From the editors of Review of Ophthalmology:
OCTOBER IS HALLOWEEN SAFETY MONTH
In this issue: (click heading to view article)
Analysis of Macular Atrophy in HARBOR
Researchers have performed a post hoc analysis of patients from the HARBOR trial, a Phase III, multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial that compared ranibizumab administered monthly versus on an as-needed basis. Previous studies of macular atrophy in the HARBOR trial population analyzed color fundus photography and fluorescein angiography image data. The current study was based on a longitudinal assessment of monthly spectral-domain optical coherence tomography scans to determine the prevalence, incidence and progression of MA in HARBOR.
Participants included individuals (n=1,097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (treated with intravitreal ranibizumab 0.5 mg monthly (n=275); 0.5 mg pro re nata after three loading doses (PRN; n=275); 2 mg monthly (n=274); or 2 mg PRN (n=273).
In the report, masked, reading center-trained graders examined evaluable SD-OCT macular cube scans from individuals with 24 months’ follow-up (n=941) monthly from baseline to month 24. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid; retinal pigment epithelium loss; and loss of outer retinal layers. MA was considered “definite” if all three criteria were met and “questionable” if two criteria were met. Study arms were compared for time to MA detection (log-rank test) and enlargement rates (time arm interaction test).
Main outcome measures included prevalence, incidence and enlargement rates of MA. Here were some of the findings:
• At baseline, an imbalance was found in MA rates across ranibizumab arms (0.5 mg monthly, 19.1 percent; 0.5 mg PRN, 16.1 percent; 2 mg monthly, 10.1 percent; 2 mg PRN, 10.5 percent).
• At month 24, new MA development rates in eyes without baseline MA were similar between ranibizumab doses (0.5 mg, 25.9 percent; 2 mg, 25.4 percent) and treatment regimens (monthly, 26.4 percent; PRN, 25 percent).
• No significant differences were found in enlargement rates of new atrophy area (square-root transformed, p=
0.479) or time to detection of new MA (p=
0.997) among study arms.
In this first analysis of a major nAMD trial using the CAM atrophy criteria, researchers report that monthly vs. PRN treatment didn’t influence the incidence or progression of MA.
SOURCE: Gune S, Abdelfattah NS, Karamat A, et al. SD-OCT-based prevalence and progression of macular atrophy in the HARBOR study for neovascular age-related macular degeneration. Ophthalmology 2019; Sep 27. [Epub ahead of print].
Perimetry in Glaucoma Patients with Mild Visual Loss
Investigators wrote that the peripheral visual field in glaucoma outside 30 degrees is largely unexplored with static perimetry. They aimed to use threshold static automated perimetry to characterize visual loss in glaucoma of the central 30 degrees and far periphery.
Investigators administered their 30-2 perimetric test to 27 early-stage (mean deviation better than -4 dB) glaucoma patients with the Goldmann III and V stimulus sizes, and a custom test from 30 degrees to up to 87 degrees with the size V stimulus, twice within a month. They quantified: the retest variability; proportion of patients flagged as abnormal (at level 0.05) based on pointwise probability distributions obtained from 63 ocular healthy observers; pointwise statistical distance using the Kullback-Leibler divergence between normal and glaucoma eyes; and the effect of eccentricity on visual loss. Here were some of the findings:
• Size V 30-2 testing identified significantly more abnormal test locations (36 percent) than size III 30-2 (30 percent; p=0.004).
• Kullback-Leibler divergence between healthy and glaucoma distributions was greatest for the nasal mid-peripheral test locations and the inferior temporal sector area.
• Investigators found a more pronounced decrease in visual sensitivity with eccentricity in glaucoma patients compared with healthy participants across the full visual field (p<0.001).
Investigators reported that glaucoma patients demonstrated a systematic decrease in sensitivity with eccentricity across the full visual field, and that Goldmann size V stimuli better detected visual loss in glaucoma patients with mild loss than size III.
SOURCE: Wall M, Lee EJ, Wanzek RJ, et al. Threshold automated perimetry of the full visual field in glaucoma patients with mild visual loss. J Glaucoma 2019; Sep 25. [Epub ahead of print].
Intraoperative OCT-assisted DMEK in DISCOVER: First 100 Cases
Scientists wrote that intraoperative optical coherence tomography may facilitate successful transition to Descemet’s membrane endothelial keratoplasty surgery via improved efficiency of tissue orientation. The purpose of this study was to report a large consecutive series of iOCT-assisted DMEK, inclusive of all learning curve cases. Two of the study authors have a license agreement with Bioptigen for an external mount system related to intraoperative OCT and a license option agreement with Synergetics related to the development OCT compatible surgical instruments.
The prospective, consecutive case series used the DISCOVER study, a single-site, multi-surgeon, IRB-approved investigational device prospective study for a review. Scientists reviewed the first 100 consecutive iOCT-assisted DMEK surgeries performed by one attending corneal surgeon (JMG) and six novice surgeons (cornea fellows under supervision). iOCT was used for tissue orientation. Scientists reported on patient demographics, tissue characteristics, intraoperative parameters and postoperative complications.
A total of 100 eyes of 76 individuals were enrolled. Forty-three cases were performed by one staff physician, and 57 cases were performed by six cornea fellows. Concurrent phacoemulsifcation with lens implantation was performed in 52 cases (52 percent).
Here were some of the findings:
• Nine eyes (9 percent) required rebubbling.
• Two eyes (2 percent) experienced primary graft failure.
• One graft failure resulted from surgeon error in interpreting the iOCT.
• Average unscrolling time was 4.4 ±4.1 minutes (range: 0.7 to 27.6 minutes).
iOCT facilitated DMEK orientation without the need for external markings. For novice DMEK surgeons, complication rates and unscrolling times compared favorably with alternative tissue orientation methods.
SOURCE: Patel AS, Goshe JM, Srivastava SK, et al. Intraoperative optical coherence tomography-assisted Descemet membrane endothelial keratoplasty in the DISCOVER study: First 100 Cases. Am J Ophthalmol 2019; Sep 25. [Epub ahead of print].
Neuron-specific Enolase, S100B and Malondialdehyde Levels in Serum & Vitreous of PDR Patients
Researchers assessed the vitreous and serum levels of neuron-specific enolase (NSE), S100B and malondialdehyde (MDA) in proliferative diabetic retinopathy cases, and investigated the correlation between preoperative and postoperative anatomical and clinical features.
The study group included individuals who had pars plana vitrectomy for PDR. The control group included non-diabetic individuals who underwent PPV surgery for vitreoretinal interface disorders. Researchers took samples of serum from all participants preoperatively, and took vitreous samples during the PPV. They measured vitreous and serum levels of NSE, S100B and MDA, and made comparisons between the groups.
The study group consisted of 56 eyes of 56 cases with PDR. The control group consisted of 20 eyes of 20 cases. Concentrations in the markers were significantly higher than in the control group in vitreous NSE (p<
0.0001), S100B (p<
0.05) and MDA (p<
0.001). Serum levels were statistically different for NSE and S100B (p<
Researchers wrote that the vitreous levels of S100B, NSE and MDA, and serum concentrations of NSE and S100B, increased significantly in individuals with PDR. They added that their findings may indicate neurodegeneration and oxidative stress such that the markers could have a diagnostic value in patients with PDR.
Source: Asadova V, Gul Z, Buyukuysal RL, et al. Assessment of neuron-specific enolase, S100B and malondialdehyde levels in serum and vitreous of patients with proliferative diabetic retinopathy. Int Ophthalmol 2019; Sep 30. [Epub ahead of print].
Product-specific J-Code For Omeros’ Omidria in Effect
Omeros Corporation announced that the product-specific J-code for Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is now effective. The drug is intended for use during cataract surgery to prevent miosis and reduce postoperative pain. The new permanent J-code for OMIDRIA, J1097, replaces the previous temporary C-code C9447. Learn more.
B+L Enters Licensing Agreement With Tatvum Research
Bausch + Lomb entered into a licensing agreement with Tatvum Research that provides B+L with worldwide commercial rights to new IOL designs for enVista IOLs that will address astigmatism and presbyopia. When available, the new IOLs, developed in partnership by the two companies, will include a series of lenses that will correct for astigmatism and presbyopia, and feature an enhanced range of vision. Bausch + Lomb anticipates filing for regulatory approval of the lenses over the next several years. Read more.
J&J Vision Care Introduces New Disinfecting Solution
Johnson & Johnson Vision launched the Acuvue RevitaLens Multi-Purpose Disinfecting Solution (MPDS), which the company says is designed to deliver exceptional disinfection and all-day comfort for reusable contact lens wearers. Its dual-disinfecting formula is intended to be “gentle on the eyes but tough on germs and bacteria,” J&J Vision says. Read more.
Second Sight Announces $2.4 Million NIH Grant
Second Sight Medical Products announced receipt of a $2.4 million, four-year grant from the National Institutes of Health to develop spatial localization and mapping technology (SLAM). A joint collaboration with the Johns Hopkins University Applied Physics Laboratory, the initiative is intended to speed the integration of SLAM into next-generation versions of the Orion Visual Cortical Prosthesis System, the company says. Read more.
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