Review of Ophthalmology Online



Vol. 22, #14  •   Monday, April 5, 2021


In this Issue:


PACG and POAG Progression by OCT

Researchers compared the role of spectral-domain optical coherence tomography in regard to retinal nerve fiber layer and ganglion cell complex (GCC) assessment in the detection of primary angle-closure glaucoma and primary open-angle glaucoma progression.

In the prospective study, researchers examined 131 subjects with PACG and POAG over 72 months, with follow-up visits every six months. They detected visual field progression using the Guided Progression Analysis of the Humphrey visual field analyzer, and structural change using SD-OCT, while evaluating a significant negative trend for RNFL and GCC thicknesses. The diagnostic accuracy of RNFL and GCC thinning in the detection of glaucoma progression was compared between PACG and POAG eyes using the Kaplan-Meier method with the calculation of the log-rank test.

Here are some of the findings:
• Progression was detected in 57 percent of eyes with POAG and 59 percent of eyes with PACG.
• The rate of thinning of RNFL (-2.95 ±1.85 μm/y) and GCC (-3.22 ±2.96 μm/y) was significantly higher in PACG eyes (-1.64 ±2 μm/y; p=0.018) vs. POAG eyes (-1.74 ±2.05 μm/y)(p=0.046).
• Progression was associated with initial pattern standard deviation (PSD) in both glaucoma subtypes; however, PACG reflected long-term IOP fluctuations (cutoff >5.2 mmHg) and lens thickness changes (cutoff >4.92 mm); while POAG saw initial focal loss volume of GCC (cutoff >1.5 percent).
• In PACG, the rate of visual function deterioration correlated with the GCC thinning rate (r=0.330, p=0.027), but not with the RNFL thinning rate (r=-0.010, p=0.79); in POAG, the rate of visual function deterioration was significant for both RNFL thinning (r=0.296, p=0.039) and GCC thinning (r=0.359, p=0.011).
• In PACG patients with progressive GCC thinning, functional progression was detected earlier (log-rank test, p≤0.001) than in patients with progressive RNFL thinning (log-rank test, p=0.457); in POAG patients, the results were p=0.012 for GCC thinning and p≤0.001 for RNFL thinning.

Researchers concluded that SD-OCT played an important role in detecting PACG progression, and GCC thinning predicted functional loss better than the RNFL thinning, though this wasn’t the case in POAG.

SOURCE: Kurysheva NI, Lepeshkina LV. Detection of primary angle closure glaucoma progression by optical coherence tomography. J Glaucoma 2021; Mar 5. [Epub ahead of print].




IAI vs. Sham as Prophylaxis Against Conversion to Exudative AMD in High-risk Eyes

Anti-vascular endothelial growth factor agents may provide a prophylactic effect in high-risk eyes with intermediate dry age-related macular degeneration against conversion to exudative AMD (eAMD), lowering the risk of vision loss. Investigators evaluated intravitreal aflibercept injection as prophylaxis against the conversion to eAMD in high-risk eyes at 24 months.

This single-masked, sham-controlled, randomized clinical trial performed at four U.S. clinical sites enrolled patients with intermediate AMD in one eye (study eye), defined as: presence of more than 10 medium drusen (≥63 to <125 μm); at least one large druse (≥125 μm) and/or retinal pigmentary changes; and eAMD in the fellow eye. Patients were treated from June 23, 2015 to March 13, 2019.

Patients received intravitreal aflibercept injection (2 mg) or sham quarterly injection for 24 months (1:1 randomization). The primary endpoint was the proportion of patients with conversion to eAMD at month 24 characterized by development of choroidal neovascularization, as assessed by leakage on fluorescein angiography and fluid on spectral-domain optical coherence tomography by an independent masked reading center.

Of 128 patients enrolled, 127 (63 in the IAI group and 64 in the sham group) were included in the primary analysis (68 men [53.5 percent]; mean age, 76.5 ±8.1 years). Baseline demographic and clinical characteristics were balanced between the groups. Here are some of the findings:
• By month 24, six patients (9.5 percent) in the IAI group and seven (10.9 percent) in the sham group developed eAMD (p=0.98).
• Patients with a history of eAMD for longer than two years in their fellow eye at baseline showed a lower rate of conversion to eAMD in the study eye compared with those with a history of eAMD for two years or less in the fellow eye.
• Safety was consistent with previous studies involving intravitreal anti-VEGF injections.

Investigators found that the rates of conversion weren’t lower in the IAI group compared with the sham-treatment group at month 24. They added that understanding the mechanism of conversion to eAMD and therapies that could prevent this event remain an important unmet need.

SOURCE: Heier JS, Brown DM, Shah SP, et al. Intravitreal aflibercept injection vs sham as prophylaxis against conversion to exudative age-related macular degeneration in high-risk eyes: a randomized clinical trial. JAMA Ophthalmol 2021; Mar 18. [Epub ahead of print].



Corneal Thickness and Opacity Depth Assessed by OCT and UBM

Scientists compared the measurements of central thickness and depth of involvement of opacity-bearing corneas at different intensities (mild, moderate and dense) using different instruments: Visante and Optovue optical coherence tomography; ultrasound biomicroscopy (UBM); and ultrasound pachymetry (central thickness).

In a sample of 102 eyes, 70 eyes (68.63 percent) had some corneal opacity, and 32 eyes (31.37 percent) had normal corneas. Corneal opacity grading included: mild (28 eyes, 40 percent); moderate (27 eyes, 37.57 percent); and dense (15 eyes, 21.43 percent). Opacity intensity was graded and documented. Central corneal thickness, ultrasound pachymetry, UBM VuMax (50 MHz) and depth of corneal opacity were determined using using Optovue and Visante OCTs and UBM.

Here are some of the findings:
• Total corneal thickness of the control group showed differences with a small correction factor using: Optovue OCT (534.03 ±39.88 μm); Visante OCT (523.72±38.70 μm): and ultrasound pachymetry (529.84 ± 39.76 μm); and were higher when compared to UBM (492.06 ± 37.93 μm).
• In mild opacity, depth measurements were the same with OCT Optovue and Visante, and higher than those by UBM.
• In moderate opacities, no differences in measurements were found by different instruments.
• In dense opacities, OCT Optovue and Visante measurements were the same and/or higher than those by UBM.

Scientists reported that central corneal thickness measurements were reportedly higher in corneas with opacity vs. normal corneas, with the greatest thicknesses in corneas with dense opacities. In addition, scientists found a difference between measurements taken by different instruments relative to central thickness and opacity depth in cases of mild and dense opacity, but no difference in cases of moderate opacity.

SOURCE: Garcia PN, Chamon W, Allemann N. Comparability of corneal thickness and opacity depth assessed by OCT and UBM. Graefes Arch Clin Exp Ophthalmol 2021; Mar 25. [Epub ahead of print].



OCT Signs of Early Atrophy in AMD: Inter-reader Agreement

Researchers analyzed inter-reader agreement for incomplete and complete retinal pigment epithelium and outer retinal atrophy (iRORA and cRORA, respectively), and related features in age-related macular degeneration, as part of an inter-reader agreement study.

After 12 readers from six reading centers received formal training, they qualitatively assessed 60 optical coherence tomography B-scans from 60 eyes with AMD for nine individual features associated with early atrophy. They performed seven different annotations to quantify the spatial extent of OCT features within regions-of-interest. Qualitative and quantitative features were used to derive the presence of iRORA and cRORA as part of an exploratory analysis to examine if agreement could be improved using different combinations of features to define OCT atrophy.

Main outcome measures included inter-reader agreement based on Gwet’s first-order agreement coefficient (AC1) for qualitatively graded OCT features and classification of iRORA and cRORA, and smallest real difference (SRD) for quantitatively graded OCT features.

Here were some of the findings:
• Substantial or better inter-reader agreement was observed for all qualitatively graded OCT features associated with atrophy (AC1=0.63 to 0.87), except for retinal pigment epithelium attenuation (AC1=0.46) and disruption (AC1=0.26).
• The lowest SRD for the quantitatively graded horizontal features was observed for the zone of choroidal hypertransmission (±190.8μm).
• Moderate agreement was found for a three-category classification of no atrophy, iRORA and cRORA (AC1=0.53).
• Exploratory analyses suggested a significantly higher level of agreement for a three-category classification using: no atrophy; presence of inner nuclear layer and outer plexiform layer subsidence, or a hyporeflective wedge-shaped band as a less severe atrophic grade; and the latter plus an additional requirement of choroidal hypertransmission ≥250μm for a more severe atrophic grade (AC1=0.68; p=0.013).

Researchers reported that assessment of iRORA and cRORA, and most of their associated features, were able to be performed relatively consistently and robustly. They added that a refined combination of features to define early atrophy could further improve inter-reader agreement.

SOURCE: Wu Z, Pfau M Blodi BA, et al. Optical coherence tomography signs of early atrophy in age-related macular degeneration: Inter-reader agreement. CAM Report 6. Ophthalmol Retina 2021; Mar 22. [Epub ahead of print.]




Industry News

Outlook Therapeutics Reports Safety Data from NORSE THREE

Outlook Therapeutics announced topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / Lytenava (bevacizumab-vikg) to treat retinal diseases. Topline results from the open-label safety study demonstrated that ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior published data on the use of bevacizumab for ophthalmic conditions, the company says. Read more.


US Ophthalmic Offers EFC-2600 Non-mydriatic Digital Fundus Camera

US Ophthalmic says its new Ezer EFC-2600 non-mydriatic fundus camera and operating platform is a fully automated camera that can capture high-definition, 12 megapixel images of the retina. When choosing up to 10 fixation targets, the automatic mosaic modality function combines several image fields to produce a wide field-of-view of the retina (up to 100 degrees). In addition, the EFC-2600 can take images of the cornea, iris and lens. Learn more.



Luneau Upgrades Visionix Eye Refract

Luneau Technology introduced its second-generation Visionix Eye Refract, a compact eye refraction system that includes: an automated, binocular digital phoropter combined with wavefront-based auto-refractometry and keratometry (AR/K); a digital acuity short chart; and an integrated lens analyzer. Luneau says that clinicians can now use keratometry data collected from the Eye Refract system to fit soft contact lenses, and the “physiological refraction” feature can help quickly identify a patient’s comfort zone. Learn more.



Surface Ophthalmics Appoints Dr. Gupta as Chief Medical Advisor

Surface Ophthalmics appointed of Preeya K. Gupta, MD, as chief medical advisor. Dr. Gupta is a tenured associate professor of ophthalmology at Duke University Eye Center in Durham, N.C. Read more.

AdaptDx Pro's Onboard AI Technician Now Speaks in Multiple Languages

MacuLogix announced a software upgrade for its AdaptDx Pro portable dark adaptometer. The upgrade allows the artificial-intelligence-driven onboard technician, Theia, to provide patient instructions and user interfaces in multiple languages. Read more.



Complimentary CME Education Videos




Oasis to Launch My Oasis Cyber Platform at SECO 2021

Oasis Medical is formally launching its new patented cyber platform, My Oasis, at SECO International 2021, booth #722. The company says the platform is designed to help eye-care providers build their brand as a dry-eye resource, expand the reach of their practices, and give access to solutions that can improve the quality of life for dry-eye sufferers. Learn more.





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