Review of Ophthalmology Online



Vol. 22, #2   •   Monday, January 11, 2021


In this Issue:


IOP Telemetry for Managing Glaucoma During COVID-19

Researchers evaluated the feasibility of remotely monitoring intraocular pressure with a telemetric IOP sensor, the eyemate (Implandata GmbH, Germany), in glaucoma patients during the COVID-19 lockdown period, as part of a cross-sectional study. Two of the study authors disclosed they were consultants for Implandata.

Subjects included patients previously implanted with the telemetric IOP sensor. Physicians working remotely collected IOP measurements acquired by the patients during the lockdown period. A questionnaire was sent to 10 participating study centers to evaluate the clinical impact of remote monitoring of IOP via the IOP sensor system.

Data was available from all centers, and from 37 eyes of 37 patients (16 patients with a sulcus-based sensor and 21 patients with a suprachoroidal sensor). Here were some of the findings:
• Thirty-four patients obtained IOP measurements during the lockdown period. The mean age of patients was 69.3 ±9.6 years; 48.6 percent of patients were female.
• A total of 8,415 IOP measurements from 370 measurement days were obtained.
• Based on remote IOP measurements, treatment was changed in five patients.
• In another five cases, treatment change was considered when physicians received the IOP measurements after the lockdown period.
• Nine out of the 10 study centers judged remote IOP measurements to have been clinically impactful.

Researchers reported that the results showed the feasibility of patient-acquired measurements of IOP using an implantable sensor in conjunction with remote IOP monitoring by physicians. They added that the data obtained had an impact on clinical decision-making, including adjustment of ocular hypotensive therapy and avoiding unnecessary office visits during the COVID-19 pandemic.

SOURCE: Mansouri K, Kersten-Gomez I, Hoffmann EM, et al. Intraocular pressure telemetry for managing glaucoma during the COVID-19 pandemic. Ophthalmol Glaucoma 2020; Dec 21. Epub ahead of print.


Macular Microvascular Change Association with Non-Perfusion in BRVO

Investigators evaluated the correlation between macular microvascular alterations on optical coherence tomography angiography and retinal ischemia on ultra-widefield fluorescein angiography (UWF FA) in eyes with branch retinal vein occlusion, as part of a cross-sectional study.

This prospective study was performed between September 2019 and June 2020 at Yeungnam University Medical Center. Investigators included 60 patients with treatment-naïve BRVO. Two independent, masked graders analyzed OCTA parameters, including vessel density, skeletal density, fractal dimension (FD) and UWF FA parameters, including retinal non-perfusion area (NPA) and ischemic index (ISI) from various concentric regions (perimacular region, 0.5 to 3 mm radius; near-peripheral region, 3 to 10 mm; mid-peripheral region, 10 to 15 mm; far peripheral region, >15 mm). A repeated measures analysis of variance test and a paired T test were performed for intervisit and interregional comparisons, and Pearson correlation coefficient and multivariate regression analyses were performed to examine the correlation between UWF FA and OCTA parameters.

Here were some of the findings:
• The OCTA parameters from the superficial and deep capillary plexuses (DCP) were significantly correlated with NPA and ISI in all concentric regions.
• After adjusting for several covariates, all OCTA parameters revealed a significant association with ISI on UWF FA.
• OCTA parameters from DCP were significantly correlated with concentrations of placental growth factor and vascular endothelial growth factor.
• Although all OCTA parameters achieved successful results in obtaining area under the curve >0.9 to detect severe retinal ischemia, defined as ISI >10 percent, FD reduction in DCP was the most reliable parameter (AUC=0.948, p<0.001), and 5.39 percent was the best cutoff point for predicting ISI >10 percent.

Investigators concluded that OCTA is a useful noninvasive tool for evaluation of macular microvasculature and predicting peripheral non-perfusion in eyes with BRVO.

SOURCE: Ryu G, Park D, Lim J, et al. Macular microvascular changes and their correlation with peripheral non-perfusion in branch retinal vein occlusion. Am J Ophthalmol 2021; Jan 4. [Epub ahead of print].


Surgeon-reported Barriers to Performing DALK

Scientists identified barriers and facilitators to adopting deep anterior lamellar keratoplasty for nonendothelial corneal pathology.

They designed an anonymous survey consisting of 22 multiple choice and free text questions to gather information on demographic factors of surgeons and DALK surgical practices, and emailed the survey to members of the kera-net, a global online corneal surgeon/surgery platform.

A total of 100 surgeons completed the survey, most of whom practice in the United States (73 percent). Here were some of the findings:
• Most surgeons (89 percent) reported performing DALK. Surgeons who didn’t learn DALK during fellowship (34 percent) tended to be in practice for higher numbers of years (p<0.001).
• Surgeons in private practice were more likely to perform DALK vs. those in other settings (92.7 percent vs. 80.8 percent, p=0.087).
• Surgeons performing more corneal surgeries (at least 100 per year) were more likely to perform DALK than those who perform fewer than 100 per year (52 percent vs. 14 percent, p=0.01).
• Surgeons who perform Descemet’s membrane endothelial keratoplasty were more likely to perform DALK than those who don’t (81.7 vs. 18.3 percent, p=0.014).
• A positive correlation was found between PK and DALK surgical volumes (Spearman rank correlation coefficient=0.57, p<0.001).
• The main reasons for surgeon preference for DALK over PK were a desire to preserve the endothelium, intraoperative safety and decreased complications.
• Longer surgical time and low patient volume were cited as barriers to adoption of DALK.

Due to the findings, the researchers wrote that adjustments in the DALK technique reducing surgical time and additional learning opportunities for DALK might improve adoption.

SOURCE: Thanitcul C, Mathews P, Woreta FA, et al. Surgeon preference for keratoplasty techniques and barriers to performing deep anterior lamellar keratoplasty. Cornea 2020; Dec 24. [Epub ahead of print].


Anatomical & Clinical Outcomes of nAMD Eyes Treated with Anti-VEGF

Researchers assessed the relationship between subretinal fluid (SRFL), intraretinal fluid (IRFL) and visual outcomes of neovascular age-related degeneration in routine clinical practice.

They identified treatment-naive eyes enrolled in the Fight Retinal Blindness! registry after January 2017. They graded lesion activity at each visit as: inactive; active not SRFL only (A-NSRFL only); or active SRFL only (A-SRFL only). Eyes were grouped based on initial activity: initially A-NSRFL only; or initially A-SRFL only—and further on their predominant activity status over 12 months: mostly inactive; mostly A-NSRFL only; or mostly A-SRFL only.

A total of 703 eyes were eligible for analysis. Here were some of the findings:
• Initially A-NSRFL only had similar adjusted mean 12-month VA change to initially A-SRFL eyes (5.7 vs. 6.9 letters; p=0.165), but the group’s final VA was worse (62.5 vs. 67.5 letters at 12 months; p=0.003).
• Adjusted mean 12-month VA change between the predominant activity groups was significantly different (p=0.005), with mostly inactive (7.6 letters) and mostly A-SRFL only (7.5 letters) eyes gaining more than mostly A-NSRFL only eyes (3.6 letters).

Researchers wrote that eyes with SRFL only had similar outcomes at one year to eyes that were mostly inactive. They added that intraretinal fluid was associated with worse visual outcomes, which they said underscored the importance of distinguishing between IRFL and SRFL when managing nAMD.

SOURCE: Nguyen V, Puzo M, Sanchez-Monroy J, et al. Association between anatomical and clinical outcomes of neovascular age-related macular degeneration treated with anti-VEGF. Retina 2020; Dec 14; [Epub ahead of print].




Complimentary CME Education Videos


Industry News

Gemini Receives FDA Fast Track Designation for GEM103

Gemini Therapeutics announced that GEM103, the company’s investigational treatment for dry age-related macular generation, was granted FDA Fast Track designation. Gemini is evaluating GEM103, a recombinant, human complement factor H. The company’s Phase IIa ReGAtta study is evaluating GEM103 in patients with geographic atrophy secondary to dry AMD. Read more.



Genentech’s Faricimab Meets Primary Endpoint Across Two Phase III DME Trials

Genentech announced positive topline results from two identically designed global Phase III studies, YOSEMITE and RHINE, evaluating the investigational bispecific antibody faricimab in people with diabetic macular edema. Both studies met their primary endpoints and showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared with aflibercept given every eight weeks. Faricimab was generally well-tolerated with no new safety signals identified. In addition, the Phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. Read more.






Kala Pharmaceuticals Announces Availability of Eysuvis

Kala says its dry-eye drug Eysuvis is now available in national and regional U.S. pharmaceutical distribution centers. Patients with a prescription can acquire it through their local retail pharmacies or through home delivery. Eysuvis is approved for the short-term (up to two weeks) relief of the signs and symptoms of dry eye. Read more.



AsclepiX Doses First Patient in Phase I/IIa Trial of AXT107

AsclepiX Therapeutics announced the first patient was dosed in the Phase I/IIa CONGO clinical trial to evaluate the safety and bioactivity of AXT107 in patients with diabetic macular edema. In December 2020, the FDA cleared the Investigational New Drug application for AXT107 for the treatment of retinal diseases including DME, neovascular age-related macular degeneration and macular edema following retinal vein occlusion. AXT107 is an investigational drug candidate that inhibits VEGF-A and VEGF-C, and activates Tie2. Read more.

Ocular Therapeutix Announces Supplemental NDA for Dextenza

Ocular Therapeutix announced submission to the FDA of a supplemental New Drug Application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, the sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Read more.

Heru Completes FDA Registration

Heru, a Bascom Palmer Eye Institute medical technology company developing a next-generation AI platform for vision diagnostics and augmentation, announced its class I listing with the FDA for its cloud-based virtual reality platform’s first diagnostic application for visual field exams. Heru’s platform is designed to autonomously diagnose vision defects and customize individual vision augmentation based on the user’s unique vision defects. Read more.

Volk Releases ClearPod to Solve Mask-related Fogging

Volk Optical released its newest product, the ClearPod, to solve the problem of mask-related fogging during fundus exams. This patent-pending design was created in collaboration with Bradley Sacher, MD, a cataract specialist and Jeremy Wingard, MD, a glaucoma specialist at Wheaton Eye Clinic. When a patient breathes naturally while wearing a mask, air escapes through the gaps in the mask and accumulates on the lens surface causing condensation and obstructing views of the retina and slowing down the exam. The ClearPod clips securely onto the Volk fundus lens and form a barrier, directing air currents away from the lens surface. Learn more. Learn more.

Prevent Blindness Calls for Nominations

Prevent Blindness is calling for nominations for the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health, and the second annual Rising Visionary Award. The deadline for submissions for both awards is February 5. Learn More.



New Hi-Health Division Streamlines Product Ordering Using EHR

Hi-Health says its new eye-care division will help streamline product ordering on electronic health records systems. The company’s Vista line of products will be available to select on the EHR, similar to the way prescriptions are filled out. Eye-care professionals search for the Vista brand, select Hi-Health’s Pharmacy and input orders. Initial product offerings include artificial tears and tea tree oil-based lid cleansing products, along with a family of advanced macular and dry-eye supplements. The company says it chose its unique business model after hearing complaints from doctors that patients’ retail purchases weren’t consistent with their recommended treatments. Learn more about the company.









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