Review of Ophthalmology Online


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Volume 18, Number 19
Monday, May 7, 2018
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MAY IS HEALTHY VISION MONTH



In this issue: (click heading to view article)
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######### Dex Implant for DME in Naive vs. Refractory Eyes: IRGREL-DEX Study
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######### OCTA Macular Vascular Density Measurements & Central 10-2 VF in Glaucoma
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######### Systemic & Ocular Determinants of Peripapillary RNFL Thickness
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######### Frequency of Complications During Preparation of Corneal Lamellae for Posterior Lamellar Keratoplasty Pneumodissection
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  Briefly

 

Dex Implant for DME in Naive vs. Refractory Eyes: IRGREL-DEX Study

Researchers investigated the efficacy and safety of repeated dexamethasone implants over 24 months in treatment-naive diabetic macular edema eyes compared with eyes refractory to anti-vascular endothelial growth factor treatment, in a real-life environment. This multicenter, retrospective study assessed best-corrected visual acuity and central subfield thickness (CST). Safety data (intraocular pressure rise and need for cataract surgery) were recorded.

A total of 130 eyes from 125 individuals were included. Baseline best-corrected visual acuity and CST were similar for naive (n=71) and refractory eyes (n=59). Vision in both groups improved significantly after 24 months (p<0.001). However, naive eyes gained statistically significantly more vision than refractory eyes (11.3 ±10 vs. 7.3 ±2.7 letters, p=0.01) and were more likely to gain ≥10 letters (OR 3.31, CI 1.19 to 9.24, p=0.02). At six, 12 and 24 months, CST was significantly decreased compared with baseline in both naive and refractory eyes; however, CST was greater in refractory eyes than in naive eyes (313 ±125 vs. 279 ±61 μm, p=0.10).

Over a follow-up period of 24 months, vision improved in DME eyes after treatment with dexamethasone implants—in treatment-naive eyes as well as in eyes refractory to anti-VEGF treatment; however, improvement was greater in naive eyes.

SOURCE: Iglicki Matias, Busch C, Zur D, et al. Dexamethasone implant for diabetic macular edema in naive compared with refractory eyes: The International Retina Group real-life 24-month multicenter study. The IRGREL-DEX Study. Retina 2018; April 24. [Epub ahead of print].





OCTA Macular Vascular Density & Central 10-2 VF with Glaucoma

Investigators evaluated the association between macular vascular density, assessed by optical coherence tomography angiography, and central visual field threshold sensitivities in healthy glaucoma suspects and individuals with glaucoma, in this observational, cross-sectional study.

They enrolled 185 eyes from 38 healthy participants, 31 glaucoma suspects, 72 people with mild glaucoma and 44 individuals with moderate/severe glaucoma from the Diagnostic Innovations in Glaucoma Study who underwent OCTA images of the macula and 10-2 VF testing. Using linear regression models, researchers assessed the relationships between central VF mean sensitivity and superficial macula whole-image vessel density (wiVD), and between the mean sensitivity of the four central points (MS4) of the 10-2 visual field and parafoveal vessel density (pvVD).

In healthy eyes and glaucoma suspect eyes vs. glaucoma eyes with mild and moderate/severe disease:
• mean wiVDs were found to be significantly higher: 52.5 percent and 49.8 percent, vs. 49.4 percent and 45.2 percent; and
• mean pfVDs were found to be significantly higher: 54.9 percent and 52.1 percent, vs. 51.8 percent and 47.7 percent (ANCOVA p<0.001).
• The univariate associations between 10-2 mean sensitivity and wiVD (R2=26.9 percent) and between 10-2 MS4 and pfVD (R2=16.8 percent) were statistically significant (p<0.001 for both).
• After adjusting for scan quality, age, gender and intraocular pressure, superficial macular wiVD and pfVD were still independently associated with central VF loss.
• Macular wiVD performed better (AUROC=0.70) than ganglion cell complex thickness (AUROC=0.50) for differentiating between glaucoma suspect and healthy eyes (p=0.010).

Investigators determined that loss of OCTA macula vessel density was associated with central 10-2 VF defects. They added that macular vessel density was a clinically relevant parameter that might enhance monitoring of glaucoma suspects and those diagnosed with the disease.

 

SOURCE: Penteado R, Zangwill C, Linda M, et al. Optical coherence tomography angiography macular vascular density measurements and the central 10-2 visual field in glaucoma. J Glaucoma 2018; Apr 16. [Epub ahead of print].



Systemic & Ocular Determinants of Peripapillary RNFL Thickness

Scientists analyzed systemic and ocular determinants of peripapillary retinal nerve fiber layer thickness (pRNFLT) in a European population, as part of a cross-sectional meta-analysis.

They included 16,084 European adults from eight cohort studies (mean age range, 56.9 ±12.3 to 82.1±4.2 years) of the European Eye Epidemiology consortium. Scientists examined associations with pRNFLT measured by spectral-domain OCT using multivariable linear regression and pooled results from random effects meta-analyses. Main outcome measures included determinants of pRNFLT.

Mean pRNFLT ranged from 86.8 ±21.4 μm in the Rotterdam Study I to 104.7 ±12.5 μm in the Rotterdam Study III. Scientists found the following factors to be associated with reduced pRNFLT:
• older age (β=-0.38 μm/year; CI, -0.57 to -0.18);
• higher intraocular pressure (β=-0.36 μm/mmHg; CI, -0.56 to -0.15);
• visual impairment (β=-5.50 μm; CI, -9.37 to -1.64);
• history of systemic hypertension (β=–0.54 μm; CI, -1.01 to -0.07); and stroke (β=–1.94 μm; CI, -3.17 to -0.72).
• A suggestive, non-significant association was observed for dementia (β=-3.11 μm; CI, -6.22 to 0.01).
• Higher pRNFLT was associated with more hyperopic spherical equivalent (β=1.39 μm/diopter; CI, 1.19 to 1.59) and smoking (β=1.53 μm; CI, 1 to 2.06) for current smokers compared with never-smokers.

In addition to previously described determinants such as age and refraction, researchers found that systemic vascular and neurovascular diseases were associated with reduced pRNFLT. They wrote that these factors might be of clinical relevance, especially in monitoring glaucoma with newly occurring vascular comorbidities.

SOURCE: Mauschitz MM, Bonnemaijer PWM, Diers K, et al. Systemic and ocular determinants of peripapillary retinal nerve fiber layer thickness measurements in the European Eye Epidemiology (E3) population. Ophthalmology 2018; Apr 28. [Epub ahead of print].




Frequency of Complications During Preparation of Corneal Lamellae for Posterior Lamellar Keratoplasty Pneumodissection

Researchers determined the formation frequency of various bubble types, the potential impacts of donor and lamella parameters on frequency, and possible risk factors for unsuccessful “big-bubble” creation, in preparation for pre-Descemet’s endothelial keratoplasty with peripheral stromal support and using the big-bubble technique.

Donor age and sex, death-to-preservation time, storage time, presence of corneal scars (mainly a condition after cataract surgery) and endothelial cell density of 256 donor corneas were assessed before the procedures.

• Mean donor age was 62.3 ±8.5 years (28.3 percent women and 71.7 percent men).
• Mean endothelial cell density of the donor grafts was 2,866 ±255 cells/mm2.
• Mean death-to-preservation time was 10.12 ±4.88 hours, and mean storage time of the transplant before surgery was 6.5 ±4.8 days.
• Corneal scars were present in 17 donor grafts (6.6 percent) after cataract surgery; 11 corneas (4.3 percent) were devalued because of Descemet’s membrane rupture during preparation.
• Standard bubble type I was created in 182 corneas (71.7 percent); bubble type II was created in 27 corneas (9.9 percent); both bubble types formed simultaneously in several cases (10.5 percent); and no bubble was created in 47 corneas (18.4 percent).

Researchers identified higher endothelial cell density, shorter death-to-preservation time and the presence of corneal scars after cataract surgery as risk factors threatening bubble formation. They noted that the only risk factor in this study for creating type II bubbles was higher donor age.

Source: Studeny P, Netukova M, Hlozanek M, et al. Frequency of complications during preparation of corneal lamellae used in posterior lamellar keratoplasty using the pneumodissection technique (big bubble). Cornea 2018; April 26. [Epub ahead of print].





  • Aerie Launches Rhopressa (netarsudil ophthalmic solution) 0.02% in the United States
    Now that Aerie Pharmaceuticals’ Rhopressa is available in the United States, the ophthalmic solution is available through national and regional U.S. pharmaceutical distributors, and individuals have access to it through local pharmacies across the nation. Rhopressa (netarsudil ophthalmic solution) 0.02%—FDA approved in December 2017—is a novel, once-daily eye drop for the lowering of elevated intraocular pressure in individuals with glaucoma and ocular hypertension, designed to increase the outflow of aqueous humor through the trabecular meshwork. Read more.



  • Novartis Presents Phase III Brolucizumab Data on 12-Week Dosing Predictability
    Novartis presented new data from the HAWK and HARRIER Phase III trials at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting (April 29 to May 3) in Honolulu. HAWK and HARRIER are 96-week, prospective, double-masked, multi-centered Phase III studies randomizing subjects 1:1:1 to brolucizumab (RTH258) 3 mg (n=358), brolucizumab 6 mg (n=360) or aflibercept 2 mg (n=360) (HAWK), or 1:1 with either brolucizumab 6 mg (n=370) or aflibercept 2 mg (n=369) (HARRIER). Data on a secondary endpoint examining the predictability of 12-week dosing for individuals with neovascular age-related macular degeneration treated with brolucizumab were presented for the first time at the meeting. The majority of individuals with a need for q8 were identified during the first q12 interval (80 percent of the brolucizumab 6-mg group in HAWK and 78 percent of the brolucizumab 6-mg group in HARRIER). Individuals receiving brolucizumab 6 mg who successfully completed the first q12w interval had an 87.4 percent and 82.5 percent probability of remaining on q12w treatment until week 48 in HAWK and HARRIER, respectively (82.6 percent probability for the 3-mg brolucizumab arm of HAWK). Brolucizumab subjects who were successfully identified as being suitable for the q12w interval dosing in the first q12w interval immediately after loading were likely to remain on q12w treatment for the remainder of the study.



  • Sight Sciences Initiates U.S. Trial of TearCare System for Dry Eye
    Sight Sciences launched the OLYMPIA study, a trial to evaluate the safety and effectiveness of the TearCare System in individuals with dry eye disease. According to the company, the system is the world’s first and only wearable therapeutic eyelid technology that is fully customizable and allows the individual’s eyes to remain open and blinking during the procedure. Soft, flexible powered devices conform to the eyelids to deliver a sufficient level of energy for a specific period of time to liquefy meibum, the company wrote in a press release. A randomized, controlled trial will evaluate the safety and effectiveness of the system in the treatment of the signs and symptoms of dry eye disease in comparison to a daily regimen of warm compress therapy and lid massage. Read more.



  • Optos Unveils Next-generation UWF with OCT Capabilities for U.S.
    Optos, part of Nikon Corp., announced that it launched Monaco, the first ultra-widefield imaging device combined with OCT, in the United States. Monaco, a new compact desk-top UWF retinal imaging device, provides greater imaging functionality and represents the company’s first imaging device with ultra-widefield color imaging, three-in-one color depth imaging and autofluorescence modalities combined with OCT. The device is designed to enhance pathology detection and disease management, and improve clinical flow. Read more.



  • Avedro Secures $25 Million in Funding
    Avedro secured $25 million in financing led by Lilly Asia Ventures, with participation from existing investors OrbiMed Advisors, InterWest Partners and HealthQuest Capital. Avedro will leverage this funding to invest in product development, clinical studies and commercial efforts. Read more.



  • Bausch + Lomb Reports Updated ARMOR Study Results
    Bausch + Lomb announced the results from the ninth consecutive year of the Antibiotic Resistance Monitoring in Ocular Microorganisms surveillance study, presented at the 2018 Association for Research in Vision and Ophthalmology Meeting in Honolulu. Researchers also presented preliminary 2017 surveillance data on antibiotic resistance levels. The nine-year trend analysis confirmed the previously noted decrease in methicillin resistance among Staphylococcus aureus (from 39 percent to 14 percent; p<0.001) but not among coagulase-negative staphylococci (p=0.455), with more than half of CoNS demonstrating continued persistence in MR. Further analysis showed decreased resistance among S. aureus to azithromycin (62 percent to 52 percent), ciprofloxacin (39 percent to 16 percent), tobramycin (24 percent to 6 percent), and chloramphenicol (6.6 percent to 4.4 percent), and among CoNS to ciprofloxacin (46percent to 22 percent); p≤0.005 for all. Read more.



  • 4DMT and ROCHE Expand Partnership to Develop AAV Gene Therapies
    4D Molecular Therapeutics expanded its 2016 research agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. to develop and commercialize several ophthalmology products, including 4DMT’s intravitreally delivered choroideremia clinical candidate, 4D-110. 4DMT will be responsible for vector discovery and optimization, product design and engineering, pre-clinical and early-stage clinical development, and manufacturing, while Roche will conduct clinical trials and globally commercialize the new therapeutics. Read more.



  • OWL Appoints Fries as Executive Director
    OWL: Advancing Diversity in Leadership, an organization dedicated to driving innovation and patient care by advancing diversity in eye care leadership, announced that Gaynor Fries was appointed executive director of the organization. Gaynor has been a key part of the support team behind OWL since July 2015. With a bachelor’s in business administration and a certificate in non-profit management from Duke University, she brings more than 25 years of experience as an administrator and management consultant for several organizations. This news comes after the success of OWL’s Signature & Networking events during this year’s American Academy of Cataract & Refractive Surgery meeting in Washington, D.C. Learn more.



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