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| Vol. 22, #43 • Monday, October 18, 2021 |
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OCTOBER IS HALLOWEEN SAFETY MONTH
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Digital Gonioscopy Based on 3D AS-OCT
Researchers developed and evaluated the performance of a three-dimensional deep-learning-based automated digital gonioscopy system (3D-DGS) in detecting two major characteristics in eyes suspected to have primary angle-closure glaucoma: 1) narrow iridocorneal angles (static gonioscopy, Task I) and; 2) peripheral anterior synechiae (dynamic gonioscopy, Task II) on optical coherence tomography scans.
The international cross-sectional multicenter study included a total of 1.112 million images of 8,694 volume scans (2,294 patients) from three centers (Task I: training/internal validation/external testing related to 4,515, 1,101, 2,222 volume scans respectively; Task II: training/internal validation/external testing related to 378, 376, 102 volume scans respectively).
For Task I, a narrow angle was defined as an eye in which the posterior pigmented trabecular meshwork wasn’t visible in more than 180 degrees without indentation in the primary position captured in the dark room from the scans. For Task II, PAS was defined as the adhesion of the iris to the trabecular meshwork. The diagnostic performance of the 3D-DGS was evaluated in both tasks, with gonioscopic records as reference.
The area under curve (AUC), sensitivity and specificity of the 3D-DGS were calculated. Here are some of the findings:
• In Task I, 29.4 percent of patients had a narrow angle.
• The AUC, sensitivity and specificity of 3D-DGS on the external testing datasets were 0.943 (0.933 to 0.953), 0.867 (0.838 to 0.895) and 0.878 (0.859 to 0.896), respectively.
• For Task II, 13.8 percent of patients had PAS.
• The AUC, sensitivity and specificity of 3D-DGS were 0.902 (0.818 to 0.985), 0.900 (0.714 to 1.000) and 0.890 (0.841 to 0.938) on the external testing set at quarter level following normal clinical practice; and 0.885 (0.836 to 0.933), 0.912 (0.816 to 1.000) and 0.700 (0.660 to 0.741) on the external testing set, at clock-hour level.
Researchers found that the 3D-DGS method was effective in detecting eyes suspected to have PACG. They added that the technology has the potential to be used widely in the primary eye care community for screening of subjects at high risk of developing PACG.
SOURCE: Li F, Yang Y, Sun X, et al. Digital gonioscopy based on three-dimensional anterior segment optical coherence tomography: An international multicenter study. Ophthalmology 2021; Oct 4. [Epub ahead of print].
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Six-year Incidence of AMD & Correlation to OCT-derived Drusen Volume
Scientists reported the six-year incidence of optical coherence tomography-derived age-related changes in drusen volume and related systemic and ocular associations.
Chinese adults ages 40 years and older were assessed at baseline and six years with color fundus photography (CFP) and spectral-domain optical coherence tomography. CFPs were graded for AMD features, and drusen volume was generated using commercially available automated software.
A total of 4,172 eyes of 2,580 participants (mean age 58.12 ±9.03 years; 51.12 percent women) had baseline and six-year follow-up CFP for grading. Of these, 2,130 eyes of 1,305 participants had gradable SD-OCT images, available for analysis. Here are some of the findings:
• Based on CFP grading, 136 participants (3.39 percent) developed incident early AMD and 10 (0.25 percent) developed late AMD. Concurrently, retinal pigment epithelial-Bruch's membrane (RPE-BrC) volumes decreased, remained stable and increased in 6.8 percent, 78.5 percent and 14.7 percent, respectively, over six years.
• Having eyes with RPE-BrC volumes >0 mm3 at baseline was associated with two-fold higher prevalence rate of any AMD at baseline (p<0.001).
• Multivariable analysis showed that, in comparison to eyes in which RPE-BrC volume was unchanged, volume decrease was significantly associated with older age (OR=1.30; p<0.001), smoking (OR=2.21; p=0.001) and chronic kidney disease (OR=3.4, p=0.008), while increase was associated with older age (OR=1.36; p<0.001) and hypertension (OR=1.43; p=0.016).
Scientists concluded that AMD incidence detected at six years on CFP had a low correlation to OCT-derived drusen volume measurement change. They added that older age and some systemic risk factors were associated with drusen volume change, providing new insights into the relationship between systemic risk factors and outer retinal morphology in Asian eyes.
SOURCE: Tan AC, Chee ML, Fenner BJ, et al. Six-year incidence of age-related macular degeneration and correlation to OCT-derived drusen volume measurements in a Chinese population. Br J Ophthalmol 2021; Oct 4. [Epub ahead of print].
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Complimentary CME Education Videos
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EDOF vs. SV Contact Lens in Eyes with Monofocal IOLs
Investigators assessed the visual performance of extended depth of focus contact lenses in eyes that had undergone monofocal intraocular lens implantation, and compared that between EDOF and single-vision contact lenses, as part of a prospective, randomized crossover study.
Seventeen patients implanted with monofocal IOLs were enrolled. The study was conducted using 1dayPure EDOF as a test CL and 1dayPure moisture (both SEED lenses) as a control CL. Binocular visual acuity from far to near distances, photopic and mesopic contrast sensitivity (with and without glare), and stereopsis were evaluated after subjects wore the two kinds of CLs in random order.
Here are some of the findings:
• Binocular visual acuity at 0.3, 0.4, 0.7, 1, and 5 m was 0.24 ± 0.12, 0.07 ± 0.09, - 0.02 ±0.08, - 0.02 ±0.08, and - 0.06 ±0.07 logMAR during the EDF CL wear, respectively, and 0.39 ±0.17, 0.26 ±0.15, 0.04 ±0.12, - 0.02 ±0.08, and - 0.09 ±0.09 during the SV CL wear, respectively.
• The EDOF CL showed better results than the SV CL at 0.3, 0.4, and 0.7 m (p<0.05).
• No significant differences were found in contrast sensitivity between the EDOF and SV CLs at 1.5 cycles per degree under all conditions; however, the sensitivity of the EDOF CL was generally worse than that of the SV CLs from the middle to high spatial frequencies.
• Stereopsis at 40 cm was significantly better in the EDOF CL wear than in the SV CL wear (p<0.05).
Investigators reported that the EDOF CL substantially improved visual acuity at near to intermediate distances in IOL-implanted eyes. However, they added that far visual acuity decreased under low-contrast conditions, and contrast sensitivity slightly declined at the middle to high spatial frequencies.
(According to the study, the research was supported in part by an unrestricted investigator-initiated grant from Tokyo’s SEED contact lens company, but that the funders “had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”)
SOURCE: Hiraoka T, Kiuchi G, Hiraoka R, et al. Comparison of visual performance between extended depth of focus contact lens and single-vision contact lens in eyes with monofocal intraocular lens. Jpn J Ophthalmol 2021; Aug 5. [Epub ahead of print.]
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Outcomes of Patients with Submacular Hemorrhage Secondary to AMD in the IVAN Trial
Researchers compared demographics, visual acuity and retinal morphology between those with and without baseline submacular hemorrhage (SMH) for patients enrolled in the Inhibit VEGF in Age-related Choroidal Neovascularization trial (IVAN).
The secondary analyses of RCT image and clinical data included clinical trial data collected in 23 UK hospitals of IVAN study eyes (with untreated neovascular age-related macular degeneration (at randomization) with at least 12 months’ follow-up and adequate imaging.
Study eyes were randomly assigned to monthly ranibizumab, as-needed ranibizumab, monthly bevacizumab or as-needed bevacizumab. Imaging at baseline graded independently for presence, type, position and extent of SMH.
Main outcome measures included visual acuity (primary outcome), subretinal fibrosis, atrophic scarring, and retinal thickness outcomes at 12 and 24 months.
A total of 535 of 605 IVAN trial participants were included. Here are some of the findings:
• Patients with SMH at baseline (286, 53 percent) were older (p=0.010), and affected eyes were more likely to have intraretinal fluid present (p=0.038).
• VA was significantly worse in those with baseline SMH at month zero (p<0.001; estimate of difference: six letters with 95 percent confidence intervals of four to eight letters), but the difference decreased and wasn’t significant at month 12 or 24.
• No significant association was found between baseline SMH and subretinal fibrosis, atrophic scarring or central retinal thickness.
Researchers determined that presence of SMH at baseline was associated with age, intraretinal fluid and reduced baseline VA, although VA was no longer significantly different by month 12.
SOURCE: Mehta A, Steel DH, Muldrew A, et al. Associations and outcomes of patients with submacular haemorrhage secondary to age-related macular degeneration in the IVAN trial. Am J Ophthalmol 2021; Oct 5. [Epub ahead of print].
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Industry News
Outlook’s NORSE THREE Safety Data Presented at ASRS
Outlook presented results from its NORSE THREE supplemental safety study evaluating ONS-5010 / Lytenava (bevacizumab-vikg) at the 39th Annual Meeting of the American Society of Retina Specialists in San Antonio (October 8 to 12). The company says that data from NORSE THREE indicated that ONS-5010 showed no intraocular inflammation or vasculitis, and the frequency and incidence of adverse events and ocular adverse events were low. The most common adverse event in the study eye was conjunctival hemorrhage related to injection procedure, not to ONS-5010, and no additional serious adverse events associated with these injections were reported. Read more.
Novartis Files Applications for New Beovu Indication
Novartis recently announced that the US Food and Drug Administration has accepted the company’s supplemental Biologics License Application (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation application for Beovu (brolucizumab) 6 mg for the treatment of diabetic macular edema. Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu for use in the treatment of DME. Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe.
Learn more.
PALADIN Reveals Iluvien’s Ability to Reduce Treatment Burden in DME
Alimera Sciences says data presented at the American Society of Retina Specialists demonstrates significant reductions in treatment burden in patients receiving Iluvien for diabetic macular edema. The real-world data from the Phase IV PALADIN study showed that patients receiving one or less total anti-VEGF injections per year for their DME after the Iluvien injection increased three-fold from prior to the Iluvien injection. The data also showed that the percent of patients who needed more than four anti-VEGF DME treatments per year was reduced by half. Learn more.
RegenxBio Presents Data from Phase II Trial of RGX-314
RegenxBio announced initial data from the ongoing Phase II ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy without center-involved diabetic macular edema using in-office suprachoroidal delivery. As of September 29, the company says RGX-314 was reported to be well-tolerated in the 15 patients dosed with RGX-314 in cohort 1. The data was presented at the American Society of Retina Specialists annual meeting. Read more.
EyePoint Presents Preliminary Safety Data from Phase I DAVIO Trial and Yutiq CALM Registry Study
EyePoint Pharmaceuticals announced interim safety data from its Phase I clinical trial of EYP-1901, a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration. The company says that preliminary three-month safety data for all patients from its ongoing DAVIO trial of EYP-1901 continues to demonstrate an excellent safety profile with no serious ocular or systemic adverse events reported to date.
The company also recently shared preliminary results from Yutiq CALM, a real-world registry study of the fluocinolone acetonide intravitreal implant 0.18 mg in chronic noninfectious posterior uveitis. The two studies were presented at the American Society of Retina Specialists annual meeting. Read more.
GenSight Announces FDA Grants Fast Track Designation to RP Treatment
GenSight Biologics announced that the FDA granted Fast Track Designation to GS030, which combines AAV2-based gene therapy with optogenetics to treat Retinitis Pigmentosa. PIONEER, a Phase I/II first-in-human, multicenter, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of GS030 in subjects with late-stage RP, is being conducted in three centers across the United States, United Kingdom and France. Read more.
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