From the editors of Review of Ophthalmology:
Monday, December 16, 2019
DECEMBER IS SAFE TOYS AND CELEBRATIONS MONTH
In this issue: (click heading to view article)
Lifecycles of Subretinal Drusenoid Deposits & Outer Retinal Atrophy in AMD
Researchers described the progression and regression of individual subretinal drusenoid deposits (SDDs) and surrounding photoreceptors in individuals with age-related macular degeneration over a 3.5-year period, using multimodal imaging including adaptive optics scanning laser ophthalmoscopy, as part of a longitudinal, observational study.
Four individuals with intermediate AMD were included. Researchers imaged six eyes of four individuals with intermediate AMD four times over 3.5 years. Five eyes of three individuals had only SDDs and no drusen. Researchers assessed SDD presence and progression by multimodal imaging and a three-stage grading system based on spectral-domain coherence tomography. They examined the morphology and fine structures of individual SDD lesions identified at baseline by AOSLO at follow-up visits. And they evaluated reflectivity of photoreceptors surrounding SDDs in AOSLO and SD-OCT.
Main outcome measures included morphology, fine structure and size of SDD lesions by AOSLO; photoreceptor integrity surrounding SDDs via AOSLO and SD-OCT; and retinal layer thicknesses via SD-OCT. Here were some of the findings:
• Individual SDDs followed independent lifecycle trajectories, exhibiting growth, shrinkage, fusion and disappearance.
• Alterations in shape, morphology and internal structure were not obviously due to presence of invading phagocytes.
• Of 822 lesions across all stages examined at baseline, 566 (69 percent) grew, 123 (15 percent) shrank, 47 (6 percent) remained of similar size, 86 (11 percent) disappeared and five (0.6 percent) reappeared after regression.
• A return of characteristic photoreceptor reflectivity in AOSLO (punctate) and in SD-OCT (prominent ellipsoid zone) was observed after regression of some SDD in five eyes of four individuals.
• All eyes exhibited thinning of photoreceptor layers, despite intact retinal pigment epithelium, to ∼70 percent of baseline thicknesses, as well as poorly visible or undetectable outer retinal bands.
Researchers wrote that AOSLO and SD-OCT imaging of individual SDDs over 3.5 years revealed independent trajectories of progression and regression, which they believed reflected the activities of local outer retinal cells. They added that restoration of some photoreceptor reflectivity and intact RPE after SDD regression should be seen in the larger context of outer retinal atrophy, previously suggested as a new form of advanced AMD and replicated in the current findings.
Source: Zhang Y, Wang X, Sadda SR, et al. Lifecycles of individual subretinal drusenoid deposits and evolution of outer retinal atrophy in age-related macular degeneration. Ophthalmology Retina 2019; Oct. 30. [Epub ahead of print].
Predictors of Long-term VF Fluctuation in Glaucoma Patients
Investigators identified predictive factors for visual field fluctuation in glaucoma patients, as part of a retrospective cohort study. A total of 1,392 eyes (816 patients) with ≥6 VFs and ≥3 years of follow-up were included.
• For each eye, the VF mean deviation was regressed against time to model the series trend, and the root mean square error was estimated as a measure of variability. Similarly, the threshold sensitivity at individual test locations was regressed against time, the residuals for a single eye were pooled and the RMSE was calculated. The following baseline variables were tested as potential predictors:
• eye laterality;
• intraocular pressure;
• central corneal thickness;
• number of glaucoma medications;
• spherical equivalent, best-corrected visual acuity;
• lens status;
• previous glaucoma surgery;
• smoking; and
• family history of glaucoma.
The following longitudinal variables were tested: IOP fluctuation; length of follow-up; frequency of VFs; glaucoma/cataract surgery; rate of VF decay; and median false positive, false negative and fixation loss rates. Variables were selected with LASSO regression.
Main outcome measures included predictors of global and pointwise VF long-term fluctuation. Here were some of the findings:
• In the global model, predictors of VF fluctuation were:
o left eye (0.063 dB, p=
o Asian descent (0.265 dB, p=
o larger IOP fluctuation (0.051 dB, p<
o intervening cataract surgery (0.090 dB, p=
o longer follow-up (0.130 dB, p<
o worse baseline MD (-0.145 dB, p<
o faster VF decay rates (-0.090 dB, p<
o higher false positives (FP) (0.145 dB, p<
o higher false negatives (FN) (0.220 dB, p<
• In the pointwise model, predictors of increased fluctuation were:
o larger IOP fluctuation (0.039 dB, p=
o longer follow-up (0.340 dB, p<
o higher VFs frequency (0.238 dB, p=
o intervening glaucoma surgery (0.190 dB, p=
o worse baseline MD (-0.535 dB, p<
o faster VF decay rates (-0.340 dB, p<
o higher FPs (0.255 dB, p<
o higher FNs (0.395 dB, p<
The multivariable model explained 57 percent of the pointwise variances and 28 percent of the global variances.
Investigators found that nearly 60 percent of the pointwise variance could be explained by a multivariable model. They wrote that, in the presence of factors predictive of high fluctuation, increased frequency of testing and better analytics would help identify VF progression more accurately.
SOURCE: Rabiolo A, Morales E, Kim JH, et al. Predictors of long-term visual field fluctuation in glaucoma patients. Ophthalmology 2019; Dec. 5. [Epub ahead of print].
Structural En Face OCT Imaging to Identify Leaky Microaneurysms in DME
Scientists studied the correspondence between fluorescein angiography and structural en face optical coherence tomography in the identification of leaky microaneurysms in diabetic macular edema.
Fourteen eyes of eight individuals with DME (six males and two females, mean age 67.3 ±8.5) were included. For all eyes, scientists obtained a 6 × 6 mm structural en face image of the middle retina and it superimposed on a FA image. They evaluated the reflectivity, capsulation and association with intraretinal cystic fluid (IRCF) of microaneurysms on en face, depending on their leaky status on FA. Here were some of the findings on the 320 leaky microaneurysms evaluated:
• A total of 280 (89 ±8.2 percent) coincided with those on en face OCT images.
• Twenty-nine leaky microaneurysms (10.6 ±6.9 percent) were hyperreflective, and 20 (6.5 ±7.8 percent) demonstrated capsular appearance.
• A majority (97.9 ±3.2 percent) were associated with IRCF.
• From 146 found only on en face images, 130 (88.2 ±15.7 percent) were hyperreflective, 33 (23.9 ±15.6 percent) demonstrated capsular structure and 13 (9.2 ± 15 percent) demonstrated no associated IRCF.
• After exclusion of microaneurysms of the inner retina, 95.4 ±5.4 percent were identified on en face images.
• En face imaging demonstrated 83.5-percent sensitivity and 89.4-percent specificity (area under the ROC curve, 0.87) in the identification of leaky microaneurysms.
Scientists reported that structural en face imaging was comparable to FA in identifying leaky microaneurysms in DME. They added that moderate reflectivity, the absence of capsular structure and neighboring intraretinal cystic fluid indicated leaky microaneurysms.
SOURCE: Maltsev DS, Kulikov AN, Burnasheva MA, et al. Structural en face optical coherence tomography imaging for identification of leaky microaneurysms in diabetic macular edema. Int Ophthalmol 2019; Dec 3. [Epub ahead of print].
Corneal Injury Detection Using Apple iOS-Based Application Technology
Researchers described the feasibility of an attachment-free, Apple iOS-based cobalt blue light application to accurately detect corneal injury.
They removed the corneal epithelia from New Zealand White rabbits by gentle scraping with a dulled scalpel or by using a classic biopsy punch (2 mm in diameter). Then they examined each cornea using a smartphone-enabled blue light, after applying a fluorescein sodium ophthalmic strip. They captured photographs of each cornea before and after using the smartphone-based light with a second smartphone device.
The iOS-based cobalt blue light effectively illuminated fluorescein dye in all ex vivo
samples. Both circular punch biopsies and linear scalpel-induced corneal injuries were readily identified.
Researchers concluded that the iOS-based cobalt blue light was a portable, low-cost and effective alternative to commercially available cobalt blue lights.
SOURCE: Hakimi AA, Heidari AE. Corneal injury detection using Apple iOS-based application technology. Cornea 2019; Dec 4. [Epub ahead of print].
B+L Introduces Envista Toric Mx60et IOL with Stableflex Technology
Bausch + Lomb introduced the enVista toric MX60ET hydrophobic acrylic intraocular lens with StableFlex technology, designed to provide improved material properties for enhanced optic recovery following delivery. Similar to the enVista toric MX60T, the MX60ET offers a glistening-free optic and a broad range of cylinder powers as low as 1.25 D, making the lenses the only domestically available IOLs that correct <1 D of astigmatism at the corneal plane, the company says. The enVista family of lenses, which includes monofocals and torics, have features intended to help compensate for the eye’s natural imperfections, B+L adds. The company says its Trusight aspheric optic design combines strong image quality and depth of field with increased resistance to scratches and abrasions. Step-vaulted AccuSet haptics enable extensive interaction with the capsular bag to aid in securing the lens position, and the SureEdge design features a continuous 360-degree square edge with the goal of preventing posterior capsular opacification, the company adds. Read more.
J&J Vision Introduces Tecnis Toric II
Johnson & Johnson Vision announced the FDA approval and U.S. launch of the Tecnis Toric II 1-Piece Intraocular Lens. This is the first product approved on the new Tecnis Toric II platform, which the company says has more surface texture and friction on the IOL haptics, ostensibly to avoid postop rotation. The company is launching two post-market clinical trials to demonstrate the rotational stability and visual outcomes offered by the Tecnis Toric II platform. The trials will be conducted at up to 50 sites across the United States to collect qualitative and quantitative data from up to 1,000 patients. Read more.
Genentech/Roche Complete Patient Enrollment in TENAYA & LUCERNE Phase III Clinical Trials
Genentech and Roche have completed patient enrollment in the TENAYA and LUCERNE Phase III clinical trials investigating faricimab for the treatment of wet age-related macular degeneration. This follows the completion of patient enrollment in the companies’ Phase III YOSEMITE and RHINE diabetic macular edema clinical trials in September 2019. Genentech and Roche are ending 2019 having fully recruited the current faricimab Phase III clinical trial program, including more than 3,000 patients in two diseases, ahead of schedule. The companies say that faricimab is the first bispecific antibody designed specifically for the treatment of retinal diseases. This investigational medicine simultaneously binds to and neutralizes Angiopoietin-2 and vascular endothelial growth factor A. By targeting both Ang2 and VEGF-A, faricimab may lead to improved and sustained efficacy at longer treatment intervals, thereby delivering better vision outcomes for patients, the companies say.
Biogen Completes Enrollment of Phase III Gene Therapy Study
Biogen announced enrollment of the last patient in its global Phase III STAR clinical study, evaluating the investigational gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia. STAR is a randomized, masked, prospective, parallel-controlled group study that enrolled 170 adult males with CHM to evaluate the safety and efficacy of a single subretinal injection of the agent. The primary endpoint is the proportion of patients with an improvement of at least 15 letters from baseline in best-corrected visual acuity at 12 months post treatment as measured by the Early Treatment Diabetic Retinopathy Study visual acuity protocol. Read more.
Link Between Macular Degeneration and Retinitis Pigmentosa
University of Houston researchers are targeting retinitis pigmentosa and macular degeneration by exploring a protein in the retina that links the conditions: peripherin2 (PRPH2). They will examine how different mutations in PRPH2 lead to different disease phenotypes, contributing to variability among patients carrying the same mutation, the role ROM1 plays in these events and how to shift PRPH2-associated severe phenotypes to milder ones. Read more.
ImprimisRx’s Outsourcing Facility is Issued California License
ImprimisRx announced that its FDA-registered 503B outsourcing facility received a non-resident operating license and has begun shipping into California. This license allows California-based ophthalmologists, optometrists, surgery centers and hospitals to order and stock ImprimisRx’s more than 40 ophthalmic products for on-demand administration to their patients. Read more.
Canon Realigns Strategy to Prepare for Eye-care Systems Growth
The eye-care business operations within Canon U.S.A. will transfer to Canon Medical Systems U.S.A., effective Jan. 1, 2020. The company says Canon’s shift in business operations will enable Canon Medical Systems to offer ophthalmologic solutions to integrated-delivery network customers, while leveraging medical imaging business synergies to address population health challenges associated with chronic conditions such as age-related macular degeneration, diabetic retinopathy and inherited retinal diseases. Canon Medical Systems will add measurement systems, retinal cameras and optical coherence tomography systems to its product line. Read more.
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