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| Vol. 22, #41 • Monday, October 4, 2021 |
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OCTOBER IS HALLOWEEN SAFETY MONTH
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Glare and Mobility Performance in Glaucoma: A Pilot Study
Researchers evaluated glare disability and its impact on mobility and orientation in glaucoma patients.
Twenty-two glaucoma patients and 12 age-matched control subjects were included. All patients underwent a clinical evaluation of visual function and halo size measurements to determine glare disability with a glare score of the best eye (GS-BE) and worse eye (GS-WE). Mobility was evaluated by four mobility courses on an artificial street (StreetLab) under photopic conditions (P) and mesopic conditions, with an additional light source in front of the patient to mimic dazzling conditions (M+G). Mobility time, mobility incidents, trajectory segmentation, distance traveled, preferred walking speed on trial (WS) and percentage of preferred walking speed (PPWS) were recorded. In addition, the Nasa task load index (Nasa-TLX) was evaluated.
Here are some of the findings:
• GS-WE and GS-BE were significantly higher in glaucoma patients than in the control group (p=0.001 and p=0.003).
• Significant differences between moderate glaucoma patients and controls (p=0.001 and p=0.010, respectively), and between severe glaucoma patients and controls (p=0.049 and p=0.016) were reported.
• In locomotion tasks, comparing performance under M+G and P conditions, mobility performance was significantly different concerning mobility time (p=0.010), distance traveled (p=0.008), WS (p=0.007), PPWS (p=0.006) and Nasa-TLX (p=0.017) in the glaucoma group.
• Under M+G lighting conditions, mobility performance for glaucoma patients was significantly worse than controls with regard to WS (p=0.038), PPWS (p=0.0498), mobility time (p=0.046) and Nasa-TLX (p=0.006).
Researchers reported glare disability observed in patients with moderate and severe glaucoma had an impact on their mobility performance.
SOURCE: Bertaud S, Zenouda A, Lombardi M, et al. Glare and mobility performance in glaucoma: A pilot study. J Glaucoma 2021; Sep 10. [Epub ahead of print].
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Real-world Outcomes & Treatment Patterns in Patients Treated with Anti-VEGF for nAMD in Sweden
Investigators analyzed and compared the number and interval of anti-vascular endothelial growth factor injections in neovascular age-related macular degeneration patients, as well as visual development in patients followed up for one to three years in clinical practice and during different index periods.
The observational study included treatment-naïve eyes with nAMD from the Swedish Macula Register that started treatment between 2007 and 2017. The eyes were stratified by different index periods (2007 to 2010; 2011 to 2013; 2014 to 2015; and 2016 to 2017) and by follow-up cohorts for each index period of one, two or three years (cohorts 1 to 3). Their intravitreal anti-VEGF treatment was assessed by number of injections, injection intervals, visual acuity and near VA change.
Here are some of the findings:
• From the earliest index period (2007 to 2010) to the latest (2016 to 2017), the number of injections increased for the comparable follow-up time: 6.2 ±1.4 vs. 8.3 ±2 injections after year one, 4.8 ±1.6 vs. 6.7 ±2.4 during year two.
• The last injection interval was 73 ±34 days after one, 71 ±33 after two, and 67 ±32 after thee years of follow-up for the index period 2014 to 2015.
• For the same period, the percentage of eyes with at least two consecutive 12- to 16-week injection intervals over one-, two- and three-year follow-up increased 5.2 percent, 15 percent and 17.5 percent, respectively.
• Baseline VA for eyes indexed 2016 to 2017 increased and presented with 62.1 ±13.4 letters compared with 57.7 ±13.5 letters in 2007 to 2010; p<0.0001.
Investigators reported, from the earliest to the latest index periods, the number of injections increased for the comparable follow-up time. At the same time, they wrote, baseline and near VA, and outcomes improved continuously.
SOURCE: Schroeder M, Westborg I, Fluur C, et al. Exploration of real-world outcomes and treatment patterns in patients treated with anti-vascular endothelial growth factors for neovascular age-related macular degeneration in Sweden. Acta Ophthalmol 2021; Sep 20. [Epub ahead of print].
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Complimentary CME Education Videos
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Impact of DMEK on Visual Quality in Patients with Fuchs'
Scientists evaluated short-term (three months follow-up) changes in visual quality following Descemet’s membrane endothelial keratoplasty for Fuchs’ endothelial dystrophy (FED).
In the prospective institutional case series, 51 patients that underwent DMEK for FED were included. Assessment included the Quality of Vision (QoV) questionnaire preoperatively, at one month and three months after surgery. Secondary outcome measures were anterior segment parameters acquired by Scheimpflug imaging, corrected-distance visual acuity (CDVA) and endothelial cell density (ECD).
Here are some of the findings:
• Glare, hazy and blurred vision, and daily fluctuation in vision were the most symptoms reported preoperatively.
• All symptoms demonstrated a significant reduction of item scores for severity, frequency and bothersome nature in the course after DMEK (p<0.01).
• Glare and fluctuation in vision remained to some extent during the follow-up period (median score=1).
• Preoperatively, corneal densitometry correlated moderately to weakly with severity of hazy vision (rs=0.39; p=0.03) and frequency (rs=0.26; p=0.02), as well as severity of blurry vision (rs=0.27; p=0.03).
• CDVA and central corneal thickness didn’t correlate with visual complains.
Scientists found, following DMEK for FED, patient-reported visual symptoms assessed by the QoV questionnaire represented a useful tool providing valuable information on the impact of DMEK on visual quality that couldn’t be directly estimated by morphological parameters and visual acuity only.
SOURCE: Ademmer V, Agha B, Shajari M, et al. Impact of DMEK on visual quality in patients with Fuchs' endothelial dystrophy. Graefes Arch Clin Exp Ophthalmol 2021; Sep 16. [Epub ahead of print.]
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Cost Effectiveness Analysis of Intravitreal Aflibercept for Preventing Progressive DR
Researchers calculated costs required to prevent center-involved diabetic macular edema (CI-DME) or proliferative diabetic retinopathy (PDR), and to improve the diabetic retinopathy severity score (DRSS) with intravitreal anti-VEGF injections, as reported for aflibercept in two randomized control trials.
They used a cost-effectiveness analysis modeling based on published data.
They analyzed results from PANORAMA and the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol W. Parameters collected included DRSS score, risk reduction of PDR, risk reduction of CI-DME and number of treatments required. Costs were modeled based on 2020 Medicare reimbursement data practice settings of hospital-based facilities and non-facilities.
Main outcome measure included cost to prevent cases of PDR and CI-DME, and to improve DRSS stage.
Here are some of the findings:
• Over two years in Protocol W, the cost required to prevent one case of PDR was $83,000 ($72,400) in the facility (non-facility) setting; in PANORAMA, the corresponding two-year costs were $89,400 ($75,000) for the 2Q16 arm and $91,200 ($89,900) for the 2Q8PRN arm.
• To prevent one case of CI-DME with vision loss in Protocol W, the cost was $154,000 ($133,000).
• For all CI-DME, with and without vision loss, in PANORAMA, the costs to prevent a case were $70,900 ($59,500) for the 2Q16 arm and $90,000 ($88,800) for the 2Q8PRN arm.
• In Protocol W, the overall accumulated total for cost/DRSS unit change at the two-year point for facility (non-facility) setting was $2,700 ($2,400)/DRSS. In the first year, the cost was $2,100 ($1,800)/DRSS, and in the second year it was $6,100 ($5,300)/DRSS.
Researchers found a considerable cost associated with the prevention of PDR and CI-DME with intravitreal aflibercept injections. They added that a price per unit of change in diabetic retinopathy severity score is a new parameter that might serve as a benchmark in future utility analyses that could be used to bring perspective to cost-utility considerations.
SOURCE: Patel NA, Yannuzzi NA, Lin J, et al. A cost effectiveness analysis of intravitreal aflibercept for the prevention of progressive diabetic retinopathy. Ophthalmol Retina 2021; Sep 18. [Epub ahead of print].
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Industry News
Outlook Therapeutics Reports New Safety Data from Phase III NORSE TWO Trial
Outlook Therapeutics announced new 12-month safety data from the Phase III NORSE TWO trial of ONS-5010 / Lytenava (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration. The company says that the topline data previously reported showed a robust safety profile. Read more.
B+L Announces Topline Results from Second Phase III Trial of NOV03
Bausch + Lomb announced statistically significant topline data from the second Phase III (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) for treating the signs and symptoms of dry eye associated with meibomian gland dysfunction. The MOJAVE trial met both primary sign and symptom endpoints:
• Change from baseline in total corneal fluorescein staining (tCFS) achieved statistical significance at day 57, using the National Eye Institute scale, compared to control (p<0.001).
• Change from baseline in dryness score achieved statistical significance at day 57, as rated on a visual analogue scale ranging from 0 to 100 (0=no dryness; 100=maximum dryness), compared to control (p<0.001).
Read more.
J&J Vision Appoints Dr. Jong as Global Professional Education Lead, Myopia
Monica Jong, BOptom, PhD, was appointed as Global Professional Education Lead, Myopia at Johnson & Johnson Vision. Dr. Jong co-founded and led the International Myopia Institute (IMI). In her new role, she will lead how Johnson & Johnson Vision educates and trains professionals in myopia.
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