From the editors of Review of Ophthalmology:
Monday, December 10, 2018
DECEMBER IS SAFE TOYS AND CELEBRATIONS MONTH
In this issue: (click heading to view article)
Macular Structure & Function Associations in AMD Treated With Intravitreal Ranibizumab
Researchers studied the correlation between optical coherence tomographic findings and focal macular electroretinograms at 12 months after intravitreal injections of ranibizumab in eyes with age-related macular degeneration, as part of a prospective clinical study.
They evaluated 28 eyes of 28 individuals with AMD treated with ranibizumab at monthly intervals for three months. Additional injections were given per a pro re nata regimen. OCT and fmERGs were performed preoperatively, and at three and 12 months postoperatively. The fmERGs were elicited by a 15-degree white stimulus spot centered on the fovea. The thickness of the inner, middle and outer layers of the retina, and of the serous retinal detachment and pigment epithelial detachment in the horizontal and vertical meridians at 1.2 mm from the fovea were measured.
• The b-wave amplitude at 12 months was significantly correlated with the thicknesses of the outer retinal layer, SRD and PED (p=0.001 to 0.02).
• Multiple regression analyses showed that the outer retinal layer thickness was an independent determinant (p=0.0001).
• Changes in the b-wave amplitude between baseline and 12 months were significantly correlated with changes in the SRD thickness (p=0.006).
• The changes in the b-wave amplitude during the PRN period were significantly correlated with changes in the PED thickness (p=0.02).
Researchers found that the reduction in SRD thickness affected macular function recovery 12 months after treatment initiation. They wrote that, as recurrences of the PED could occur during the PRN period, control of the PED would be necessary to obtain good macular function for the long term.
SOURCE: Nishimura T, Machida S, et al. Correlation between macular structure and function in patients with age-related macular degeneration treated with intravitreal ranibizumab: 12-month-results. Jpn J Ophthalmol 2018; Nov 23. [Epub ahead of print].
Tear-film Stability & Corneal Surface Regularity After SMILE
Investigators assessed dry eye after small incision lenticule extraction, and explored correlations between changes in tear-film stability, tear secretion and corneal surface regularity.
Sixty-two eyes of 22 men and 13 women who underwent SMILE were included. Investigators measured corneal topography to evaluate the index of surface variance and the index of vertical asymmetry. Dry-eye tests including subjective symptom questionnaires, tear breakup time, corneal fluorescein staining and Schirmer’s tests were evaluated before, and at one and six months postoperatively. Investigators found the following:
• TBUT significantly decreased from 9.8 ±3.4 seconds preoperatively, to 7.4 ± 3.8 seconds at one month and 6.5 ±3.6 seconds at six months (both p<0.001).
• Schirmer’s test results significantly decreased at one month postoperatively (p=0.012); however, the measurements returned to baseline by six months (p=0.522).
• The index of surface variance and index of vertical asymmetry significantly increased after surgery (all p<0.001).
• TBUT changes were negatively correlated with increases in index of surface variance asymmetry (r=-0.343; p=0.006) and index of vertical and r=-0.311; p=0.014).
Investigators concluded that individuals undergoing SMILE might develop a short-TBUT type of dry eye and that corneal surface regularity indices might help assess tear-film stability following SMILE procedures.
Source: Zhang H, Wang Y. Dry eye evaluation and correlation analysis between tear film stability and corneal surface regularity after small incision lenticule extraction. Int Ophthalmol 2018;38:6:2283-8.
Influence of Posterior PSC on Structural OCT & OCTA VD Measurements in Peripapillary Retina
A researcher analyzed the influence of posterior subcapsular cataracts on structural optical coherence tomography and OCT angiography vessel density measurements. The author is an unpaid consultant to Optovue, maker of the devices used in the study.
One eye each of 10 consecutive subjects with PSC were imaged using the AngioVue/RTVue-XR OCT via undilated pupil; and dilated pupil, 30 minutes later. Scientists compared peripapillary retinal nerve fiber layer thickness, peripapillary capillaries and all-vessels VD, ganglion cell complex thickness, parafoveal VD and image quality scores.
• PSC grade (mean ±SD) was 4 ±0.9, and best-corrected visual acuity was 0.8 ±0.2.
• Baseline median signal strength indices were: RNFLT, 66; and GCC, 67.5.
• Image quality scores were: peripapillary VD, 7.5; and parafoveal VD, 6; they didn’t change statistically and were clinically significant for pupil dilation (p≥0.0872).
• The mean RNFLT value increased by 1 μm, and mean GCC value increased by 1.1 μm (p≥0.1382; approximately 1 percent of normal values).
• The mean peripapillary all-vessels VD value increased by 1.2 percent (p=0.0349), and the mean peripapillary capillaries VD value increased by 1.1 percent (p=0.0599; approximately 2 to 2.5 percent of normal values for both parameters).
• No change in parafoveal VD was seen (0.2 percent; p=0.8209).
Scientists wrote that PSC-related peripapillary VD reductions might falsely suggest glaucoma progression, even when RNFLT wasn’t influenced by PSC. They added that glaucoma eyes with developing PSC needed pupil dilation for peripapillary VD measurements to reduce PSC-related VD reduction.
SOURCE: Holló G. Influence of posterior subcapsular cataract on structural OCT and OCT angiography vessel density measurements in the peripapillary retina. J Glaucoma 2018; Nov. 30. [Epub ahead of print].
Subretinal Fluid in nAMD Treated With Ranibizumab: FLUID Study
Researchers in the Novartis-sponsored FLUID study evaluated whether individuals with neovascular age-related macular degeneration who tolerated some subretinal fluid in treatment with ranibizumab using a treat-and-extend regimen could achieve similar visual acuity outcomes as treatment aimed at resolving all their SRF.
The multicenter, randomized, 24-month, Phase IV, single-masked, noninferiority clinical trial included subjects presenting with treatment-naive nAMD. Subjects with active subfoveal choroidal neovascularization were randomized to receive ranibizumab 0.5 mg monthly until complete resolution of SRF and intraretinal fluid (intensive arm: SRF intolerant) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 μm at the foveal center) before extending treatment intervals. A five-letter noninferiority margin was applied to the primary outcome measure. Main outcome measures included mean changes in best-corrected visual acuity and central subfield thickness, and number of ranibizumab injections from baseline to month 24.
Of 349 subjects randomized, 279 (79.9 percent) completed the month-24 visit. The mean (SD) change in BCVA from baseline to month 24 was three (16.3) letters in the intensive group and 2.6 (16.3) letters in the relaxed group, demonstrating noninferiority of the relaxed treatment to the intensive treatment (p=0.99). Similar proportions of the intensive (53.5 percent) and relaxed (56.6 percent) groups achieved ≥20/40 VA; p=0.92 and ≤20/200 VA (intensive: 8.7 percent; and relaxed; 8.1 percent; p=0.52).
• Results were supported by the per-protocol analysis and adjustment for confounding baseline factors.
• Subjects in the relaxed group received fewer ranibizumab injections over 24 months (mean [SD]; 15.8 [5.9]) than those in the intensive group (17 [6.5]; p=0.001).
• Significantly more subjects in the intensive group never extended beyond four-week treatment intervals (13.5 percent) than in the relaxed group (2.8 percent; p=0.003).
• Significantly more subjects in the relaxed group extended to and maintained 12 weekly treatment intervals (29.6 percent) than the intensive group (15 percent; p=0.005).
Researchers determined that individuals treated with a ranibizumab T&E protocol that tolerated some SRF achieved comparable VA (with fewer injections) to that achieved when treatment aimed to completely resolve all SRF.
SOURCE: Guymer RH, Markey CM, McAllister IL, et al. Tolerating subretinal fluid in neovascular age-related macular degeneration treated with ranibizumab using a treat and extend regimen: FLUID study 24 month results. Ophthalmology 2018; Nov 28. [Epub ahead of print].
Ocular Therapeutix’s Dextenza Approved
Ocular Therapeutix received FDA clearance for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery; it’s the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. The approval was based on: demonstrated efficacy in two randomized, vehicle-controlled Phase III studies in which a statistically significantly higher incidence of subjects were pain free at day eight post-cataract surgery compared with vehicle controls; safety in the two studies; and positive results in as randomized, vehicle-controlled Phase II study. Read more.
Prevent Blindness Establishes Center for Vision and Population Health
Prevent Blindness,a volunteer eye health and safety organization, has established the Center for Vision and Population Health as a national coordinating body for effective practices, state-level technical assistance and program interventions. The CVPH will work through diverse professional stakeholders and patient advocacy groups to drive improvements in policies and programs, and promote a coordinated national approach to eye health. A 2016 report from the National Academies of Sciences, Engineering and Medicine titled “Making Eye Health a Population Health Imperative: Vision for Tomorrow,” advanced a number of recommendations for improving eye health in the United States. One of the suggestions was the need for a coordinated national effort that engages key stakeholders to advance vision and eye health from a population health perspective, which Prevent Blindness hopes to achieve with the CVPH. Learn more.
ProQR Gets FDA Nod to Start Trial of QR-421a in Usher Syndrome Type 2
The FDA cleared ProQR Therapeutics’ Investigational New Drug application for QR-421a, a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of vision loss associated with Usher syndrome type 2 and non-syndromic retinitis pigmentosa due to mutations in exon 13 of the USH2A gene. ProQR plans to start enrolling patients in a Phase I/II trial, STELLAR, with preliminary data expected in mid-2019. Read more.
FDA Grants Notal Vision Device Breakthrough Device Designation
Notal Vision announced the FDA designated the Notal Vision home-based optical coherence tomography system as a “Breakthrough Device.” This designation indicates that FDA intends to provide interactive and timely communication with the sponsor, Notal, during device development and throughout the device’s review process for various types of premarket submissions on its quest for approval. The lightweight device is designed for operation by age-related macular degeneration patients from home. Once a patient completes the test, a proprietary machine-learning algorithm in the Notal OCT Analyzer prepares an automated analysis. If retina fluid is detected, a report is sent to the treating physician by the Notal Vision Diagnostic Clinic. Learn more.
B+L Announces Agreement With Modulight to Develop Photodynamic Laser
Bausch + Lomb entered into an exclusive agreement with Modulight, a designer and manufacturer of lasers and optics for personalized medicine, to develop a new laser designed for use with Bausch + Lomb’s Visudyne (verteporfin for injection) photodynamic therapy. Visudyne is an injectable photosensitizer drug indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. Activated through use of a photodynamic laser via direct laser excitation, it delivers a targeted approach aimed at destroying abnormal choroidal blood vessels, preventing further disease progression and helping patients maintain vision. Read more.
Alimera Announces Canadian Regulatory Approval for Iluvien
Alimera Sciences announced that Health Canada has approved Iluvien for the treatment of diabetic macular edema. A fluocinolone acetonide sustained-release intravitreal implant, Iluvien is approved in the United States to treat DME in patients previously treated with a course of corticosteroids who didn’t have a clinically significant increase in intraocular pressure. Knight Therapeutics, which signed an exclusive Canadian agreement for Iluvien with Alimera in July 2015, will work with public and private payors to seek reimbursement for the implant. Read more.
Coburn Introduces Portable Slit Lamp
Coburn Technologies introduced a portable slit lamp, the SK-LS-1B, to its diagnostics product line. Users who are unable to, or simply can’t, sit comfortably at a traditional slit lamp are able to examine patients via the device's handheld operation, the company says. The slit lamp comes in a custom carrying/storage case. Coburn says the device’s key features include the following:
• A one-touch magnification switch that makes it easier for doctors to perform exams.
• Built with a maximum illumination angle of 60 degrees, the device helps practitioners get a better slit view of the cornea.
• Powered by AA rechargeable or dry cell batteries, the SK-LS-1B operates for more than four hours after being fully charged.
• The slit lamp is designed with 3,500K color temperatures for better viewing, while helping users avoid visual fatigue.
• The device can be connected to an iPhone for capturing images using an optional attachment.
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