From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
Vascular Complexity Analysis in OCTA of DR
Researchers aimed to verify the feasibility of using vascular complexity features for objective differentiation of controls and nonproliferative diabetic retinopathy and proliferative DR patients.
This was a cross-sectional study conducted in a tertiary, subspecialty academic practice. The cohort included 20 control subjects, and 60 NPDR and 56 PDR patients. Three vascular complexity features—including vessel complexity index, fractal dimension and blood vessel tortuosity—were derived from each optical coherence tomography angiography image. A shifting-window measurement was further implemented to identify local feature distortions due to localized neovascularization and mesh structures in PDR.
Here were some of the findings:
- With mean value analysis of the whole image, only the vessel complexity index and blood vessel tortuosity were able to classify NPDR vs. PDR patients.
- Comparative shifting-window measurements revealed increased sensitivity of complexity feature analysis, particularly for NPDR vs. PDR classification.
- A multivariate regression model indicated that the combining all three vascular complexity features with shifting-window measurements provided the best classification accuracy for controls versus NPDR vs. PDR.
Researchers concluded that vessel complexity index and blood vessel tortuosity were the most sensitive in differentiating NPDR and PDR patients. They added that a shifting-window measurement increased the sensitivity significantly for objective optical coherence tomography angiography classification of diabetic retinopathy.
SOURCE: Alam M, Le D, Lim JI, et al. Vascular complexity analysis in optical coherence tomography angiography of diabetic retinopathy. Retina 2020; June 18. [Epub ahead of print].
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Factors Associated with Postoperative Pain After PRK
Investigators aimed to define the factors that affect patients’ self-assessed postoperative pain after photorefractive keratectomy. Individuals who underwent PRK in 2016 were evaluated. Anonymized data collected included:
- patient gender;
- age and season at the time of surgery;
- ablation depth;
- surgeon status (attending vs. resident);
- topical tetracaine use; and
- subjective pain scores at postoperative days (PODs) one and seven.
Average pain scores and amount of pain medication taken were analyzed for each of the above variables.
Overall, 231 patients who underwent PRK were analyzed. Here were some of the findings:
- The mean pain score and SD were 0.78 ±1.87 on POD 1 and 0.03 ±0.37 by POD 7.
- Individuals who used topical tetracaine reported significantly higher pain on POD one (p<0.000) and seven (p=0.038) compared with patients who didn’t use tetracaine.
- No significant differences in pain scores were seen based on:
- surgeon status;
- ablation depth;
- gender; or
- Patients who used topical tetracaine took a higher amount of oral pain medication (9.44 ±6.01) compared with those who didn’t (7.02 ±4.71)(p=0.022).
Investigators determined that postoperative pain was significantly elevated in patients who used tetracaine on POD one and POD seven. They found that these patients were also more likely to take oral pain medication than those who didn’t use topical tetracaine. As a result of these findings, they suggested that oral pain medication should be evaluated to assess efficacy and safety in inhibiting ocular pain after PRK.
SOURCE: Palochak CAM, Santamaria J, Justin GA, et al. Assessment of factors associated with postoperative pain after photorefractive keratectomy. Cornea 2020; June 16. [Epub ahead of print].
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Real-world Impact of IOP Control on Rates of RNFL Loss
Scientists looked at the impact of intraocular pressure control on rates of change of spectral-domain optical coherence tomography retinal nerve fiber layer thickness in a real-world large clinical population, as part of a retrospective cohort study.
A total of 85,835 IOP measurements and 60,223 SD-OCT tests from 14,790 eyes of 7,844 patients were included. Data were extracted from the Duke Glaucoma Registry. Scientists included all records from individuals with a minimum of six months of follow-up, and at least two good-quality SD-OCT scans and two clinical visits using with Goldmann applanation tonometry. Eyes were categorized according to the frequency of visits, with IOP below cutoffs of 21 mmHg, 18 mmHg and 15 mmHg over time. Rates of change for global RNFL thickness were obtained using linear mixed models and classified as:
- slow, if change was slower than -1 μm/year;
- moderate, if between -1 and -2 μm/year; and
- fast, if faster than -2 μm/year.
Multivariable models were adjusted for age, gender, race, diagnosis, central corneal thickness, follow-up time and baseline disease severity. Main outcome measures included rates of change of SD-OCT RNFL thickness according to levels of IOP control. Here were some of the findings:
- Eyes had a mean follow-up of 3.5 ±1.9 years.
- The average rate of change in RNFL thickness was -0.68 ±0.59 μm/year.
- Each 1 mmHg higher mean IOP was associated with 0.05 μm/year faster RNFL loss (p<0.001) after adjustment for potentially confounding variables.
- In faster-progressing eyes, at all follow-up visits, 41 percent had IOP <21 mmHg, 20 percent had IOP <18mmHg and 9 percent had IOP <15mmHg.
Scientists reported that IOP was significantly associated with rates of progressive RNFL loss in a real-world large clinical population. In addition, they wrote that eyes with stricter IOP control over follow-up visits had less chance of exhibiting fast deterioration. Scientists pointed out that their findings may assist clinicians in establishing target pressures in clinical practice.
SOURCE: Jammal AA, Thompson AC, Mariottoni EB, MD, et al. Real-world impact of intraocular pressure control on rates of retinal nerve fiber layer loss in a large clinical population. Ophthalmology 2020; June 20. [Epub ahead of print].
MA Incidence & Progression in nAMD Eyes Treated with VEGF Inhibitors Using a T&E or PRN Regimen: MANEX Study
Researchers compared the incidence and progression of macular atrophy in eyes with neovascular age-related macular degeneration treated with anti-vascular endothelial growth factor agents using a treat-and-extend or pro re nata regimen over four years in a real-life setting, as part of a multicenter, retrospective, comparative study.
Participants included 264 individuals with treatment-naïve nAMD. Consecutive patients with nAMD received anti-VEGF therapy according to a T&E (n=163) or PRN (n=101) regimen. Eyes were included if they had received anti-VEGF injections for at least four years, and had annual fundus autofluorescence (FAF) and optical coherence tomography imaging using the Heidelberg Spectralis. Two masked graders independently delineated areas of MA from serial FAF images using Heidelberg region finder software, and growth rates were calculated. Incident MA was assessed using proportional hazard ratios.
Main outcome measures included MA incidence and progression over four years, association between treatment strategy and number of injections. Here were some of the findings:
- At baseline, MA was present in 24 percent of T&E group and 20 percent of the PRN group (p=0.32).
- At year four, in the T&E group, 27 percent of eyes (34/124) without baseline MA had detectable MA; and in the PRN group, 25 percent of eyes (20/81) without baseline MA had detectable MA.
- In eyes with MA at baseline, the mean square root area of MA progressed by a rate of 0.4 ±0.2 in the T&E group and by 0.4 ±0.1 mm/year in the PRN group (p=0.23).
- Multivariate analysis for baseline predictors of MA growth including older age, poorer baseline VA and presence of RAP revealed a higher risk of greater MA progression (p=0.03).
- Regression analysis demonstrated no association between T&E and PRN treatment strategies relative to the risk of developing new MA during four years of follow-up, or risk of progression of pre-existing MA at year four (p=0.692).
Researchers reported that, over four years, neither incidence nor progression of macular atrophy in nAMD eyes treated with anti-VEGF injections were influenced by the treatment regimen or injection frequency. They added that eyes treated with a T&E regimen received more injections and had better visual outcomes compared with those treated with a PRN approach.
Source: Spooner KL, Fraser-Bell S, Cozzi M, et al. Macular atrophy incidence and progression in eyes with neovascular age-related macular degeneration treated with VEGF inhibitors using a treat-and-extend or a pro-re-nata regimen. Four year results of the MANEX study. Ophthalmology Retina 2020; June 13. [Epub ahead of print].
J&J Vision Announces FDA Clearance of CatalyS cOS 6.0 Software
Johnson & Johnson Vision announced FDA 510(k) clearance of new software for the Catalys Precision Laser System with advanced astigmatism management. The software—the result of a collaboration with Cassini Technologies B.V.—is designed to simplify astigmatism management workﬂow and increase operational efficiency. The latest improvements include advanced visualization that provides full-volume, 3D, high-resolution and streaming optical coherence tomography imaging, among other features. Read more.
U.S. Government Sues Regeneron
The U.S. Attorney’s Office in Masachusetts recently announced that the government has filed a civil False Claims Act complaint against Regeneron. The complaint alleges that “Regeneron paid tens of millions of dollars in kickbacks for its macular degeneration drug Eylea (aflibercept), using a foundation as a conduit to cover co-pays for Eylea.” For its part, in a statement Regeneron states, “There is no merit to the civil complaint filed by the U.S. Attorney for the District of Massachusetts. It is unfortunate that a misguided lawsuit is attempting to assign wrongful intent to entirely legal conduct. Regeneron has fully cooperated with the government's investigation and will vigorously defend the company's case.”
Ocutrx Vision Selects Karten to Finalize Oculenz AR Headset Design
Ocutrx Vision Technologies, a global developer and manufacturer of augmented reality (AR) and extended reality (XR) headsets, says it will soon come out with the finished version of the Oculenz ARwear headset; Karten Design was chosen to enhance design elements for commercial launch next year. The new headset, with a resolution of 60 pixels-per-degree, will be the highest-resolution AR/XR headset in the market, according to the company. In the first quarter of 2021, Ocutrx is planning to release the commercial version of its AR/XR headset that the company says helps improve vision for patients with low vision from conditions such as advanced macular degeneration. Read more.
AsclepiX Announces $35 Million Series A Financing
AsclepiX Therapeutics closed a $35 million Series A financing. The company says the proceeds will fund Phase I/IIa clinical trials of AXT107, the AsclepiX’s lead investigational drug, for the treatment of diabetic macular edema, wet age-related macular degeneration and macular edema secondary to retinal vein occlusion. Read more.
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