Review of Ophthalmology Online



Vol. 22, #45  •   Monday, November 1, 2021





Topical Medication Adherence and VF Progression in OAG: Analysis of a Large U.S. Health-care System

To quantify the effect of nonadherence to topical hypotensive medication on glaucomatous visual field progression in clinical practice, researchers initiated a retrospective analysis of combined visual field and pharmacy data from Kaiser Permanente Southern California's HealthConnect electronic health record database.

Patients with a diagnosis of primary open-angle glaucoma or pseudoexfoliation glaucoma (2001 to 2011) and ≥3 subsequent visual field tests of the same Swedish Interactive Threshold Algorithm type were followed up from first medication fill to final visual field test. Medication adherence (proportion of days covered) was estimated from pharmacy refill data. A conditional growth model was used to estimate the effect of adherence level in modifying the progression of mean deviation over time after adjusting for potential confounders including age, sex, race/ethnicity, baseline glaucoma severity and comorbidity.

In total, 6,343 eligible patients were included in the study and followed for an average of 5.8 years; average treatment adherence during follow-up was 73 percent. After controlling for confounders and the interaction between time and baseline disease severity, the model indicated that mean deviation progression was significantly (p=0.006) reduced by 0.006 dB per year for each 10-percent absolute increase in adherence. Model estimates of time to glaucoma progression (mean deviation change -3 dB from baseline) were 8.3 years for patients with adherence levels of 20 percent and 9.3 years for patients with adherence levels of 80 percent.

Researchers wrote that improving patient adherence to topical glaucoma medication may result in slower deterioration in visual function over time.

SOURCE: Shu YH, Wu J, Luong T, et al. Topical medication adherence and visual field progression in open-angle glaucoma: Analysis of a large US healthcare system. J Glaucoma 2021; Oct 19. [Epub ahead of print].




Accuracy of Double-layer Sign in Detection of MNV Secondary to CSC

Investigators assessed the diagnostic value of elevated retinal pigment epithelium and double-layer sign (DLS) in identifying macular neovascularization secondary to central serous chorioretinopathy, as part of a retrospective, cross-sectional study.

Patients with CSCR underwent optical coherence tomography and OCT angiography at London’s Moorfields Eye Hospital. OCT scans were reviewed to identify the presence/absence of an RPE elevation. The maximum length/height of the elevated RPE were measured. A minimum length of 1,000 µm and a maximum height of 150 µm were used to define the “double-layer sign.” Other qualitative anatomical features were graded from OCT scans. OCTA was examined to confirm the presence/absence of MNV. Binary logistic regression analyses helped assess the association between OCT features and the detection of MNV on OCTA. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated to assess the diagnostic accuracy.

A total of 163 eyes from 132 patients were included. Here are some of the findings:
• Elevated RPE was detected in 148 eyes (91 percent).
• OCTA-confirmed MNV was detected in 54 eyes (33 percent).
• The sensitivity of RPE elevation was 100 percent, and specificity was 13.8 percent.
• DLS was identified in 95 eyes (58 percent).
• The sensitivity of DLS for detecting MNV was 87 percent, and specificity was 56 percent.
• Hyperreflectivity and non-homogeneity of the sub-RPE space were independently associated with MNV within the DLS (OR, 17.7 and 14.8, p<0.001 and p=0.02, respectively).
• None of the other demographic or anatomical features assessed were associated with MNV.
• The presence of non-homogeneous hyperreflective RPE elevation had a sensitivity of 98 percent and specificity of 67 percent, with PPV of 60 percent and NPV of 99 percent.

Investigators found that non-homogeneous and hyperreflective space under an elevated RPE of any length or height indicated an eye with higher risk of MNV than DLS. They suggested that OCTA should be performed for such eyes to confirm the presence of MNV and treat accordingly.

SOURCE: Hagag AM, Rasheed R, Chandra S, et al. The diagnostic accuracy of double-layer sign in detection of macular neovascularization secondary to central serous chorioretinopathy. Am J Ophthalmol 2021; Oct 23. [Epub ahead of print].




Grading System to Evaluate Punctate Epithelial Erosions Using Deep Neural Networks

Scientists developed a fully automated grading system for the evaluation of punctate epithelial erosions using deep neural networks. The system detected corneal position and graded staining severity given a corneal fluorescein staining image.

The fully automated pipeline consisted of three steps:
1. A corneal segmentation model extracted corneal area. Five image patches were cropped from the staining image based on the five subregions of extracted cornea.
2. A staining grading model predicted a score for each image patch from 0 to 3, and an automated grading score rated the whole cornea from 0 to 15.
3. The clinical grading scores annotated by three ophthalmologists were compared with automated grading scores.

Here are some of the findings:
• For corneal segmentation, the segmentation model achieved an intersection over union of 0.937.
• For punctate staining grading, the grading model achieved a classification accuracy of 76.5 percent and area under the ROC curve of 0.940 (CI, 0.932 to 0.949).
• For the fully automated pipeline, Pearson's correlation coefficient between the clinical and automated grading scores was 0.908 (p<0.01).
• Bland-Altman analysis revealed 95 percent limits of agreement between the clinical and automated grading scores of between -4.125 and 3.720 (concordance correlation coefficient=0.904).
• The average time required for processing a single stained image during the pipeline was 0.58 seconds.

Scientists reported the fully automated grading system to evaluate these erosions may serve as a reference for ophthalmologists in clinical trials and residency training procedures.

SOURCE: Qu JH, Qin XR, Li CD, et al. Fully automated grading system for the evaluation of punctate epithelial erosions using deep neural networks. Br J Ophthalmol 2021; Oct 20. [Epub ahead of print].


Complimentary CME Education Videos



Lapses in Care Among Patients Assigned to Ranibizumab for PDR

Researchers reported on the completion of scheduled exams among participants assigned to intravitreous injections of ranibizumab for PDR in a multicenter randomized clinical trial.

The post hoc analysis evaluated data from a randomized clinical trial conducted at 55 U.S. sites of 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012. Both eyes were enrolled for 89 participants (one eye to each study group) for a total of 394 study eyes. The final two-year visit was completed in January 2015. Data were analyzed from April 2019 to July 2021.

Interventions included ranibizumab injections for PDR or macular edema, and main outcomes and measures included a lapse in care of eight or more weeks past a scheduled exam, dropout from follow-up and visual acuity at five years.

Among 170 participants, the median age was 51 years; 44.7 percent were female. Here are some of the findings:
• Through five years of follow-up, 94 of 170 participants (55.3 percent) had one or more long lapses in care.
• The median time to the first long lapse was 210 weeks, and 69 of 94 participants (73.4 percent) returned for an exam after the first long lapse.
• Fifty of 170 participants (29.4 percent) dropped out of follow-up by five years.
• Among 120 participants who completed the five-year exam, median change from baseline in visual acuity was -2 letters for participants who had one or more long lapses compared with +5 letters for those without a long lapse (p=.02).
• After multivariable adjustment, the odds ratio for baseline associations with one or more long lapse was 1.21 (CI, 1.03 to 1.43) for each five-letter decrement in visual acuity score; 2.19 (CI, 1.09 to 4.38) for neovascularization of the disc and elsewhere; and 3.48 (CI, 1.38 to 8.78) for no prior laser treatment for diabetic macular edema.

Researchers found that, over five years, approximately half of participants assigned to ranibizumab for PDR had a long lapse in care despite substantial effort by the DRCR Retina Network to facilitate timely completion of exams. They recommended that the likelihood of a long lapse in care during long-term follow-up should be considered when choosing treatment for PDR.

SOURCE: Maguire MG, Liu D, Bressler SB, et al. Lapses in care among patients assigned to ranibizumab for proliferative diabetic retinopathy: A post hoc analysis of a randomized clinical trial. JAMA Ophthalmol 2021; Oct 21. [Epub ahead of print].




Industry News

FDA Approves Genentech’s Susvimo for Wet AMD

Genentech announced the FDA approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of individuals with wet age-related macular degeneration who have previously responded to at least two anti-vascular endothelial growth factor injections. Susvimo, previously called Port Delivery System with ranibizumab, offers as few as two treatments per year and delivers ranibizumab continuously, offering an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the implant is in place. Read more.

B+L & Clearside Get FDA nod for Xipere

Bausch + Lomb announced the FDA approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. The SCS Microinjector is designed to provide targeted and compartmentalized delivery, and higher absorption relative to intravitreal injection, the company says. Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment, potentially reducing risk of certain adverse events such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, says the drug’s maker. Read more.

Generation Bio DNA Delivery Data

Generation Bio presented new preclinical data demonstrating widespread delivery of multiple nucleic acid cargos to photoreceptors using the company’s cell-targeted lipid nanoparticle (ctLNP), at the European Society of Gene and Cell Therapy annual congress, held virtually. The company says that subretinal delivery of its proprietary closed-ended DNA (ceDNA) using ctLNP demonstrated broad photoreceptor distribution and durable expression in rodents, comparable to AAV5 delivery. Read more.

iCare Acquires Oculo

iCare USA’s parent company, Revenio, announced its acquisition of Oculo, an Australian telehealth company, remote patient monitoring and clinical communications. Oculo says its software platform enables doctors to communicate and exchange clinical correspondence such as patient referrals, clinical data and images, in a secure and HIPAA-compliant way. Oculo recently integrated telemedicine into its platform so clinicians can conduct secure video consultations. Learn more.


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