Review of Ophthalmology Online



Vol. 22, #18  •   Monday, May 3, 2021


In this Issue:


Power to Detect Progression with Different VF Patterns

Researchers compared the variability and ability to detect visual field progression of 24-2, central 12 locations of the 24-2 and 10-2 visual field tests in eyes with abnormal VFs, as part of a retrospective, multisite cohort.

A total of 52,806 24-2 and 11,966 10-2 VF tests from 7,307 eyes from the Glaucoma Research Network database were analyzed. Only eyes with at least five visits and two or more years of follow-up were included.

Linear regression models were used to calculate the rates of mean deviation change (slopes) while their residuals were used to assess variability across the entire MD range. Computer simulations (n=10,000) based upon real MD residuals of the sample were performed to estimate the power needed to detect significant progression (p<5 percent) at various rates of MD change. The main outcome measure was the time required to detect progression.

Here were some of the findings:
• For all three patterns, MD variability was highest within the -5 to -20 dB range, and consistently lower with the 10-2 vs. 24-2 or central 24-2.
• Overall, the time to detect confirmed significant progression at 80 percent power was the lowest with 10-2 VF, with a decrease of 14.6 to 18.5 percent when compared to 24-2; and a decrease of 22.9 percent to 26.5 percent when compared to central 24-2.

Researchers wrote that time to detect central VF progression was reduced with 10-2 MD compared with 24-2 and C24-2 MD in glaucoma eyes in this large dataset, in part because 10-2 tests had lower variability. They added that these findings contribute to the potential value of 10-2 testing in the clinical management of glaucoma patients and in clinical trial design.

SOURCE: Susanna FN, Melchior B, Paula JS, et al. Variability and power to detect progression of different visual field patterns. Ophthalmol Glaucoma 2021. April 9. [Epub ahead of print].




nAMD Treatment Patterns and Outcomes Over a Decade

Management of neovascular age-related macular degeneration has evolved over the last decade with several treatment regimens and different medications. This study described the treatment patterns and visual outcomes over 10 years in a large cohort of patients.

A retrospective analysis of electronic health records from 27 National Health Service secondary care healthcare providers in the UK was undertaken. Participants included treatment-naïve patients receiving at least three intravitreal anti-vascular endothelial growth factor injections for nAMD in their first six months of follow-up. Patients with missing data for age or gender, and those under the age of 55 were excluded.

Eyes with at least three years of follow-up were grouped by years of treatment initiation, and three-year outcomes were compared between the groups. Data were generated during routine clinical care between September 2008 and December 2018. Main outcome measures included visual acuity, number of injections and number of visits.

A total of 15,810 eyes of 13,705 patients receiving 194,904 injections were included. Here were some of the findings:
• Visual acuity improved from baseline during the first year, but dropped thereafter, resulting in loss of visual gains. This trend remained consistent throughout the study decade. Although an increasing proportion of eyes remained in the driving standard, this primarily due to better presenting visual acuities over the decade.
• The number of injections dropped substantially between the first and subsequent years—from a mean of 6.25 in year one, to three in year two and 2.5 in year three, without improvement over the decade.
• In a multivariable regression analysis, final VA improved by 0.24 letters for each year since 2008, and younger age and baseline VA were significantly associated with VA at three years.

Investigators wrote that the findings showed that, despite improvement in functional VA over the years, primarily driven by improving baseline VA, patients continued to lose vision after the first year of treatment, with only marginal change over the next decade. They added that the data suggest the results may be related to suboptimal treatment patterns that haven’t improved over the years. They noted that new treatment approaches such as longer-acting therapies may be warranted.

SOURCE: Schwartz R, Warwick A, Olvera-Barrios A, et al. Evolving treatment patterns and outcomes of neovascular age-related macular degeneration over a decade. Ophthalmol Retina 2021; Apr 15. [Epub ahead of print].


Combined Cataract Surgery and DMEK-S

Scientists evaluated the long-term results of combining cataract surgery, intraocular lens implantation, and Descemet’ membrane endothelial keratoplasty with peripheral stromal support (DMEK-S).

The outcomes of 107 eyes of 37 patients who underwent a combination of cataract surgery, IOL implantation and DMEK-S between October 2007 and February 2015, were retrospectively evaluated. The average follow-up duration was 18.2 ±18.3 months (range, 6 to 84 months). Changes in uncorrected and corrected distance visual acuity, spherical equivalent and corneal endothelial cell density were analyzed. Intraoperative and postoperative complications were also recorded.

Here are some of the findings:
• The mean logMAR uncorrected distance visual acuity improved from 0.92 ±0.60 (around 20/160 Snellen) preoperatively to:
   o 0.33 ±0.33 at six months (a little worse than 20/40);
   o 0.28 ±0.25 at 12 months (a little better than 20/40);
   o 0.24 ±0.20 at 24 months; and
   o 0.27 ±0.27 at 36 months postoperatively (p<0.001).
• The mean logMAR corrected distance visual acuity improved from 0.62 ±0.65 (a little worse than 20/80) preoperatively to:
   o 0.17 ±0.29 at six months (a little worse than 20/25);
   o 0.13 ±0.21 at 12 months;
   o 0.07 ±0.16 at 24 months (a little better than 20/25); and
   o 0.11 ±0.23 at 36 months postoperatively (p< 0.001).
• The mean endothelial cell density decreases were:
   o 50.7 ±21.1 percent at six months;
   o 50.8 ±19.8 percent at 12 months;
   o 60.7 ±16.6 percent at 24 months;
   o 62.2 ±11.8 percent at 36 months; and
   o 61.8 ±20 percent at 48 months after surgery.
• Similar trends, although with slightly better visual outcomes, were found in the subgroup of patients without other eye diseases.
• The mean final deviation from intended spherical equivalent was 0.77 ±1.19 D, representing a hyperopic shift.

Scientists reported that a combined procedure of cataract surgery, IOL implantation and DMEK-S is an effective method of treatment in patients with combined corneal disease and cataract to maintain long-term visual rehabilitation.

SOURCE: Studeny P, Hlozankova K, Krizova D, et al. Long-term results of a combined procedure of cataract surgery and Descemet membrane endothelial keratoplasty with stromal rim. Cornea 2021; May 1;40(5):628-34.


Computer-aided Detection & Abnormality Score for Outer Retinal Layer on OCT

Researchers developed a computer-aided detection (CAD) program of outer retinal layer (ORL) abnormalities in the retinal pigment epithelium, interdigitation zone and ellipsoid zone via optical coherence tomography.

In this retrospective study, healthy participants with normal ORL, and patients with ORL abnormality, including choroidal neovascularization or retinitis pigmentosa, were included. First, an automatic segmentation deep learning algorithm, the CAD, was developed for the three outer retinal layers using 120 handcraft masks of ORL. This automatic segmentation algorithm generated 4,000 segmentations, which included 2,000 images with normal ORL and 2,000 (1,000 CNV and 1,000 RP) images with focal or wide defects in ORL. Second, based on the automatically generated segmentation images, a binary classifier (normal vs. abnormal) was developed. Results were evaluated by area under the receiver operating characteristic curve.

Here are some of the findings:
• The DL algorithm achieved an AUC of 0.984 (CI, 0.976 to 0.993) for individual image evaluation in the internal test set of 797 images.
• The performance analysis of a publicly available external test set (n=968) had an AUC of 0.957 (CI, 0.944 to 0.970).
• A second clinical external test set (n=1,124) had an AUC of 0.978 (CI, 0.970 to 0.986).
• The CAD successfully highlighted normal areas of the ORL and omitted highlights in abnormal ORL areas indicating CNV and RP.

Researchers wrote that the CAD successfully used OCT images to segment the ORL and differentiate between normal and abnormal ORL areas. They added that the CAD classifier also performed visualization and may aid future physician diagnosis and clinical applications.

SOURCE: Rim TH, Lee AY, Ting DS, et al. Computer-aided detection and abnormality score for the outer retinal layer in optical coherence tomography. Br J Ophthalmol 2021 Apr 19. [Epub ahead of print.]




Industry News

Lumenis' Light Device FDA Approved for Treating Dry Eye

Lumenis announced that the FDA has granted De Novo authorization for the company's newest intense-pulsed-light device for improving the signs of dry eye due to meibomian gland dysfunction (MGD). Subsequent to the FDA approval, Lumenis is launching OptiLight. The company says OptiLight uses Lumenis’ patented Optimal Pulse Technology to "deliver a consistent, precise, and controlled light-based treatment of signs of dry-eye disease." Lumenis is hosting a virtual launch event for the OptiLight at 7 p.m. on May 13. To find out about the device and the event: click here.

New Ophthalmoscope Arrives

Hillrom says its new PanOptic Plus ophthalmoscope provides a viewing area that’s 20 times larger than the current Welch Allyn coaxial ophthalmoscope. The company says the new device features “Quick Eye Alignment” technology to help better direct a patient's gaze. Disc-alignment lights help the clinician direct and guide the patient's gaze, to help enable easier exams, Hillrom adds. Read more.

Alcon Launches Systane Hydration Multi-Dose Preservative-Free Lubricant Eye Drops, to Acquire U.S. Commercialization Rights to Simbrinza

Alcon announced the U.S. launch of the newest addition to its portfolio of dry-eye products – Systane Hydration Multi-Dose Preservative-Free Lubricant Eye Drops. With its proprietary HydroBoost Technology, this new preservative-free eye drop provides extra moisture for patients with sensitive dry eyes, the company says. Learn more.
In addition, the company signed an agreement to acquire exclusive U.S. commercialization rights to the glaucoma combination drug Simbrinza (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% from Novartis. Read more.


Genentech to Present New Data at ARVO Annual Meeting

Genentech is presenting new data at the annual Association of Research in Vision and Ophthalmology meeting, being held virtually May 1 to 7. Presentations include:
• an analysis of the release rate of ranibizumab from its late-stage Port Delivery System with ranibizumab (PDS) and potency over time;
• new data from the Phase III clinical trials of faricimab in neovascular age-related macular degeneration and diabetic macular edema; and
• a look at a personalized health-care program that may be needed to predict how often ranibizumab injections are needed in patients with DME during the initial dosing period for optimal long-term treatment of retinal vein occlusion, and a study on predicting geographic atrophy lesion growth through deep learning. In addition, several real-world studies will be presented on:
• new data on barriers to treatment adherence in nAMD and DME;
• long-term maintenance of driving vision for people with nAMD and DME following anti-VEGF treatment; and
• treatment patterns for nAMD patients following anti-VEGF therapy over five years.



Ocuphire Data to be Presented at ARVO Virtual Annual Meeting

Ocuphire Pharma says new data will be presented from PBPK modeling that confirmed the dosing strategy for the ongoing ZETA-1 Phase II trial in patients with diabetic retinopathy and diabetic macular edema. Read more.



Aerie Completes Enrollment of its Phase IIb Clinical Trial of AR-15512, Announces Presentations at the ARVO Annual Meeting

Aerie Pharmaceuticals completed patient enrollment for COMET-1, a Phase IIb clinical trial of AR-15512 (TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment of patients with dry eye. Read more.
In addition, the company will have poster presentations highlighting topics ranging from additional research findings on netarsudil to potential new product candidates. View the list of presentations.

Allegro to Present New Scientific Data at ARVO Annual Meeting

Allegro Ophthalmics announced that four scientific posters involving risuteganib, the company’s lead investigational compound in retina, will be presented during the virtual meeting. View the list of presentations.

B+L to Present New Scientific Data at ARVO Meeting

Bausch + Lomb will present new scientific data for several products across its pharmaceutical, surgical and vision care portfolios, as well as from the company’s ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) surveillance study. View the list of presentations.

Allergan to Share New Data at ARVO Annual Meeting

Allergan says it’ll present real-world evidence and patient-reported outcomes for products across its eye-care portfolio and pipeline at the virtual meeting. Learn more.

J&J Vision Introduces Acuvue Abiliti to Address Myopia in Children, Reinforces Sustainability Commitment

Johnson & Johnson Vision announced Acuvue Abiliti—a new brand for future products and services to help parents and eye-care providers address the growing prevalence and progression of myopia in children. Each annual purchase of an Abiliti product will provide a free comprehensive eye health exam to a child in need through Sight for Kids —a joint program from Johnson & Johnson Vision and the not-for-profit program from the Lions Clubs International Foundation. Read more.
In addition, the company signed a 10-year deal with JEA, a community-owned electric and water utility that serves Northeast Florida, to get 100 percent of its electricity for its global headquarters in Jacksonville, Fla., from solar power. Learn more.

Prevent Blindness Announces Recipients of Jenny Pomeroy Award, Declares May Ultraviolet Awareness Month

Prevent Blindness announced the recipient of the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health as R.V. Paul Chan, MD, MSc, MBA, FACS, professor and head of the Department of Ophthalmology and Visual Sciences at the University of Illinois at Chicago. Additionally, the group announced the recipient of the second annual Rising Visionary Award as Shervonne Poleon, Vision Science Graduate Program student, University of Alabama at Birmingham. Read more.
In addition, Prevent Blindness declared May Ultraviolet Awareness Month as a way to educate the public about the dangers of UV light. View the patient resources.

Heidelberg and RetInSight to Offer AI-based OCT Fluid Quantification

Heidelberg Engineering GmbH and RetInSight GmbH plan to interface RetInSight’s AI-based fluid monitor application with the Heidelberg Engineering product portfolio, using “cloud exchange and application marketplace technologies.” They hope the fluid monitor application will facilitate early diagnosis and therapeutic guidance in common retinal diseases. Read more.

Foundation Fighting Blindness Appoints Dr. Gelfman as Chief Scientific Officer

Foundation Fighting Blindness appointed Claire M. Gelfman, PhD, as chief scientific officer, with a focus on research initiatives designed to accelerate new treatments and cures for inherited retinal diseases. Prior to joining the Foundation, Dr. Gelfman served as vice president of pharmaceutical development at Adverum Biotechnologies. Read more.



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