 letters at 52 and 100 weeks.

The analysis was adjusted for treatment effects and confirmed by sensitivity analysis. Here were some of the findings:
• Age ≥75 years was a poor predictor for all three visual outcomes.
• Lower baseline BCVA predicted 10-letter gainers and higher gains in BCVA, although it was a poor predictor of achieving >70 ETDRS letters.
• None of the baseline OCT morphological characteristics except ellipsoid zone integrity influenced visual outcomes.
• Both baseline CST and total macular volume showed a non-linear relation to 10 letter gainers, with CST >900 µm being a poor prognostic indicator.
• Baseline CST and macular volume didn’t predict mean change in BCVA or BCVA >70 letters at 52 and 100 weeks.

Investigators found younger age, higher baseline BCVA and a definitely intact subfoveal ellipsoid zone at presentation were predictors of BCVA score >70 letters at 100 weeks.

SOURCE: Sen P, Gurudas S, Ramu J, et al. Predictors of visual acuity outcomes following anti-VEGF treatment for macular edema secondary to central retinal vein occlusion. Ophthalmol Retina 2021; Feb 18. [Epub ahead of print].


Predicting Edema Resolution After DMEK for Fuchs’ Dystrophy Using Scheimpflug Tomography

Scientists wrote that predicting the extent of corneal edema resolution after Descemet’s membrane endothelial keratoplasty may help make preoperative decisions by identifying patients who may benefit from restoring endothelial function. They aimed to develop and validate a predictive model for edema resolution after DMEK using Scheimpflug tomographic imaging.

Two prospective studies recruited participants with advanced Fuchs’ dystrophy at a university-based tertiary referral center between July 1, 2017, and August 31, 2019. Analyses were designed in November 2019 and completed on June 30, 2020. Development of a predictive model using linear least absolute shrinkage and selection operator regression was conducted in a derivation cohort (100 eyes). Overall performance, discrimination and calibration were tested in the separate validation cohort (32 eyes).

The following preoperative Scheimpflug parameters and patient-reported visual disability were considered potential predictors of edema resolution: (1) tomographic features (irregularity of lines of equal corneal thickness, displacement of the thinnest point of corneal thickness from the inferior-temporal quadrant and absolute amount of focal posterior corneal depression); (2) standardized anterior and posterior corneal backscatter; (3) preoperative central corneal thickness; and (4) Fuchs’ dystrophy-specific visual disability.

The main outcome measure was decrease in central corneal thickness after DMEK indicative of edema resolution.

Of the 88 patients included in the analysis, 54 were women (61 percent), and the median age was 68 years (interquartile range, 59 to 76 years). Here were some of the findings:
• A median of 13 months after DMEK (IQR, 9 to 16 months), median corneal thickness was 77 μm lower (IQR, 51 to 94 μm) in the derivation cohort and 75 μm lower in the validation cohort (IQR, 54 to 96 μm) than before surgery.
• Per 10 μm edema resolution, eyes gained 0.66 Early Treatment Diabetic Retinopathy Study letters (CI, 0.09 to 1.23) in best-corrected visual acuity.
• Three tomographic features were present in 68 of 100 eyes (68 percent) in the derivation cohort and in 18 of 32 eyes (56 percent) in the validation cohort before DMEK and in only one of 132 eyes (1 percent) after DMEK.
• To predict edema resolution after DMEK based on preoperative assessment, five variables were selected by the statistical learning algorithm: nonparallel isopachs; focal posterior depression; anterior and posterior corneal backscatter; and central corneal thickness.
• In the separate validation cohort, the model showed high overall performance, discrimination and calibration.

Scientists reported that the post hoc analyses of prospective cohorts supported a model for use in the prediction of edema resolution after DMEK using Scheimpflug measurement to identify patients benefitting most from DMEK.

SOURCE: Zander D, Grewing V, Glatz A, et al. Predicting edema resolution after descemet membrane endothelial keratoplasty for Fuchs dystrophy using scheimpflug tomography. JAMA Ophthalmol 2021; Feb 18. [Epub ahead of print].


A Novel Method to Detect & Monitor Retinal Vasculitis Using SS-OCTA

Researchers introduced a novel method for assessment of retinal vasculitis using swept-source optical coherence tomography angiography, as part of a retrospective case series.

Patients with retinal vasculitis were identified among a clinic population and imaged with 12 x 12 mm SS-OCTA scans centered on the fovea. A custom retina segmentation superimposed the color retinal thickness map on a modified en-face flow scan. Findings from en-face flow scans were correlated with localized perivascular retinal thickening on B-scans. Results from SS-OCTA were compared to fluorescein angiography to examine the proportion of perivascular thickening to retinal vascular leakage or staining.

Twenty-one patients with retinal vasculitis underwent same-day FA and SS-OCTA. Here were some of the findings:
• Visible retinal vascular leakage/staining on FA corresponded to increased perivascular retinal thickness on SS-OCTA in 17 patients.
• Five patients had a second exam with same-day FA and SS-OCTA after treatment of the vasculitis, three of whom showed improved retinal vascular leakage/staining on post-treatment FA as well as decreased perivascular retinal thickness on SS-OCTA scans.

Researchers concluded that SS-OCTA detected structural retinal thickening secondary to inflammatory retinal vascular leakage. They advised that further studies would be needed to confirm if OCTA can serve as a semi-quantitative alternative to FA to diagnose and monitor the response to treatment in patients with retinal vasculitis.

SOURCE: Noori J, Shi Y, Yang J, et al. A novel method to detect and monitor retinal vasculitis using swept source OCT angiography. Ophthalmol Retina 2021 ; Feb 18. [Epub ahead of print].




Industry News

Researchers Analyze Genes in More Than 34,000 People with Glaucoma, Identify 44 New Genetic Variants

In the largest genome-wide association study of glaucoma comparing the genes of 34,179 people with glaucoma to 349,321 control subjects, an international consortium of researchers identified 44 new gene loci and confirmed 83 previously reported loci linked to glaucoma. The findings were published February 24 in Nature Communications. For the first time in a glaucoma genome-wide association study, a cross-ancestry comparison was performed looking at genetic data from people of European, African and Asian descent. The researchers found the majority of loci that contribute to glaucoma were consistent across all three groups. View the study.



AcuFocus Submits FDA Premarket Approval Application for the IC-8 IOL

AcuFocus submitted a premarket approval application to the FDA for its IC-8 small-aperture IOL, an aspheric monofocal lens that features an embedded filter with a small central aperture. The company says that, using wavefront-filtering small-aperture optics, the lens is designed to mitigate the harmful visual effects of unfocused peripheral light, allowing only central light rays to focus on the retina, and to deliver continuous extended depth of focus. Learn about the company.



Allergan Submits NDA for Topical Presbyopia Treatment

Allergan submitted a New Drug Application to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021. The NDA is based primarily on data from two Phase III GEMINI 1 and GEMINI 2 clinical studies, which evaluated the efficacy, safety and tolerability of AGN-190584 (pilocarpine 1.25%). In both studies, Allergan says that AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision in mesopic conditions without a loss of distance vision vs. the vehicle. No serious adverse events were observed in any of the study-drug participants. Read more.

Stealth Completes Enrollment of Phase II Study in Dry AMD with GA

Stealth BioTherapeutics announced that the company completed enrollment for ReCLAIM-2 (SPIAM-202) and expects topline data in the first half of 2022. ReCLAIM-2 is a phase II randomized, double-masked, placebo-controlled study to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry age-related macular degeneration with geographic atrophy. The ReCLAIM-2 study completed enrollment with 176 patients. The primary endpoint of the 48-week study will measure low-luminance best-corrected visual acuity. Secondary functional endpoints are change in low-luminance reading acuity and best-corrected visual acuity. Read more.



Complimentary CME Education Videos




B+L Launches Alaway Preservative Free Antihistamine Eye Drops

Bausch + Lomb announced the U.S. launch of Alaway Preservative Free (ketotifen fumarate ophthalmic solution 0.035%) antihistamine eye drops, the first over-the-counter preservative-free antihistamine eye itch relief drop approved by the FDA. Alaway Preservative Free is a new, OTC prescription-strength formula formulated to block the release of histamines and reduce allergic inflammation. Alaway provides relief within minutes and lasts up to 12 hours with one dose. Read more.

13th Annual Swing Fore Sight Golf Tournament at Vision Expo East

Prevent Blindness announced the 2021 Prevent Blindness Swing Fore Sight Golf Tournament will take place June 2 at the Orange County National Golf Center and Lodge in Orlando in conjunction with Vision Expo East registration and lunch. All proceeds will support Prevent Blindness’ sight-saving mission. The Swing Fore Sight golf committee is co-chaired by Michael Block of Block Business Group and Joe Savarese of Jobson Interactive. All sponsorship levels are now available. Read more.












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