From the editors of Review of Ophthalmology:
Monday, September 16, 2019
SEPTEMBER IS HEALTHY AGING MONTH
In this issue: (click heading to view article)
Macular Atrophy in nAMD: Ranibizumab vs. Aflibercept (The RIVAL Study)
In the Novartis-sponsored RIVAL study, researchers evaluated differences in development of macular atrophy and other efficacy outcomes over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in individuals with neovascular age-related macular degeneration.
As part of the Phase IV, randomized, partially masked, multicenter study, individuals ages ≥50 years diagnosed with active, treatment-naive subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity of ≥23 logMAR letters were included.
Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2 mg, and treated according to the same reading center-guided T&E regimen following three initial monthly injections. The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24.
A total of 278 individuals were included in the analysis (ranibizumab 0.5 mg, n=141; aflibercept 2.0 mg, n=137). Here were some of the findings:
• Mean (CI) change in square root area of MA from baseline to month 24 was +0.36 mm (0.27, 0.45) for ranibizumab and +0.28 mm (0.19, 0.37) for aflibercept; treatment difference: +0.08 mm (-0.05, 0.21; p=
• The proportion of individuals with MA increased from 7 percent (10/141) to 37 percent (43/117) for ranibizumab and from 6 percent (8/137) to 32 percent (35/108) for aflibercept from baseline to month 24.
• The average number of injections received per year (CI) was similar between both groups: 9.6 (9.2, 10) for ranibizumab and 9.5 (9.1, 9.9) for aflibercept.
• The mean change in BCVA (CI) from baseline to month 24 was +6.6 letters (4.7, 8.5) for the ranibizumab group and +4.6 letters (2.7, 6.6) for the aflibercept group, treatment difference (CI): 2 letters (-0.7, 4.6; p=
• Rates of adverse events (AEs) were similar between both groups.
Researchers observed no significant differences in the rate of growth and development of MA over 24 months between ranibizumab and aflibercept in nAMD treated using an identical T&E regimen. They found that ranibizumab and aflibercept resulted in similar visual acuity improvements over 24 months with similar number of injections and AEs.
Source: Gillies MC, Hunyor AP, Arnold JJ, et al. Macular atrophy in neovascular age-related macular degeneration: A randomized clinical trial comparing ranibizumab and aflibercept (the RIVAL study). Ophthalmology 2019; Aug 27. [Epub ahead of print].
Using OCTA to Identify Impact of Slab Selection on Quantification of Choriocapillaris Flow Deficits
Investigators assessed the impact of slab selection on quantitative measurements of choriocapillaris (CC) flow deficits using swept-source optical coherence tomography angiography, as part of a cross-sectional study.
They first generated en face slabs to isolate the CC using the manufacturer’s default setting: a 20 μm-thick slab starting 29 μm posterior to the centerline of the automatically segmented retinal pigment epithelium band. They then adjusted the inner and or outer borders by 2-μm increments to generate CC slabs with a range of offsets relative to the center of the RPE band. They compared flow deficits between the modified slabs to those of the default slab.
Twenty-seven eyes of healthy subjects (mean age: 42 years) were prospectively enrolled. Here were some of the findings:
• Flow deficit percent increased when the slab was shifted outward by ≥4μm and inward by 20 μm (p<0.05).
• Fifteen eyes (55.6 percent) showed large hypointense regions precluding quantification when the slab was shifted inward by 20 μm.
• Those without hypointensity demonstrated a decrease in flow deficit percent when the slab was shifted inward by 10 to 18 μm (p<0.05).
• When modulating slab thickness, CC flow deficit percent increased when the slab thickness became thinner by ≥8 μm and decreased when the slab thickness became thicker by ≥8 μm (p<0.05).
Investigators determined that quantitative CC parameters might be significantly influenced by small differences in the slab selection. They found that slabs close to the RPE could be susceptible to segmentation errors. Investigators wrote that the findings highlighted the importance of an accurate, precise and consistent slab definition to reliably generate quantitative CC metrics from OCTA.
SOURCE: Byon I, Nassisi M, Borrelli E, et al. Impact of slab selection on quantification of choriocapillaris flow deficits by optical coherence tomography angiography. Am J Ophthalmol 2019; Sep 4. [Epub ahead of print].
Refractive Outcomes Using Conventional vs. Total Keratometry for IOL Calculation
Scientists compared the refractive outcomes following cataract surgery using conventional keratometry (K) and total keratometry (TK) for intraocular lens calculations in the SRK/T, HofferQ, Haigis, and Holladay 1 and 2, as well as Barrett and Barrett TK Universal II formulas. One of the authors received honoraria from Carl Zeiss, maker of the TK system in the IOLMaster.
Sixty eyes of 60 individuals from Siriraj Hospital, Thailand, were prospectively enrolled in this comparative study. Scientists assessed eyes using the IOLMaster 700. They recorded posterior keratometry, K, TK, central corneal thickness, anterior chamber depth, lens thickness, axial length and white-to-white corneal diameter. They calculated emmetropic IOL power using K and TK in all formulas, in addition to selected IOL power and predicted refractive outcomes. Furthermore, they measured postoperative manifest refraction three months postoperatively. Finally, they calculated mean absolute errors (MAEs), median absolute errors (MedAEs) and the percentage of eyes within ±0.25, ±0.50 and ±1D of the predicted refraction for all formulas in both groups. Here were some of the findings:
• Mean difference between K and TK was 0.03 D (44.56 ±1.18 vs. 44.59 ±1.22 D), showing excellent agreement (ICC=0.99, all p<
• Emmetropic IOL powers in all formulas for both groups were very similar, with a trend toward lower MAEs and MedAEs for TK when compared with K.
• The Barrett TK Universal II formula demonstrated the lowest MAEs.
• The proportion of eyes within ±0.25, ±0.50 and ±1 D of predicted refraction were slightly higher in the TK group.
Scientists reported that conventional K and TK for IOL calculations showed strong agreement. They suggested that the same IOL constant could be used for both K and TK.
SOURCE: Srivannaboon S, Chirapapaisan C. Comparison of refractive outcomes using conventional keratometry or total keratometry for IOL power calculation in cataract surgery. Graefes Arch Clin Exp Ophthalmol 2019; Sep 5. [Epub ahead of print].
Mitomycin C-augmented Phacotrabeculectomy vs. Phacoemulsification in PACG
Researchers aimed to compare the efficacy and safety of phacotrabeculectomy using releasable sutures and adjunctive mitomycin C vs. phacoemulsification alone in the management of primary angle-closure glaucoma.
In total, 63 eyes of 63 individuals with PACG were randomized to undergo either mitomycin C-augmented phacotrabeculectomy with tight scleral flap closure using releasable sutures aiming at no flow, or phacoemulsification alone. The primary outcomes were success rates and complications. Secondary outcomes were IOP and glaucoma medications. Here were some of the findings:
• The IOP and glaucoma medications were significantly reduced at one, three, six and 12 months postoperatively in both groups (p<
• No statistically significant difference was found in IOP, IOP reduction, success rates or survival times between both groups.
• Glaucoma medications were only significantly lower in the phacotrabeculectomy group at one and three months.
• Rates of postoperative interventions and complications were higher in the phacotrabeculectomy group.
• Complete success, defined as an IOP of 6 to 21 mmHg on no medications and with no signs of glaucoma progression, was achieved in 58 percent in the phacotrabeculectomy group, compared with 62 percent in the phacoemulsification group (p=
• Only two eyes (6 percent) in the phacoemulsification group required a subsequent trabeculectomy.
Researchers concluded that trabeculectomy didn’t seem to add an advantage when combined with phacoemulsification in PACG patients and was associated with more postoperative interventions. They added that, despite the use of releasable sutures to allow titration of the IOP postoperatively, the rate of hypotony and other complications was higher in the phacotrabeculectomy group.
SOURCE: El Sayed YM, Elhusseiny AM, Albalkini AS, et al. Mitomycin c-augmented phacotrabeculectomy versus phacoemulsification in primary angle-closure glaucoma: A randomized controlled study. J Glaucoma 2019; Aug 29. [Epub ahead of print].
First Trifocal IOL Approved in United States
Alcon’s AcrySof IQ PanOptix trifocal IOL has been granted FDA approval, making it the first and only FDA-approved trifocal lens for U.S. patients. The PanOptix is a presbyopia-correcting IOL built on the AcrySof IQ platform that uses ENLIGHTEN Optical Technology, Alcon’s proprietary design for optimizing intermediate vision. The company says this trifocal lens significantly reduces the need for glasses after surgery, and is available in both spherical and toric designs. The company plans to host special launch activities at the 2019 American Academy of Ophthalmology meeting in October. Learn more.
J&J Vision Showcases Latest Data & Solutions at ESCRS Annual Meeting
Johnson & Johnson Vision says it will highlight key clinical data and the latest solutions in its growing portfolio of products designed to improve vision care across generations, at the European Society of Cataract and Refractive Surgeons Annual Meeting in Paris, September 14-18. At ESCRS 2019, Johnson & Johnson Vision will offer a series of educational sessions about the latest advancements in surgery, as well as announce the upcoming availability of its new Tecnis Synergy IOL and preloaded SmartLoad Delivery Technology cartridge designed to optimize monofocal IOL delivery with the reusable Unfolder Vitan inserter. The company says it will also share insights around its latest TearScience LipiScan Dynamic Meibomian Imager and LipiFlow Thermal Pulsation suite of products. The company’s booth is located in Pavilion 7, Floor 7.2 Booth #E112. Learn more.
AAO & Verana Health Launch Verana Practice Insights
The American Academy of Ophthalmology and Verana Health announced the launch of Verana Practice Insights, a new tool enabling physicians to improve patient outcomes and provide better care through critical data insights and trends gleaned from the American Academy of Ophthalmology Intelligent Research In Sight (IRIS) Registry. Verana Practice Insights will gather key data from the registry to provide ophthalmologists with a de-identified aggregate view of practice trends, patient diagnoses and interventions across the United States. Furthermore, the software will enable IRIS Registry participants to benchmark their individual clinical care patterns relative to a cohort of their peers. In October, Verana Health is offering member-only early access to physicians who pre-register for Verana Practice Insights. Verana Practice Insights will initially provide clinical trends related to cataract surgery. In 2020, the software will expand to include additional indications such as glaucoma and retinal conditions, Verana says. For more information and to pre-register for the service, physicians can visit: https://www.veranahealth.com/verana-practice-insights-signup/
Boost Epi-On Corneal Cross-Linking Data to Be Presented at ESCRS
Avedro announced the inclusion of several Boost Epi-On cross-linking presentations in the scientific and educational programs at the 10th EU Cornea Congress and the 37th Congress of the European Society of Cataract and Refractive Surgeons. The presentations will unveil the early clinical experiences of several clinicians who have evaluated the company’s next-generation corneal cross-linking treatment for keratoconus, deemed Boost Epi-On CXL. Boost is a noninvasive corneal cross-linking procedure that doesn’t require removal of the epithelium and addresses the limitations of prior epi-on procedures through the addition of supplemental oxygen, Avedro says. The company is conducting a Phase III clinical trial to evaluate a similar version of the Epi-On procedure in the United States for the treatment of progressive keratoconus. Read more.
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