Review of Ophthalmology Online



Vol. 22, #20  •   Monday, May 17, 2021


In this Issue:


Detecting Progression of Different VF Patterns

Researchers compared the variability and ability to detect visual field progression of 24-2, and 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 years of follow-up were included.

Linear regression models were used to calculate the rates of mean deviation change (slopes) while their residuals helped assess variability across the entire MD range. Computer simulations (n=10,000) based on real MD residuals of the sample were performed to estimate power to detect significant progression (p<5 percent) at various rates of MD change. The main outcome measure was 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 than 24-2 or central 24-2.
• Overall, 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 to 26.5 percent when compared to central 24-2.

Researchers found that time to detect central VF progression was reduced with 10-2 MD compared with 24-2 and central 24-2 MD in glaucoma eyes in part because 10-2 tests had lower variability. They added that the findings contribute to evidence of 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; Apr 10. [Epub ahead of print].




T&E Regimen with Aflibercept for BRVO: 1-Year Results of PLATON

Investigators evaluated the functional and anatomical outcomes of a treat-and-extend regimen with aflibercept for treatment-naive macular edema secondary to branch retinal vein occlusion.

This prospective, multicenter, noncomparative open-label clinical trial included 48 eyes of 48 patients who received three monthly intravitreal aflibercept injections prior to the T&E regimen. However, if the best-corrected visual acuity was ≥20/20 and the central macular thickness was <250 μm during the loading phase, the patient immediately proceeded to the T&E regimen. The treatment interval was adjusted by four weeks based on changes in CMT. The primary outcome was the mean change in BCVA from baseline to 52 weeks.

Here were some of the findings:
• The mean change in BCVA was 23.6 ±14.2 letters.
• The proportion of patients with BCVA gain ≥15 letters was 77.1 percent at 24 weeks and 72.9 percent at 52 weeks.
• The mean reduction in CMT was 326.2 ±235.6 μm at 24 weeks and 324.2 ±238 μm at 52 weeks.
• The mean number of injections was 6.7 ±1.2 (range, 6 to 11; all patients received three monthly intravitreal aflibercept injections) over 52 weeks, and 34 patients (70.8 percent) reached the maximal extension interval of 16 weeks at 52 weeks.

Investigators found that the T&E regimen using aflibercept for ME secondary to BRVO, which has a treatment interval of up to 16 weeks, showed comparable efficacy to the fixed-dosing regimen along with reduced treatment burden.

SOURCE: Park DG, Jeong WJ, Park JM, et al. Prospective trial of treat-and-extend regimen with aflibercept for branch retinal vein occlusion: 1-year results of the PLATON trial. Graefes Arch Clin Exp Ophthalmol 2021; Apr 29. [Epub ahead of print].


Complimentary CME Education Videos


Bowman’s Layer Onlay Grafting

Scientists aimed to describe a new surgical technique for flattening the corneal curvature and to reduce progression in eyes with advanced progressive keratoconus (KC) by using Bowman’s layer (BL) onlay grafting.

In this prospective interventional case series, five patients with advanced progressive KC underwent BL onlay grafting. After removal of the epithelium, a BL graft was placed and “stretched” onto the stroma, and a bandage lens was placed to cover the BL graft. In one case, BL onlay grafting could be performed immediately after ultraviolet corneal crosslinking; all other eyes were ineligible for ultraviolet corneal crosslinking. Best spectacle- and/or best contact lens-corrected visual acuity, refraction, biomicroscopy, corneal tomography, anterior segment optical coherence tomography and complications were recorded at one week; and at one, three, six, nine, and 12 to 15 months postoperatively.

All five surgeries could be performed successfully. Average maximum keratometry went from 75 D preoperatively to 70 D at one year postoperatively. All eyes showed a completely re-epithelialized and well-integrated graft. Best spectacle-corrected visual acuity improved by at least two Snellen lines (or more) in three of five cases, and best contact lens-corrected visual acuity remained stable, improving by three Snellen lines in case one at 15 months postoperatively. Satisfaction was high, and all eyes again had full contact lens tolerance.

Scientists determined that BL onlay grafting may be a feasible surgical technique, providing up to -5 D of corneal flattening in eyes with advanced KC.

SOURCE: Dapena I, van der Star L, Groeneveld-van Beek EA, et al. Bowman Layer Onlay Grafting. Cornea 2021; April 14. [Epub ahead of print.]


NIH Study Affirms AREDS2 Results

Researchers from the National Eye Institute performed a 10-year follow-on study of the Age-Related Eye Disease Study 2, and found that the results confirm those of the original, five-year study. They shared their results at the recent meeting of the Association for Research in Vision and Ophthalmology.

The AREDS2 clinical trial randomly assigned participants with bilateral intermediate AMD or late AMD in one eye to lutein/zeaxanthin and/or omega-3 fatty acids or placebo. Secondary randomization also evaluated varying doses of beta-carotene (0 vs. 15 mg) and zinc (25 vs. 80 mg). At the end of the clinical trial, a follow-up study was conducted with telephone calls every six months to the surviving AREDS2 participants from the central coordinating center to collect outcome data and adverse events for safety monitoring for an additional five years.

In the study, 6,360 eyes (3,887 patients) were analyzed and 3,047 (48 percent) progressed to late AMD. The main effects of lutein/zeaxanthin vs. no lutein-zeaxanthin and of omega-3 fatty acids vs. no omega-3 fatty acids resulted in hazard ratios of 0.91 (95% CI: 0.89-0.99) (p=0.03) and 1.00 (0.92-1.09) (p=0.91), respectively. When the lutein/zeaxanthin main effect analysis was restricted to those randomized secondarily to beta-carotene, the HR was 0.80 (0.69-92) (p=0.003).

On direct analysis of lutein/zeaxanthin vs. beta-carotene, the HR was 0.85 (0.74-0.98) (p=0.026). For the comparisons of low vs. high zinc and no beta-carotene vs. beta-carotene, the HRs were 1.04 (p=0.48) and 1.04 (p=0.50), respectively. For those randomized to beta-carotene, the odds ratio (OR) of developing lung cancer was 1.92 (1.11-3.31)(p=0.02) while the OR for those randomized to lutein/zeaxanthin was 1.19 (0.82-1.73) (p=0.35).

The researchers say that, again, they showed that lutein/zeaxanthin was safer than using beta-carotene, as the latter was found to double the chance of lung cancer. They say the use of lutein/zeaxanthin showed a more favorable response when compared with beta-carotene.

SOURCE: Chew EY , Clemons TE, Keenan TD, et al. The results of the 10 year follow-on study of the age-related eye disease study 2 (AREDS2). Presented at the 2021 ARVO Annual Meeting.


Dilated Choroidal Veins & Myopic Macular Neovascularization Recurrence

Researchers looked at a possible correlation between the presence of macular dilated choroidal vein (DCV) and the recurrence of myopic macular neovascularization (MNV) after anti-vascular endothelial growth factor treatment.

The medical records of 168 eyes of 163 patients with myopic MNV were reviewed for the presence of macular DCV and episodes of recurrences. A macular DCV was defined as a choroidal vein whose diameter was two times larger than the adjacent veins coursing in the macular area of 5.5 mm diameter.

• Macular DCV existed in 47 eyes (28 percent) with myopic MNV.
• Seventy eyes (41.7 percent) had recurrence during a mean follow-up period of 52.5 ±23 months.
• Recurrence was found in 28 of 47 eyes (59.6 percent) with DCV, which was significantly more frequent than in the 42 of the 121 eyes (34.7 percent) without DCV (p=0.003).
• Cox model analysis showed that macular DCV was an independent risk factor (HR, 2; CI, 1.1 to 3.5) for recurrence.
• The recurrence rate was significantly higher in eyes with DCV within the first two years after the onset than in eyes without DCV.

Researchers concluded that macular DCVs may be indicators of a more aggressive phenotype of eyes with myopic MNV. They suggested that these eyes need careful monitoring after anti-VEGF therapies.

SOURCE: Xie S, Du R, Fang Y, et al. Dilated choroidal veins and their role in recurrences of myopic macular neovascularisations. Br J Ophthalmol 2021; Apr 28. [Epub ahead of print].




Industry News

J&J Vision Announces FDA Approval of Acuvue Abiliti Overnight Therapeutic Lenses for Myopia Management

Johnson & Johnson Vision announced the FDA approved Acuvue Abiliti Overnight Therapeutic Lenses. The company says this is the first and only FDA approved orthokeratology (ortho-k) contact lens for the management of myopia. Abiliti Overnight ortho-k contact lenses are specifically designed and fitted to match the eye based on its corneal shape to temporarily reshape the cornea. Abiliti Overnight will be available for astigmatic eyes, as well. Read more.

Gemini Completes Enrollment in Phase IIa Study of GEM103

Gemini Therapeutics completed enrollment in its Phase IIa trial advancing GEM103 as a potential add-on therapy for patients with wet age-related macular degeneration requiring continued anti-vascular endothelial growth factor treatment, who have—or may be at risk for—macular atrophy. Topline data related to safety, tolerability, effect on intraocular complement factor H levels and disease-relevant biomarkers of complement regulation is expected in late 2021. Read more.

ProtoKinetix and IQVIA Partner to Develop AAGP

ProtoKinetix announced its collaboration with IQVIA to accelerate development of AAGP (PKX-001) in ocular conditions, specifically dry-eye disease, and wet and dry forms of age-related macular degeneration. PKX-001 is entering clinical trials to determine safety in these conditions, drawing from previous experience with PKX-001 in type 1 diabetes and other conditions. Read more.


Euclid Introduces Euclid MAX Ortho-K Lens

Euclid Systems announced the U.S. launch of Euclid MAX for overnight orthokeratology. Euclid will host two live roundtable discussions focused on the lens with top ortho-k practitioners. “Shifting the Paradigm: Maximize Performance with the Next Generation of Ortho-K Lenses” will be held May 19 and 20. For more details and to register click here.



Alcon Partners with BlephEx

Alcon announced an agreement that provides Alcon exclusive rights to sell BlephEx technology and accompanying products in the United States. The partnership with BlephEx, a device and eyelid cleaning procedure removing excess bacteria and biofilm, means the BlephEx eyelid cleaning device and LashCam iR WIFI camera will join Alcon’s Systane iLux technology to help meet the in-office, ocular surface health needs of patients, Alcon says. Read more.






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