From the editors of Review of Ophthalmology:
In this issue: (click heading to view article)
Short- and Long-term Variability of IOP Measured with an Intraocular Telemetry Sensor
Researchers evaluated the short- and long-term variability of intraocular pressure in eyes with primary open-angle glaucoma in 22 individuals who had previously been implanted with a sulcus-based IOP sensor (EyeMate, Implandata). Two of the authors are consultants for Implandata.
The participants were requested to obtain at least four IOP measurements per day. Data were grouped according to the eye and medication so that an eye treated with a particular medication was considered as one group, and the same eye treated with a different medication during the observation period was considered a different group.
A day was divided in seven periods:
- Night: Midnight to 5:59 am;
- Early: 6 am to 7:59 am;
- Morning: 8 am to 10:59 am;
- Noon: 11 am to 1:59 pm;
- Afternoon: 2 pm to 5:59 pm;
- Evening: 6 pm to 8:59 pm;
- Late: 9 pm to 11:59 pm.
Short-term variability at a particular period was defined as the variability in IOP measurements obtained during that period on different days within three months of each other. Long-term variability was defined as the variability in IOP measurements obtained during a particular period on different days over a time period of at least one year. Variability was assessed using intraclass correlation coefficients (ICCs).
The mean age of study participants was 67.8 ±6.8 years; 36.4 percent were female. The mean follow-up duration was 19.2 ±21.3 months (median: 9, range: 1 to 58). Here were some of the findings:
- Overall, 92,860 IOP measurements over 15,811 measurement days were obtained and analyzed during the study period.
- The number of measurements obtained from each eye ranged from one per day to 277 per day.
- ICCs for short-term variability among the seven periods during the day ranged from 0.52 (morning) to 0.66 (early).
- Long-term ICCs ranged from 0.29 (night) to 0.51 (late).
Researchers wrote that continual IOP monitoring showed that IOP had moderate short-term and high long-term variability in glaucoma patients. They added that the findings demonstrated that single IOP measurements don’t characterize day-to-day variations in IOP. Moreover, researchers wrote, the findings showed the importance of continual IOP monitoring in glaucoma patients.
SOURCE: Mansouri K, Rao HL, Weinreb RN, et al. Short-term and long-term variability of intraocular pressure measured with an intraocular telemetry sensor in patients with glaucoma. Ophthalmology 2020; July 11. [Epub ahead of print].
Complimentary CME Education Videos
Efficacy & Safety of Epimacular Brachytherapy for Previously Treated nAMD: The MERLOT Trial
Although anti-vascular endothelial growth factor treatment offers better outcomes than the natural history of neovascular age-related macular degeneration, investigators wrote that a less burdensome, less expensive and more durable treatment is needed. They assessed the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular nAMD.
The Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) device trial was conducted at 24 National Health Service hospitals across the UK. Individuals who had nAMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible individuals were randomized 2:1 and stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab, or just as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at final visits at month 36. Masking of participants and clinicians wasn’t possible, but best-corrected visual acuity and imaging were analyzed by masked assessors. Analyses followed the intent-to-treat approach.
Interventions included pars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs. as-needed ranibizumab monotherapy.
Coprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more, or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size and foveal thickness on optical coherence tomography.
Of 363 participants, 329 (90.6 percent) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean age of the combined groups was 76.5 ±7.4 years. Here were some of the findings:
- The mean number of ranibizumab injections was 9.3 ±6.7 in the EMB group and 8.3 ±4.5 in the ranibizumab group, with a difference of one injection (CI, -0.3 to 2.3; p=0.13).
- The mean BCVA change was -11.2 ±15.7 ETDRS letters in the EMB group and -1.4 ±10.9 ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (CI, -6.7 to -12.9).
- In the EMB group, 65.6 percent of participants (160 of 244) lost fewer than 15 ETDRS letters vs. 86.6 percent (103 of 119) in the ranibizumab group, with a difference of 21 percent (CI, 12.4 to 29.5 percent; p<0.001).
- Microvascular abnormalities occurred in 20 of 207 eyes (9.7 percent) in the EMB group and one of 97 eyes (1 percent) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns.
Investigators reported that the MERLOT trial found that, despite the acceptable safety of EMB, it didn’t reduce the number of ranibizumab injections and was actually associated with worse visual acuity than anti-VEGF treatment alone. They added that these results don’t support EMB use as an adjunctive treatment for chronic, active nAMD.
SOURCE: Jackson TL, Soare C, Petrarca C, et al. Evaluation of month-24 efficacy and safety of epimacular brachytherapy for previously treated neovascular age-related macular degeneration: The MERLOT randomized clinical trial. JAMA Ophthalmol 2020; July 09. [Epub ahead of print].
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Lower Corneal Haze & Aberrations in DMEK vs. DSAEK in Fellow Eyes for Fuchs’
Scientists evaluated the long-term corneal changes in patients with Fuchs’ endothelial corneal dystrophy contributing to superior postoperative visual outcomes after Descemet’s membrane endothelial keratoplasty compared with Descemet’s stripping automated endothelial keratoplasty.
Using retrospective analysis, scientists evaluated nine individuals with FECD who underwent DSAEK in one eye and DMEK in the fellow eye. Individuals were genotyped for the triplet repeat expansion in the TCF4 gene and imaged using optical coherence tomography, Scheimpflug imaging and in vivo confocal microscopy through focusing.
Here were some of the findings:
- Eight of nine subjects were genotyped, and all were found to harbor the triplet repeat expansion.
- The average time between endothelial keratoplasty and imaging was 76 ±22 after DSAEK, and 37 ±9 months after DMEK.
- The mean best spectacle-corrected visual acuity (logMAR) was 0.04 ±0.05 in the DMEK eyes vs. 0.11 ± 0.03 in the DSAEK eyes (p=0.02).
- Posterior corneal higher order aberrations were less in the DMEK eyes (0.25 ±0.06) compared with fellow DSAEK eyes (0.66 ±0.25)(p≤0.01).
- Using confocal microscopy through focusing, scientists found that persistent anterior stromal haze was correlated between right and left eyes (r=0.73, p≤0.05), but total stromal backscattering was higher for DSAEK eyes (p≤0.05).
Scientists determined that DSAEK resulted in higher total stromal backscattering (haze) compared with DMEK because of the addition of stromal tissue. They added that lower higher-order aberrations of the posterior cornea and lower total stromal backscattering (haze) may both contribute to superior visual outcomes after DMEK vs. DSAEK.
SOURCE: Waldrop WH, Gillings MJ, Robertson DM, et al. Lower corneal haze and aberrations in Descemet membrane endothelial keratoplasty versus Descemet stripping automated endothelial keratoplasty in fellow eyes for Fuchs endothelial corneal dystrophy. Cornea 2020; July 6. [Epub ahead of print].
Macular Vessel Density in Diabetes and DR with SS-OCTA
Researchers wrote that previous studies on the association between macular vessel density and diabetic retinopathy have had conflicting conclusions. So they assessed the alterations of macular vessel density and other factors in diabetic patients, using swept-source optical coherence tomography angiography in a large-scale sample from Chinese communities.
Patients with type 2 diabetes without histories of ocular treatment were recruited from 2017 to 2018. The average and quadrant parafoveal vessel densities (PVDs) were obtained with a commercial SS-OCTA device (Triton, Topcon). The univariate and multivariate linear regression was used to analyze the correlation of PVD with diabetic retinopathy, diabetic macular edema, HbA1c and other factors.
A total of 919 individuals were included in the final statistical analysis. Here were some of the findings:
- After adjusting for other confounding factors, the DR patients had significantly lower average PVD (β,-1.062; CI, -1.424 to -0.699; p<0.001) in comparison with those without DR.
- In addition, individuals with mild DR or vision-threatening diabetic retinopathy (VTDR) also had significantly lower PVD (p<0.001 for mild DR, and p=0.008 for VTDR) compared with those without DR.
- Age and HbA1c were significantly related to PVD measurements, as shown by multivariable linear regression.
- Individuals with DME had a significantly lower average PVD and temporal PVD than those without DME (p<0.05).
Researchers found that reduced PVD was independently associated with more severe DR, older age, higher HbA1c level and the presence of DME. They wrote that the findings suggested that macular vessel alterations in DR warrant further evaluation in longitudinal studies.
Source: Xie N, Tan Y, Liu S, et al. Macular vessel density in diabetes and diabetic retinopathy with swept-source optical coherence tomography angiography Graefes Arch Clin Exp Ophthalmol 2020; July 13. [Epub ahead of print].
Genentech Releases Phase III Data of PDS
Genentech announced results from the Phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration. In Archway, 98.4 percent of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, the company says. In addition, PDS was generally well-tolerated, with a favorable benefit-risk profile. PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months. The new data will be discussed virtually during the 38th Annual Meeting of the American Society of Retina Specialists on July 26. A recorded presentation of these data is now available to ASRS attendees through the meeting web portal. Read more.
Alcon Upgrades Ngenuity Viewing System
Alcon recently launched an upgrade for its heads-up 3-D viewing system, Ngenuity, and will showcase it at the virtual ASRS meeting. The company says the system’s 1.4 upgrade streamlines the setup for Datafusion, (which integrates the company’s Constellation vitreoretinal surgery system with Ngenuity), and allows retinal surgeons to track surgical parameters in real-time. The company says the upgrade also supports operating-room spacing and setup to minimize the risk of spreading coronavirus.
This latest version of the Ngenuity System will also be available for the anterior segment in late July, the company says.
The new features for cataract surgeons will include a display of the Centurion Vision System’s surgical parameters for real-time surgical feedback, as well as a view of the data from the ORA VerifEye+ intraoperative aberrometer and the aberrometer’s reticle.
The company will also highlight data that it says shows the performance benefits of the Hypervit Dual Blade Vitrectomy Probe, as well as COVID-19 resources at the virtual meeting. Read More.
Numab and Boehringer Ingelheim to Develop Multi-specific Antibody Therapeutics
Boehringer Ingelheim and Numab Therapeutics have entered into a research collaboration and worldwide licensing agreement that includes development of novel therapies for geographic atrophy. The collaboration brings together Boehringer Ingelheim’s expertise in the research and development of breakthrough therapies, and Numab’s multi-specific antibody platform. Read more.
Araim’s Cibinetide Shows Potential for Efficacy in DME
Araim Pharmaceuticals announced the publication of results from an exploratory clinical trial indicating efficacy of lead compound cibinetide in the treatment of diabetic macular edema. The study was sponsored by the Belfast Health and Social Care Trust. Cibinetide is a first-in-class synthetic peptide designed to activate innate repair mechanisms in the setting of tissue injury as a result of the inflammatory cascade. Read more.
Iveric Adds Dr. Blumenkranz to Board
Iveric bio announced the election of Mark S. Blumenkranz, MD, MMS, HJ Smead Professor Emeritus of Ophthalmology at Stanford University, to its board of directors, effective July 15. Dr. Blumenkranz is a vitreoretinal specialist with contributions in the area of novel pharmaceuticals for macular diseases, ocular gene therapy, new laser systems, and ophthalmic tele-health and technology development. Dr. Blumenkranz is a co-founder, and chief executive officer and chairman of Kedalion Therapeutics, and serves as a director of Verana Health, BVI Visitec, Combangio Corp. and One Medical. Read more.
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