From the editors of Review of Ophthalmology:
JANUARY IS GLAUCOMA AWARENESS MONTH
In this issue: (click heading to view article)
Automated Anterior Chamber Angle Measurement for UBM Using Deep Learning
Investigators developed a software package, ResNet-18, for automated measuring of the trabecular-iris angle (TIA) using ultrasound biomicroscopy. UBM images were collected, and specialists manually measured the TIA.
Investigators used different models as the convolutional neural network (CNN) for the automatic TIA measurement. The root-mean-squared error helped explain variance (EVA), and mean absolute percentage error (MAPE) helped investigators evaluate the performance of these models. Investigators calculated interobserver reproducibility, coefficient of variation (CV) and intraclass correlation coefficient (ICC) to evaluate the consistency between the manual measured and the model predicted values. Here were some of the findings:
• ResNet-18 had the best performance in RMSE, EVA and MAPE among all five models.
• The average difference between the angles measured manually and by the model was:
o -0.46 ±3.97 degrees for all eyes;
o -1.67 ±5.19 degrees for open angles; and
o 0.75 ±1.43 degrees for narrow angles.
• The CV, ICC and reproducibility of the total TIA measurements were, respectively:
o 6.8 percent, 0.95 and 6.1 degrees for all angles;
o 6.4 percent, 0.99 and 7.7 degrees for open angles; and
o 8.8 percent, 0.93 and 4 degrees for narrow angles.
Investigators wrote that preliminary results showed that this fully automated anterior chamber angle measurement method could achieve high accuracy and good consistency with manual measurement results, and offer potentially significant benefits for future clinical practice.
SOURCE: Li W, Chen Q, Jiang Z, et al. Automatic anterior chamber angle measurement for ultrasound biomicroscopy using deep learning. J Glaucoma 2019; Nov 26. [Epub ahead of print].
Presbyopia-correcting IOL Implantation After DMEK for Fuchs’ Dystrophy
Scientists assessed outcomes of presbyopia-correcting intraocular lens implantation after Descemet’s membrane endothelial keratoplasty in individuals with Fuchs’ endothelial corneal dystrophy, as part of a retrospective, single-center study.
They evaluated a consecutive series of individuals with Fuchs’ dystrophy who received presbyopia-correcting IOLs after DMEK. The main outcomes were corrected distance visual acuity, uncorrected distance visual acuity, uncorrected near visual acuity and refractive error.
Fourteen extended depth of focus and two bifocal multifocal IOLs were implanted in 16 eyes of eight individuals (five women and three men; ages 47 to 68 years). Fourteen IOLs were spherical, and two were toric. Here were some of the findings:
o the median corrected distance visual acuity was 20/20 (range, 20/15 to 20/25);
o the median binocular uncorrected distance visual acuity was 20/25
(range, 20/15 to 20/25);
o the median binocular uncorrected near visual acuity was 20/20
(range, 20/20 to 20/50); and
o the median manifest spherical equivalent refraction was 0.05 D
(range, -0.75 to +0.75 D).
• In one patient, implantation of toric EDOF lenses reduced refractive cylinder from 1 and 2.25 D preoperatively to 0 D in both eyes postoperatively.
• A comparison of biometry measurements taken before and after DMEK showed the median change in average keratometry was 0.26 D with a range of -1.74 to +1.18 D.
• The median endothelial cell loss was 63 cells/mm2
(3 percent) after staged phacoemulsification.
Scientists found that favorable visual and refractive outcomes were obtained with presbyopia-correcting IOLs in individuals with Fuchs’ dystrophy when the biometry measurements and IOL implantation were staged after DMEK had cleared the guttae and corneal edema.
SOURCE: Price MO, Pinkus D, Price FW Jr. Implantation of presbyopia-correcting intraocular lenses staged after Descemet membrane endothelial keratoplasty in patients with Fuchs dystrophy. Cornea 2019; Dec 12. [Epub ahead of print].
Topographic Analysis of Photoreceptor Loss Correlated with nAMD Disease Morphology
Researchers quantified morphologic photoreceptor integrity during anti-vascular endothelial growth factor therapy of neovascular age-related macular degeneration, and correlated these findings with disease morphology and function.
This post hoc analysis included spectral-domain optical coherence tomography data on 185 patients acquired at baseline, month three and month 12 in a multicenter, prospective trial. Researchers manually quantified loss of the ellipsoid zone (EZ) in all optical coherence tomography volumes. And they automatically segmented intraretinal cystoid fluid, subretinal fluid (SRF) and pigment epithelial detachments in the full volumes using validated deep learning methods. Further, they performed spatiotemporal correlation of fluid markers with EZ integrity as well as bivariate analysis between EZ integrity and best-corrected visual acuity. Here were some of the findings:
• At baseline, EZ integrity was predominantly impaired in the fovea, showing progressive recovery during anti-VEGF therapy.
• Topographic analysis at baseline revealed EZ integrity to be more likely intact in areas with SRF.
• A correlation was observed between EZ integrity and resolution of SRF.
• Foveal EZ integrity correlated with BCVA at all time points.
Researchers determined that improvement of EZ integrity during anti-VEGF therapy for nAMD occurred predominantly in the fovea and that photoreceptor integrity correlated with BCVA. They also reported that EZ integrity was preserved in areas of SRF and showed deterioration upon SRF resolution.
SOURCE: Riedl S, Cooney L, Grechenig C, et al. Topographic analysis of photoreceptor loss correlated with disease morphology in neovascular age-related macular degeneration. Retina 2019; Nov 13. [Epub ahead of print].
Natural History of GA Secondary to AMD: Proxima A and B Clinical Trials
Researchers aimed to better characterize visual function decline and geographic atrophy progression secondary to age-related macular degeneration, as part of the Proxima A and B global, prospective, non-interventional, observational clinical trials that were originally intended to support the approval of the now defunct lampalizumab program for dry AMD.
Eligible participants were ≥50 years of age. Those in Proxima A had bilateral GA without choroidal neovascularization in either eye (n=295). Those in Proxima B had GA with no CNV in the study eye and CNV ±GA in the fellow eye (fellow eye CNV cohort, n=168); or GA with no CNV in the study eye without CNV/GA in the fellow eye (fellow eye intermediate AMD cohort, n=32).
Researchers evaluated changes in visual function and imaging/anatomic parameters over time using a mixed model for repeated measurement accounting for key baseline characteristics.
Main outcome measures included pre-specified endpoints such as change in GA area from baseline, best-corrected visual acuity score assessed by ETDRS and BCVA under low-luminance conditions (LLVA). Here were some of the findings:
• At 24 months, the adjusted mean (standard error [SE]) change in GA lesion area from baseline was:
o 3.87 (0.15) mm2
in participants with bilateral GA (Proxima A);
o 3.55 (0.16) mm2
in the fellow eye CNV cohort (Proxima B); and
o 2.96 (0.25) mm2
in the fellow eye intermediate AMD cohort (Proxima B).
• GA progression was greater in individuals with baseline non-subfoveal (vs. subfoveal) GA lesions and tended to increase as baseline low-luminance deficit increased (all subjects).
• Fellow-eye conversion to GA occurred in 30 percent, and to CNV in 6.7 percent of participants in the Proxima B intermediate AMD cohort at month 12.
• Adjusted mean changes in spherical-equivalent BCVA and LLVA (ETDRS letters)
in the study eye from baseline to 24 months were, respectively:
o -13.88 (1.40) and -7.64 (1.20) in the Proxima A group;
o -9.49 (1.29) and -7.57 (1.26) in the Proxima B fellow eye CNV cohort; and
o -11.48 (3.39) and -8.37 (3.02) in the Proxima B fellow eye intermediate AMD cohort.
Researchers wrote that the prospective Proxima A and B studies highlighted the severe functional impact of GA and the rapid rate of GA lesion progression over a two-year period, including in individuals with unilateral GA at baseline.
Source: Holekamp N, Wykoff CC, Schmitz-Valckenberg SS, et al. Natural history of geographic atrophy secondary to age-related macular degeneration: Results from the prospective Proxima A and B clinical trials. Ophthalmology 2019; Dec 14. [Epub ahead of print].
B+L Initiates Trial Evaluating New Viscosurgical Device
Bausch + Lomb announced that it initiated a clinical trial evaluating the safety and efficacy of a new cohesive ophthalmic viscosurgical device intended to provide surgeons with a new option to aid in their surgeries. This is the second new OVD that the company is working to bring to the U.S. market, according to Bausch + Lomb. Read more.
FDA Committee Unanimously Supports Use of Teprotumumab
Horizon Therapeutics plc announced that the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted unanimously to support that the potential benefits of teprotumumab, a fully human monoclonal antibody, outweigh the potential risks when used for the treatment of thyroid eye disease. If approved, teprotumumab would be the first FDA-approved medicine for TED. An investigational medicine, teprotumumab’s safety and efficacy haven’t been established. The FDA is evaluating a Biologics License Application (BLA) for teprotumumab for the treatment of TED, with a Prescription Drug User Fee Act action date of March 8. The BLA submission is based on positive results from the Phase III confirmatory clinical trial OPTIC and positive Phase II results, which included findings that significantly more individuals treated with teprotumumab (82.9 percent) had a meaningful improvement in proptosis compared with placebo (9.5 percent). Read more.
Bausch Health Licenses Novaliq’s Nov03 Investigational Treatment
Bausch + Lomb and Novaliq announced that Bausch Health acquired an exclusive license for the commercialization and development in the United States and Canada of Novaliq’s investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat dry-eye disease associated with meibomian gland dysfunction. NOV03 is a proprietary, water-free, preservative-free solution based on Novaliq's patented EyeSol technology. In a Phase II study, NOV03 met its primary sign endpoint of improvement of total corneal fluorescein staining over control at eight weeks (p<0.001). A Phase III study is underway for NOV03, and Bausch Health anticipates starting an additional Phase III study in 2020. Read more.
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