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| Vol. 23, #16 • Monday, April 25, 2022 |
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APRIL IS SPORTS EYE SAFETY MONTH
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A Message from Review's Chief Medical Editor, Mark H. Blecher, MD:
Limit Your Screen Time
In my Forum in Review’s May issue, I talk about telemedicine in ophthalmology, addressing the quality and medical impact of remote eye exams. I’d also now like to comment on its effects on the management of eye-care practices and the potential issues of cost and efficiency. We need to distinguish between remote office visits and remote diagnostics. The latter is in common use in many subspecialties in ophthalmology and can serve a vital function in health-care screening. True telemedicine eye exams are another matter.
While it’s much more efficient for the patient to sit at home and use FaceTime—or whatever app you use—it still isn’t simple. Between patients who aren’t tech savvy, glitchy connectivity and limitations on what we can examine, the experience is often less-than-satisfying for both parties. And no matter how good you are at setting up this modality, there’s no way to see as many patients as if you and they were in a well-run office setting, not to mention the flexibility you’d have in order to obtain testing or specialty exams on the spot.
In the absence of game-changing technology to perform remote exams rather than simply remote testing, it can’t really extend our medical services. Telemedicine can be a useful adjunct for screening and follow-up for certain diagnoses but should be used in addition to, rather than instead of, traditional office-based exams.
Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology
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New Algorithm to Measure VF Using VBLR in Glaucoma Patients
Researchers, who previously reported a visual field prediction model using the variational Bayes linear regression (VBLR) method was useful for accurately predicting VF progression in glaucoma, constructed a VF measurement algorithm using VBLR to evaluate its usefulness. One of the authors is an employee of Kowa, whose perimeter uses the VBLR method under study.
A total of 122 eyes of 73 patients with open-angle glaucoma were included. VF measurements were performed using the currently proposed VBLR measure with AP-7700 perimetry (Kowa). VF measurements were also conducted using the Swedish interactive thresholding algorithm (SITA) measurement with the Humphrey field analyzer. VF measurements were performed using the 24-2 test grid. Visual sensitivities, test-retest reproducibility and measurement duration were compared between the two algorithms.
Here are some of the findings:
• Mean deviation values with SITA standard were -7.9 and -8.7 dB (first and second measurements), while those with VBLR-VF were -8.2 and -8 dB, respectively. No significant differences were found across these values.
• The correlation coefficient of MD values between the two algorithms was 0.97 or 0.98. Test-retest reproducibility didn’t differ between the two algorithms.
• Mean measurement duration with SITA standard was six minutes and two seconds, or six minutes and zero seconds (first or second measurement), while a significantly shorter duration was associated with VBLR-VF (5 minutes and 23 seconds, or 5 minutes and 30 seconds).
Researchers concluded that VBLR-VF reduced the test duration while maintaining the same accuracy as the SITA-standard.
SOURCE: Murata H, Asaoka R, Fujino Y, et al. Comparing the usefulness of a new algorithm to measure visual field using the variational Bayes linear regression in glaucoma patients, in comparison to the Swedish interactive thresholding algorithm. Br J Ophthalmol 2021; Jan 13. [Epub ahead of print].
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Predominantly Persistent Intraretinal Fluid in CATT
Investigators described predominantly persistent intraretinal fluid (PP-IRF) and its association with visual acuity, along with retinal anatomic findings at long-term follow-up in eyes treated with pro re nata ranibizumab or bevacizumab for neovascular age-related macular degeneration.
The study involved a cohort within the Participants in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) assigned to PRN treatment.
Investigators assessed IRF presence on optical coherence tomography scans at baseline and monthly follow-up visits by the Duke OCT Reading Center. PP-IRF through week 12, year 1 and year 2 were defined as IRF presence at baseline and ≥80 percent of follow-up visits. Among eyes with baseline IRF, mean VA scores (letters) and change from baseline were compared between eyes with and without PP-IRF. Adjusted mean VA scores and change from baseline were also calculated using linear regression analysis to account for baseline patient features identified as predictors of VA in previous CATT studies. Outcomes were also adjusted by concomitant predominantly persistent subretinal fluid.
Primary outcome measures included:
• predominantly persistent intraretinal fluid through week 12, year 1 and year 2;
• VA score and VA change; and
• scar development at year 2.
Here are some of the findings:
• Among 363 eyes with baseline IRF, 108 (29.8 percent) had PP-IRF through year 1 and 95 (26.1 percent) did through year 2.
• Comparing eyes with and without PP-IRF through year 1, mean one-year VA score was 62.4 vs. 68.5 (p=0.002) and was 65 vs. 67.4 after adjustment (p=0.13).
• PP-IRF through year 2 was associated with worse adjusted one-year mean VA score (64.8 vs. 69.2; p=0.006) and change (4.3 vs. 8.1; p=0.01), and two-year mean VA score (63 vs. 68.3; p=0.004) and change (2.4 vs. 7.1; p=0.009).
• PP-IRF through year two was associated with higher two-year risk of scar development (adjusted HR=1.49; p=0.03).
Investigators wrote that approximately one-quarter of eyes had PP-IRF through year 2. PP-IRF through year 1 was associated with worse long-term VA, but the relationship disappeared after adjustment for baseline predictors of VA, although PP-IRF through year 2 was independently associated with worse long-term VA and scar development, investigators added.
SOURCE: Core JQ, Pistilli M, Hua P, et al; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Predominantly persistent intraretinal fluid in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmol Retina 2022; Apr 8. [Epub ahead of print].
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Wavefront Asymmetry in Keratoconus: EASIX Index
This study explored asymmetry in normal and keratoconic eyes, and evaluated the discriminant power of single and combined asymmetry parameters, as part of a retrospective study including 414 patients who had Pentacam Scheimpflug topographic and tomographic imaging in both eyes.
The study included 124 subjects with bilateral normal corneas evaluated for refractive surgery, and 290 subjects with keratoconus.
All elevation-, pachymetric- and volumetric-based data (56 parameters) were electronically retrieved and analyzed. Inter-eye asymmetry was determined by subtracting the lowest value from the highest value for each variable. The degree of asymmetry between each subject's eyes was calculated with intraclass correlation coefficients for all the parameters. The ROC curve helped determine predictive accuracy and helped identify optimal cutoffs and combinations of values.
Here are some of the findings: In the normal/keratoconus subjects the median inter-eye asymmetries were: 0.30/3.45 for K2 (flat) meridian;
• 0.03/0.25 for BFS front;
• 1.00/15.00 for elevation back BFS apex; and
• 7.00/29.00 for pachy minimum.
Scientists proposed that, in addition to Rabinowitz's Kmax inter-eye asymmetry, pachymetric, elevation-based and high-order corneal wavefront inter-eye asymmetry parameters could improve the diagnostic options for keratoconus.
SOURCE: Mehlan J, Steinberg J, Druchkiv V, et al. Topographic, tomographic, and corneal wavefront asymmetry in keratoconus: Towards an eye asymmetry index EASIX. Graefes Arch Clin Exp Ophthalmol 2022; Apr 9. [Epub ahead of print].
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Complimentary CME Education Videos
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Macular Choroidal Thickness and Risk of Referable DR in Type 2 Diabetes
Researchers looked at the associations between choroidal thickness and two-year incidence of referable diabetic retinopathy, as part of a prospective cohort study.
Patients with type 2 diabetes in Guangzhou, China, ages 30 to 80 years underwent comprehensive exams, including standard 7-field fundus photography. Macular CT was measured using a commercial swept-source optical coherence tomography device (DRI OCT Triton, Topcon). The relative risk (RR) with 95% confidence intervals helped quantify the association between CT and new-onset RDR. The prognostic value of CT was assessed using the area under the ROC curve, net reclassification improvement (NRI) and integrated discrimination improvement (IDI).
Here are some of the findings:
• A total of 1,345 patients with diabetes were included in the study, and 120 (8.92 percent) had newly developed RDR at the two-year follow-up.
• After adjusting for other factors, the increased RDR risk was associated with:
o greater HbA1c (RR=1.35; CI, 1.17 to 1.55, p<0.001);
o higher systolic blood pressure (SBP; RR=1.02, CI, 1.01 to 1.03; p=0.005);
o lower triglyceride (TG) level (RR=0.81; CI, 0.69 to 0.96, p=0.015);
o presence of diabetic retinopathy (DR; RR=8.16, CI, 4.47 to 14.89; p<0.001); and
o thinner average CT (RR=0.903; CI, 0.871 to 0.935; p<0.001).
• The addition of average CT improved NRI (0.464 ±0.096; p<0.001) and IDI (0.0321 ±0.0068, p<0.001) for risk of RDR.
• The addition of average CT also improved the AUC from 0.708 (CI, 0.659 to 0.757) to 0.761 (CI, 0.719 to 0.804).
Researchers determined that CT thinning, measured by SS-OCT, was an early imaging biomarker for the development of RDR, suggesting that alterations in CT play an essential role in DR occurrence.
SOURCE: Wang W, Li L, Wang J, et al. Macular choroidal thickness and the risk of referable diabetic retinopathy in type 2 diabetes: A 2-year longitudinal study. Invest Ophthalmol Vis Sci 2022; Apr 1;63(4):9.
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Industry News
Zeiss Announces FDA Nod for Quatera 700
Zeiss Medical Technology announced FDA clearance for its Quatera 700 phaco technology, which includes the Zeiss patented Quattro Pump, which the company says is “designed to deliver an exceptional level of chamber stability independent of intraocular pressure and flow.” Zeiss says the device is intended to increase the surgeon’s workflow efficiency, enabling one digitally integrated surgical workflow as a single view or dashboard that integrates patient data from other systems and the microscope. Read more.
Orasis Announces Phase III Topline Results of CSF-1
Orasis Pharmaceuticals announced that Phase III NEAR-1 and NEAR-2 clinical trials, which evaluated the efficacy and safety of its novel eye drop candidate, CSF-1, met their primary and key secondary endpoints. Additional details of these trials will be presented at future medical meetings and will serve as the basis for the New Drug Application submission to FDA in the second half of 2022. Read more.
ASCRS Annual Meeting Presentations
The following companies announced presentations at the American Society of Cataract and Refractive Surgery annual meeting (April 22 to 26) in Washington, D.C.
• Bausch + Lomb’s results from the first of two Phase III trials of the investigational treatment NOV03 (perfluorohexyloctane) for signs and symptoms of dry-eye disease associated with meibomian gland dysfunction are being presented, along with findings from studies involving the enVista MX60E intraocular lens, enVista toric MX60ET IOL, Crystalens AO IOL, Stellaris Elite vision enhancement system, ClearVisc dispersive ophthalmic viscosurgical device and eyeTELLIGENCE digital integration platform. Read more.
• Allergan presentations include new data on Vuity (pilocarpine HCl ophthalmic solution) 1.25%, the first FDA-approved eye drop for the treatment of presbyopia; and the Xen Gel glaucoma stent. Learn more.
• Oyster Point Pharma authors are presenting on fellow-eye outcomes with the Tyrvaya (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry-eye disease in ONSET-1 & ONSET-2 studies. Learn more.
• RxSight announced that its Light Adjustable Lens system, composed of the RxSight Light Adjustable Lens, RxSight Light Delivery Device and accessories, will be the subject of various surgeon presentations. Learn more.
• Johnson & Johnson Vision will present and/or support 46 company-sponsored and investigator-led studies evaluating innovations and outcomes across its surgical portfolio at the meeting. Learn more.
• Alcon announced approximately 150 abstracts featuring the company’s ophthalmic products and equipment. Learn more.
• Aerie Pharmaceuticals announced findings will be presented from a study group's experience with the use of netarsudil in patients with Fuchs’ corneal dystrophy and a Phase IIb study of AR-15512 in dry eye disease, and an independent research poster will feature use of netarsudil after glaucoma surgery. Learn more.
• Sight Sciences announced that data from clinical studies of the Omni Surgical System will be presented. Learn more.
New Appointments
• Ocuphire Pharma announced the appointment of Jay Pepose, MD, PhD, as its chief medical advisor. Read more.
• Graybug Vision announced the appointment of Dirk Sauer, PhD, to its board of directors, effective April 13. Read more.
Centricity Makes Some Changes
Centricity, maker of the Zepto capsulotomy device, recently appointed Leonard Borrmann, Pharm. D, to lead its research and development department.
The company also mentioned that it's working on a new project called Zeptolink which, it says, will use the irrigation and aspiration capabilities of a surgeon's phaco machine to provide suction for the Zepto capsulotomy procedure, putting control of suction, energy delivery and capsule release in the phaco foot pedal. Read more.
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