From the editors of Review of Ophthalmology:
OCTOBER IS HALLOWEEN SAFETY MONTH
In this issue: (click heading to view article)
Vitrectomy With Intravitreal Dexamethasone Implant for Refractory ME Secondary to DR, RVO & Noninfectious Posterior Uveitis
Researchers analyzed the efficacy of an intraoperative intravitreal dexamethasone implant for macular edema secondary to diabetic retinopathy, retinal vein occlusion and noninfectious posterior uveitis, as part a retrospective review of 62 individuals (29 men and 33 women; mean age 51.19 ±14.41 years; 65 eyes).
They postoperatively assessed best-corrected visual acuity (in logMAR), central foveal thickness, intraocular pressure and postoperative edema-free periods up to one year. Researchers compared preoperative and postoperative numbers of other intravitreal injections.
• Best-corrected visual acuity gradually improved in the DME group (from 0.87 to 0.51, or around 20/160 to 20/63) but failed to improve from month three onward in the RVO and uveitis groups.
• Central foveal thickness decreased in all groups, especially in the DME group (from 550.93 to 338.10 μm).
• The edema-free period was longest in the DME group (19.34 ±15.12 months), followed by the uveitis (12.91 ±7.85 months) and RVO (8.50 ±8.76 months) groups.
• Subjects in the uveitis group used more IOP-lowering agents (1 ±1.27) than those in the DME (0.13 ±0.49) and RVO (0.36 ±0.79) groups.
• Increased IOP events were most frequent in postoperative week one, especially in the uveitis group.
Researchers concluded that vitrectomy combined with an intravitreal dexamethasone implant for DME, RVO and noninfectious posterior uveitis had a favorable clinical outcome.
SOURCE: Pang JP, Son G, Yoon YH, et al. Combined vitrectomy with intravitreal dexamethasone implant for refractory macular edema secondary to diabetic retinopathy, retinal vein occlusion, and noninfectious posterior uveitis.
Retina 2018; Oct 10. [Epub ahead of print].
Glaucoma Drainage Devices for Uveitic Glaucoma and a Meta-analysis of the Literature
Investigators assessed the efficacy of glaucoma drainage devices in uveitic glaucoma and non-uveitic glaucoma, and performed a meta-analysis of previously published results to compare with the findings, as part of a retrospective, case-control study.
All eyes that underwent GDD surgery were included from 2015 onward. Then investigators performed a literature review of the PubMed database to compare their results. A total of 99 eyes were included (38 with uveitic glaucoma). The preoperative IOP was 25.9 ±7.7 mmHg and 27.9 ±9.6 mmHg for individuals with and without uveitis (p=0.277).
• Investigators found no significant differences between individuals with uveitis (44.9 percent) and without uveitis (42.8 percent) in the final IOP or reduction in IOP).
• Within the first year after surgery, 13.2 percent of cases with uveitis developed macular edema vs. 6.6 percent without uveitis (p=0.267); and 15.8 percent of uveitis cases developed a transient hypotony vs. 8.2 percent without uveitis (p=0.242).
• A meta-analysis of 24 studies showed a postoperative weighted mean difference of -17.8 mmHg, and 2.2 fewer IOP-lowering medications in uveitic glaucoma compared with -13.2 mmHg and 3.5 fewer meds in cases without uveitis in the current study.
Investigators found that GDD surgery in individuals with uveitis had a similar effect on IOP as cases without uveitis. They determined that the risks of developing macular edema and hypotony were slightly higher in people with uveitis, but the results weren’t statistically significant. Investigators wrote that these findings were in line with previous reports, but pointed out that data on the efficacy of GDD surgery and macular edema in uveitic glaucoma was scarce.
SOURCE: Ramdas WD, Pals J, Rothova A, et al. Efficacy of glaucoma drainage devices in uveitic glaucoma and a meta-analysis of the literature. Graefes Arch Clin Exp Ophthalmol 2018; Oct 11. [Epub ahead of print].
Prevalence of CME, Epiretinal Membrane and Cataract in RP
Scientists looked at the prevalence of treatable complications (cystoid macular edema, epiretinal membrane and cataract) in consecutive cases with retinitis pigmentosa at a tertiary eye clinic in 2012.
They used spectral-domain optical coherence tomography to determine the presence of CME and ERM, and reviewed clinical records to identify cataract and pseudophakia. Multivariable analyses adjusted for age, gender and other confounders.
• In 338 eyes of 169 subjects, CME was present in 58.6 percent of individuals and 50.9 percent of eyes, and was bilateral in 73.7 percent.
• ERM was present in 22.8 percent of eyes, cataract in 23.4 percent and pseudophakia in 11.2 percent.
• In multivariable analyses, CME was associated with younger age (OR, 0.81; CI, 0.67 to 0.98) but not with gender.
• Those with ERM and cataracts were less likely to have CME (OR, 0.19; CI, 0.09 to 0.40), as were individuals with ERM and pseudophakia (OR, 0.37; CI, 0.16 to 0.84).
• CME was most prevalent in individuals with autosomal-dominant inheritance (71.4 percent), followed by autosomal recessive/sporadic inheritance (58.9 percent).
• CME was least likely in people with X-linked inheritance (12.5 percent, p<0.001).
Scientists reported that the prevalence of treatable RP complications was high, and suggested that screening individuals with RP to identify those who might benefit from interventions might be clinically beneficial.
SOURCE: Liew G, Strong S, Bradley P, et al. Prevalence of cystoid macular oedema, epiretinal membrane and cataract in retinitis pigmentosa. Br J Ophthalmol 2018; Oct 5. [Epub ahead of print].
Association of Cataract Surgical Outcomes With Late Surgeon Career Stages
Researchers investigated whether an increase in adverse cataract surgical events occurred during later surgeon career stages, as part of a population-based study of 499,650 cataract operations performed in Ontario, Canada, between Jan. 1, 2009, and Dec. 31, 2013.
They used linked health-care databases to study cataract surgical complications while controlling for patient-, surgeon- and institution-level covariates. All ophthalmologists who performed cataract surgery in Ontario within the study period were included in the analysis. Researchers included isolated cataract surgery performed by surgeons at early-, mid- and late-career stages (it’s uncertain how the stages were defined). Four serious adverse events were evaluated: dropped lens fragments; posterior capsule rupture; suspected endophthalmitis; and retinal detachment.
Of 416,502 participants: 244,670 (58.7 percent) were women; 90,429 (21.7 percent) were ages 66 to 70 years; 111,530 (26.8 percent) were ages 71 to 75; 90,809 (21.8 percent) were ages 76 to 80; and 123,734 (29.7 percent) were 81 years or older. Late-career surgeons performed 143,108 of 499,650 cataract operations (28.6 percent) during the study period.
• Late-career stage was not associated with an overall increased risk of surgical adverse events (OR vs. mid-career, 1.06; CI, 0.85 to 1.32).
• In a sensitivity analysis with surgical volume removed from the model, late- career stage still wasn’t associated with overall adverse surgical events (OR, 1.10; CI, 0.88 to 1.38).
• Among individual complications, late-career stage was associated with an increased risk of dropped lens fragment (OR, 2.30; CI, 1.50 to 3.54) and suspected endophthalmitis (OR, 1.41; CI, 1.01 to 1.98).
• Complications corresponded with small absolute risk differences of 0.11 percent (CI, 0.085 to 0.130 percent) for dropped lens fragment and 0.045 percent (CI, 0.028 to 0.063 percent) for suspected endophthalmitis.
Researchers extrapolated that later-career surgeons were performing a substantial proportion of cataract operations with overall low surgical adverse event rates. They suggested that future studies might evaluate the frequency of secondary surgical interventions as additional measures of surgical care quality.
SOURCE: Campbell RJ, El-Defrawy SR, Gill SS, et al. Association of cataract surgical outcomes with late surgeon career stages. JAMA Ophthalmology. 2018; Oct. 11. [Epub ahead of print].
FDA Safety Alert: Increased Risk of Corneal Haze Associated with Raindrop Near Vision Inlay
The Food and Drug Administration issued a notice to alert eye-care providers and patients already implanted with the Raindrop Near Vision Inlay of the increased risk of corneal haze associated with the device. The FDA is advising that eye-care providers not implant Raindrop inlays and is working with Optics Medical to have all remaining product on the market recalled. Raindrop Inlays are no longer being distributed in the United States. Read more.
IDx and Topcon Sign Exclusive AI Platform Agreement
IDx and Topcon signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market, granting exclusive rights to IDx as the only autonomous AI company permitted to sell its products with the Topcon NW400, a robotic fundus camera. In turn, IDx agreed to assign Topcon's NW400 as the only robotic desktop fundus camera with less than a 55-degree field of view to be integrated with the IDx-DR autonomous AI system that instantly detects diabetic retinopathy in fundus images. Read more.
B+L to Launch Surgical Support Applications for Stellaris Elite Vision on IBM Cloud
Bausch + Lomb announced the new eyeTELLIGENCE applications, which will run on the IBM Cloud, that the company says will help eye surgeons and surgical facilities work more efficiently when using the Stellaris Elite vision enhancement system. The companies built the applications with features that include expedited technical support and the ability to synchronize preferred surgical parameters across multiple systems. Using Watson Internet of Things services on the IBM Cloud, Bausch + Lomb will have a centralized view of operational and performance data from its Stellaris Elite systems around the United States. Read more.
Imprimis Subsidiary Initiates Program for Non-Opioid & Noninvasive MK Melt Drug Candidate
Melt Pharmaceuticals announced that additional studies on its drug candidates will begin following a presentation at the American Academy of Ophthalmology annual meeting of clinical data on the MKO Melt (midazolam/ketamine/ondansetron) from a prospective, controlled, randomized, three-arm comparator study. Both new studies, along with an upcoming pre-IND meeting with FDA scheduled for January 2019, will inform the clinical development programs Melt expects to begin during 2019. Read more.
Reliance Partners to Create Ophthalmic Exam Lane
Reliance Medical Products, a division of Haag-Streit USA, says it will reveal at AAO an integrated exam lane concept it says is designed to "elevate the exam experience for the patient and doctor, and offer sleeker and more ergonomic designs." The concept is designed to prevent musculoskeletal disorders that can plague eye-care providers throughout their careers by placing exam instruments lower and more comfortably within reach, Haag-Streit says. To learn more, visit the Haag-Streit booth, #2226, at AAO in Chicago. Read more.
Eylea (aflibercept) Injection Improves DR & Reduces Complications
Regeneron announced that the Phase III PANORAMA trial evaluating Eylea (aflibercept) injection in individuals with moderately severe and severe non-proliferative diabetic retinopathy met 52-week primary and key secondary endpoints. On the primary endpoint, 80 percent of individuals receiving Eylea on an every 8-week interval, and 65 percent of those on an every 16-week interval (after an initial monthly dosing period), experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared with 15 percent of individuals receiving sham injection (p<0.0001). Treatment also reduced vision-threatening complications by 82 to 85 percent and development of center-involved diabetic macular edema by 68 to 74 percent compared with sham injection. Read more.
Alcon to Develop SMART Suite Digital Health Platform For Cataract Surgery
Alcon says it will develop the SMART Suite digital platform designed to streamline, simplify and improve cataract surgery for surgeons and patients. The suite will connect multiple diagnostic and surgical devices through a digital, open, cloud-based infrastructure that seamlessly integrates with practices' existing cataract diagnostic equipment, electronic medical record systems and technologies in the Alcon Cataract Refractive Suite, the company says. Read more.
Quantel Launches Vitra 810TM laser & SubCyclo Probe
Quantel Medical launched the Vitra 810TM laser and SubCyclo probe (FDA Pending) at the American Academy of Ophthalmology annual meeting in Chicago. Vitra 810 is a v810 nm laser with a clinically oriented software interface so glaucoma and retina treatments can be performed through four guided treatment procedures. The company is also introducing a cyclophotocoagulation probe featuring a unique design enabling thermal and subthreshold cyclophotocoagulation procedures with a single probe. AAO attendees will be able to see the VITRA 810 laser and its new probe at exhibit booth #3056.
I-Med Pharma Partners With Quidel
I-Med Pharma signed an exclusive distribution agreement with Quidel for I-Med Pharma’s I-Lid ’N Lash products, I-Relief Hot & Cold Therapy Eye Mask with Thermabeads and SMTube. Quidel provides InflammaDry and AdenoPlus Eye Health diagnostic assays—rapid point-of-care products for the detection of infectious and inflammatory diseases and conditions of the eye. InflammaDry detects elevated levels of MMP-9, a key inflammatory marker for dry-eye syndrome. AdenoPlus differentiates between viral and bacterial infections of acute conjunctivitis. Read more.
MacuLogix Enters Into International Distribution Agreement With Optos
MacuLogix entered into an international distribution agreement with Optos, a provider of medical retinal imaging company and part of Nikon, Japan. Effective immediately, Optos in Europe and Australia will add the AdaptDx automated dark adaptometer to their existing portfolio of retina-focused medical devices, including the company’s exclusive ultra-widefield retinal imaging products.
Santen Initiates Phase III Program to Evaluate Omidenepag Isopropyl (DE-117) for Glaucoma or OHT
Santen initiated a Phase III development program (SPECTRUM) in the United States to evaluate the investigational use of omidenepag isopropyl (DE-117), a selective agonist for the prostanoid receptor EP2, for the treatment of glaucoma or ocular hypertension. The program includes two Phase III, randomized, double-masked, active-controlled, parallel-group, multicenter trials assessing the efficacy and safety of omidenepag isopropyl 0.002% ophthalmic solution compared with timolol maleate 0.5% ophthalmic solution in individuals with glaucoma or OHT. Read more.
CorneaGen Partners With Visiometrics
CorneaGen is now a U.S. distributor of the HD Analyzer and Tear Film Analyzer from Visiometrics. The HD Analyzer evaluates how clear and stable vision is prior to cataract and refractive procedures. It noninvasively evaluates vision by sending a low-power laser into the eye and taking a picture of the light as it hits the retina. The Tear Film Analyzer, which identifies dry-eye disease, tests a parameter the company calls “Vision Break-Up Time” via a measurement of tear-film instability and a dynamic plot of vision quality over time. It also uses external ocular photography to produce high-definition images of the meibomian glands. Read more.
Eyevance Executes Strategic Transaction
Eyevance acquired FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% from Novartis AG. FLAREX, approved in the United States, is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. Read more.
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