Review of Ophthalmology Online



Vol. 22, #19  •   Monday, May 10, 2021


In this Issue:


Baseline Choroidal Microvasculature Dropout as a Predictor of OAG Progression

Researchers evaluated the impact of choroidal microvasculature dropout (CMvD), identified by optical coherence tomography angiography at baseline, on subsequent visual field progression in eyes with open-angle glaucoma.

This retrospective observational study included 80 OAG eyes with CMvD [CMvD(+)] and without CMvD [CMvD(-)] at baseline (40 of each matched for both age [≤10 y] and baseline VF severity [≤1 dB]). Subjects were followed regularly at six-month intervals. VF progression was defined according to the Early Manifest Glaucoma Trial criteria. The associations of overall VF progression with baseline clinical factors, including the presence of CMvD and other variables, were analyzed by logistic regression with a generalized estimating equation in the entire OAG cohort. Linear mixed models were used to determine the differences in VF mean sensitivity (VFMS) between the CMvD(+) and CMvD(-) groups globally and regionally at each follow-up point.

During a mean follow-up of 35.91 ±2.51 months, a significant difference was evident in the VF progression rate between the CMvD(-) and CMvD(+) groups (22.5 percent vs. 70 percent, p<0.001). CMvD at baseline and a higher visit-to-visit intraocular pressure fluctuation were significant predictors of VF progression. The VFMS differed significantly between the two groups in the central and superior central VF regions after two years of follow-up.

Researchers wrote that the presence of choroidal microvasculature dropout at baseline was an independent predictor of subsequent VF progression. Eyes with choroidal microvasculature dropout at baseline eyes showed a faster rate of VF mean sensitivity loss in the central and superior central VF region.

SOURCE: Jo YH, Shin JW, Song MK, et al. Baseline choroidal microvasculature dropout as a predictor of subsequent visual field progression in open-angle glaucoma. J Glaucoma 2021 Apr 15. [Epub ahead of print].




Choriocapillaris Flow Deficit & Development of Neovascularization or Atrophy in AMD

Investigators evaluated the relationship between choriocapillaris flow deficits and structural optical coherence tomography biomarkers, and the progression of intermediate age-related macular degeneration (iAMD) to complete retinal pigment epithelial and outer retinal atrophy (cRORA) or macular neovascularization (MNV).

Consecutive patients with iAMD were sequentially reviewed to define three equal-sized groups: progressed to MNV, progressed to cRORA or remained stable over 12 months of follow-up. Odds ratios for progression to cRORA and MNV were estimated by logistic regression for intraretinal hyperreflective foci (IHRF), hyporeflective drusen cores (hDC), subretinal drusenoid deposits (SDDs), high central drusen volume, fellow eye with late AMD, and peripheral and central choriocapillaris flow deficit.

Thirty iAMD eyes from 30 patients were enrolled into each group. Here are some of the findings:
• The choriocapillaris flow deficit was greater in the peripheral sectors of the macula of eyes which progressed to cRORA compared to the other two groups (p<0.0001).
• The central choriocapillaris flow deficit was also significantly impaired in eyes that progressed to cRORA or MNV compared to eyes that didn’t progress (p=0.001 and p=0.02, respectively).
• Choriocapillaris flow deficits in the peripheral macula were significantly and independently associated with the development of cRORA, while choriocapillaris flow deficits in the center were significantly and independently associated with the development of MNV.

Investigators wrote that while the choriocapillaris was diffusely impaired throughout the macula in intermediate AMD eyes that progressed to complete retinal pigment epithelial and outer retinal atrophy, it was relatively spared in the more peripheral macula among eyes that progressed to MNV. They suggested that these differential findings may have implications for the pathophysiology of the different late-stage manifestations of AMD.

SOURCE: Corvi F, Corradetti G, Tiosano L, et al. Topography of choriocapillaris flow deficit predicts development of neovascularization or atrophy in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2021; Apr 26. [Epub ahead of print].


How Time Outdoors and Patterns of Light Exposure impact Myopia in Children

Scientists looked at the association between reported time outdoors and light exposure patterns and myopia among 9-year-old children from the Growing Up in Singapore Towards Healthy Outcomes birth cohort.

Scientists assessed reported time outdoors (minutes/day), light exposure patterns and the outdoor activities of 9-year-old children (n=483), using a questionnaire, the FitSight watch and a seven-day activity diary. Light levels and the duration, timing and frequency of light exposure were assessed. Cycloplegic spherical equivalent (SE), myopia (SE ≤-0.5 D) and axial length (AL) of paired eyes were analyzed using generalized estimating equations.

In this study, 483 (966 eyes) children (50 percent boys, 59.8 percent of Chinese descent, 42.2 percent myopic) were included. Here are some of the findings:
• Reported time outdoors (mean ±SD) was 100 ±93 minutes/day, and average light levels were 458 ±228 lux.
• Of the total duration children spent at light levels ≥1,000 lux (37 ±19 minutes/day), 76 percent were spent below 5,000 lux.
• Peak light exposure occurred at mid-day.
• Children had 1.7 ±1 light exposure episodes/day.
• Common outdoor activities were walks, neighborhood play and swimming.
• Greater reported time outdoors was associated with lower odds of myopia (OR=0.82, CI 0.70 to 0.95/hour increase daily; p=0.009).
• Light levels, timing and frequency of light exposures weren’t associated with myopia, SE or AL (p>0.05).

Scientists wrote that reported time outdoors, light levels and number of light exposure episodes were low among 9-year-old Singaporean children. They added that reported time outdoors was protective against myopia, but not light levels or specific light measures. They recommend a multipronged approach to increase time outdoors in the combat against the myopia epidemic in children.

SOURCE: Li M, Lanca C, Tan CS, et al. Association of time outdoors and patterns of light exposure with myopia in children. Br J Ophthalmol 2021; Apr 15. [Epub ahead of print].


Higher Serum Uric Acid Levels and Risk of Vision-threatening DR

Researchers looked at the association between serum uric acid levels and vision-threatening diabetic retinopathy in patients with type 2 diabetes.

This cross-sectional study evaluated 3,481 patients with type 2 diabetes from four communities in China between 2016 and 2019. Vision-threatening DR was defined as severe nonproliferative or proliferative diabetic retinopathy, or clinically significant macular edema, evaluated by fundus photography and optical coherence tomography. Potential association between serum uric acid level and vision-threatening DR was examined using multivariable logistic regression. Subgroup analyses based on sex were constructed.

Here are some of the findings:
• A total of 305 participants had vision-threatening DR.
• Both higher serum uric acid level (OR, 1.22 per 100 µmol/L; CI, 1.04 to 1.44; p=0.013) and hyperuricemia (CI, 1.07 to 2.04; p=0.019) were positively associated with vision-threatening DR after adjustment for relevant covariates.
• Compared with those in the lowest SUA quartile, participants in the third (OR, 1.60; CI, 1.07 to 2.39; p=0.022) and fourth (OR, 2.05; CI, 1.37 to 3.08; p=0.001) sex-specific serum uric acid quartiles showed a significantly increased risk of vision-threatening DR after adjustment.
• No sex-related difference was observed.

Researchers found that higher serum uric acid levels were associated with an increased risk of vision-threatening DR in patients with type 2 diabetes in both sexes, although females seemed to be more sensitive to high serum uric acid levels than males. They suggest that prospective cohort studies will be needed to verify serum uric acid level as a biomarker for predicting the risk of vision-threatening DR, and that further research is needed to determine whether decreasing serum uric acid levels could decrease the risk of vision-threatening DR.

SOURCE: Hu Y, Chan Z, Li C, et al. Higher serum uric acid levels are associated with an increased risk of vision-threatening diabetic retinopathy in type 2 diabetes patients. Invest Ophthalmol Vis Sci 2021; Apr 1;62(4):23. [Epub ahead of print.]




Industry News

J&J Vision Announces Approval of Tecnis Synergy and Tecnis Synergy Toric II

Johnson & Johnson Vision announced the FDA approval of Tecnis Synergy and Tecnis Synergy Toric II IOLs. The company says the next-generation PCIOL, built on the legacy Tecnis platform, delivers the widest range of continuous vision with the best near vision among leading PCIOLs, superior contrast even in low-light conditions, and reduced spectacle wear. In a company-sponsored study, nine out of 10 patients who received TECNIS Synergy IOL lenses didn’t need glasses after surgery. Read for more information and references.

AGTC Reports Positive Data from Ongoing XLRP Trial

Applied Genetic Technologies, a biotechnology company conducting human clinical trials of adeno-associated virus-based gene therapies for the treatment of rare retinal diseases, reported additional positive data from the ongoing X-linked retinitis pigmentosa (XLRP) Phase I/II clinical trial. This included 12-month data from groups 5 and 6, reflecting a 50-percent response rate among patients who met the inclusion criteria for the Skyline and Vista trials, and 24-month data from two of three group-4 patients, providing preliminary evidence of response durability. The third patient was not a responder at month 12, and no early data are available for the remaining four group-4 patients. Read more.

Novartis Phase III Beovu Data Show Potential for Fluid Resolution

Novartis announced positive one-year results of the Phase III KESTREL and KITE studies, evaluating the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema. Both studies met their primary endpoints of non-inferiority in change in best-corrected visual acuity from baseline for Beovu 6 mg vs. aflibercept 2 mg at year one. Read more.


OpRegen Demonstrates Improvements in Patients with Dry AMD with GA

Lineage Cell Therapeutics announced that updated interim results from its Phase I/IIa clinical study of lead product candidate OpRegen were reported at the Association for Research in Vision and Ophthalmology annual meeting, held virtually May 1 to 7. Data were presented on 24 patients, including all 12 treated in cohort 4, which showed better baseline vision and smaller areas of GA than earlier cohorts. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space for the treatment of dry age-related macular degeneration with geographic atrophy. Read more.



OWL Announces Development and Networking Program for Executives

Ophthalmic World Leaders, an organization dedicated to promoting and developing diverse leadership to advance ophthalmic innovation and patient care, announced its inaugural Get-On-Board with OWL program. Primarily aimed at executive-level women and underrepresented communities, this offering will help attendees develop the skills and connections required to secure board positions in a rapidly changing corporate environment. Learn more and register.

FDA Analysis of Endophthalmitis Rates with ReSure Sealant

Ocular Therapeutix received notification from the FDA confirming it fulfilled all post-approval study requirements for ReSure Sealant, with a requirement to update the ReSure label reflecting the study results. As a condition for ReSure’s pre-market approval application in 2014, the FDA required two post-approval studies to be completed. Read more.

Refractive Surgery Council Reports Nearly 30 Percent Rise in Laser Vision Correction Procedures

The Refractive Surgery Council, which helps consumers make informed choices about their vision correction options, reported that the start of 2021 had a nearly 30 percent rise in laser vision correction procedures over 2020. More than 220,000 LASIK, SMILE and PRK procedures have been performed so far this year, reflecting demand fueled by a renewed consumer focus on self-care and safety. Learn more about the Council.

Verana Leads Study Showing Promise of Real-world Data in Ophthalmic Clinical Development

Verana Health unveiled research during the virtual Association for Research in Vision and Ophthalmology Annual Meeting demonstrating it was able to successfully use real-world data to replicate primary outcome measures of two large-scale randomized controlled trials in ophthalmology—the VIEW 1 and VIEW 2 pivotal trials. Read more.

J&J Vision Presents New Data at ARVO Annual Meeting

Johnson & Johnson Vision presented nearly 30 posters and papers of research data on myopia, intraocular lenses, phacoemulsification, refractive surgery and meibomian gland dysfunction at the virtual Association for Research in Vision and Ophthalmology Annual Meeting held from May 1 to 7. View a list of the presentations.



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