Review of Ophthalmology Online


Volume 18, Number 41
Monday, October 8, 2018


In this issue: (click heading to view article)
######### Mediterranean Diet Helps Prevent Advanced AMD
######### Dark Adaptation as a Functional Outcome Measure for AMD
######### Bevacizumab Dosing Every Two Weeks for Recalcitrant nAMD
######### AS-OCT for Corneal Imaging With Flap-Related Complications Post-LASIK
######### SLT vs. ALT in Glaucoma Cases Previously Treated With 360-degree SLT


Mediterranean Diet Prevents Leading Cause of Blindness

Researchers from the European Union investigating the connection between genes and lifestyle on development of age-related macular degeneration found that people who adhered to a Mediterranean diet (abbreviated as MeDi in the study) can cut their risk of late-stage AMD significantly.

The study was a prospective cohort study of 4,446 participants age 55 and older in the Rotterdam Study-I and 550 adults over age 72 from the Antioxidants, Lipides Essentiels, Nutrition et Maladies Oculaires (ALIENOR) study. The researchers examined Rotterdam Study patients every five years for 21 years and ALIENOR patients every two years over just a four-year period. Adherence to the MeDi was evaluated using a 9-component score based on intake of vegetables, fruits, legumes, cereals, fish, meat, dairy products, alcohol, and the monounsaturated-to-saturated fatty acids ratio.

Among the 4,996 participants, 155 developed advanced incident AMD (117 from the RS-I and 38 from the ALIENOR). The mean follow-up time was 9.9 years in the RS-I and 4.1 years in the ALIENOR study. Pooling data for both the RS-I and ALIENOR, participants with a high (range: 6–9) MeDi score showed a significantly reduced risk for incident advanced AMD compared with participants with a low (range, 0–3) MeDi score. Specifically, a higher adherence to the MeDi was associated with a 41 percent reduced risk of advanced AMD.

SOURCE: Merle BM, Colijn JM, Cougnard-Gregoire A, et al, for the EYE-RISK Consortium. Mediterranean diet and incidence of advanced age-related macular degeneration. Ophthalmology 2018 (in press).

Dark Adaptation as a Functional Outcome Measure for AMD

Researchers investigated the natural history of dark adaptation function, as measured by the change in rod intercept time (RIT) over four years, and correlated RIT changes with age-related macular degeneration severity, as part of a longitudinal, single-center, observational study.

Participants included 77 individuals ≥50 years of age with a range of AMD severities. Subjects were assigned into AMD severity groups based on fundus characteristics (drusen, pigmentary changes, late AMD and subretinal drusenoid deposits). Researchers assessed DA function in study eyes at baseline, three, six, 12, 18, 24, 36 and 48 months. They calculated mean change in DA function over time using the slope of linear regression fits of longitudinal RIT data. Subject-reported responses on a low-luminance questionnaire were obtained at baseline and yearly. Nonparametric statistical testing was performed on all comparisons.

Researchers monitored RIT—defined as the time taken following a photobleach for visual sensitivity to recover detection of a 5 cd/m2 x 10-3 cd/m2 stimulus (a decrease of 3 log units)—in study eyes over four years and computed the mean rate of change.

Longitudinal analysis of 65 study eyes followed on the standard testing protocol (mean age: 71 ±9.3 years; 49 percent female) revealed that higher rates of RIT prolongation were correlated with AMD severity group assignment at baseline (p=0.026) and at year four (p=0.0011). Study eyes that developed subretinal drusenoid deposits during follow-up demonstrated higher rates of RIT prolongation than those that didn’t (p<0.0001). Overall, higher rates of RIT prolongation were significantly correlated with greater four-year decreases in low-luminance questionnaire scores (total mean score, p=0.0032).

Researchers determined that longitudinal decline in DA function, which correlated with subject-reported functional deficits, was accelerated in eyes with greater AMD severity and in those with subretinal drusenoid deposits at baseline and four years.

SOURCE: Chen KG, Alvarez JA, Yazdanie M, et al. Longitudinal study of dark adaptation as a functional outcome measure for age-related macular degeneration. Ophthalmology 2018; Sep 29. [Epub ahead of print].

Bevacizumab Dosing Every Two Weeks for Recalcitrant nAMD

Investigators evaluated intravitreal bevacizumab every two weeks in refractory neovascular age-related macular degeneration as part of a retrospective study of consecutive individuals with nAMD unresponsive to monthly intravitreal anti-vascular endothelial growth factor switched to three to four biweekly injections.

Twenty-seven eyes of individuals ages 82.08  ±6.85 were included. Prior to the two-week interval bevacizumab injections, 74.1 percent (n=20) were treated with bevacizumab and ranibizumab, 11.1 percent (three eyes) also received aflibercept and 14.8 percent (four eyes) had prior treatment of monthly bevacizumab (average number of injections 21.5 ±6.7).

  • Best-corrected visual acuity remained stable between baseline (logMAR 0.72 ±0.60) and follow-up (0.76 ±0.66) (p=0.41).
  • Mean central macular thickness and macular volume didn’t change significantly between baseline (p=0.35) and follow-up (p=0.60).
  • Six eyes (22.2 percent) showed morphologic anatomic improvements, while 19 eyes (70.4 percent) were stable and two eyes (7.4 percent) deteriorated from baseline.
  • Subretinal fluid completely resolved in three eyes and improved in the other three eyes; in the latter eyes (22.2 percent) central macular thickness (326.2 ±101.4 vs. 297.5 ±97.2, p=0.002) and macular volume (8.69 ±1.69 vs. 8.22 ±1.43, p=0.03) were significantly reduced.
  • No adverse events were observed in any treated eyes.

The study demonstrated that biweekly bevacizumab injections were effective in nearly one-quarter of nAMD non-responders, with no adverse events reported. Investigators found that switching earlier, rather than later, to the low-cost modality might be of benefit for some non-responders to conventional treatment.

SOURCE: Mimouni M, Meshi A, Vainer I, et al. Bevacizumab dosing every 2 weeks for neovascular age-related macular degeneration refractory to monthly dosing. JJO 2018; Sept. 29. [Epub ahead of print].

AS-OCT for Corneal Imaging With Flap-related Complications Post-LASIK

Scientists assessed the role of swept-source anterior segment optical coherence tomography in the diagnosis and management of laser in situ keratomileusis flap-related complications.

The prospective study included 25 eyes with LASIK flap-related complications that were imaged using swept-source AS-OCT between February and August 2016, at Alforsan Eye Centre, Assiut, Egypt. The images were acquired using a 6-mm line scan.

Imaging flap-related LASIK complications using AS-OCT revealed specific and nonspecific findings:

  • Epithelial ingrowth appeared as highly reflective lesions below the LASIK flap in the form of islands, nests or a continuous sheet, with or without changes in the overlying flap.
  • Macrostriae manifested as dome-shaped irregularities on the stromal surface with regular overlying epithelium, whereas microstriae appeared as corrugations on the stromal surface with regular overlying epithelium.
  • Less-common complications included multiple flap macrostriae accompanied by a traumatic folded flap with a flap edge at the interface.
  • Interface debris appeared as a highly reflective interface lesion with or without a surrounding reaction.
  • One eye with a flap that was torn and lost intraoperatively showed epithelialization over a thin residual stroma underlying a contact lens with no stromal infiltration on the second postoperative day.

Scientists wrote that AS-OCT was useful for the assessment of flap thickness and planning of the new flap thickness in the event of an incomplete cut. They added that it was useful for diagnosis and management of eyes with LASIK flap-related complications by enabling noninvasive, noncontact, real-time acquisition of cross-sectional AS images.

SOURCE: Abdelazeem K, Mohamed S, Mohamed SGA, et al. Relevance of swept-source anterior segment optical coherence tomography for corneal imaging in patients with flap-related complications after LASIK. Cornea 2018; Sep 27. [Epub ahead of print].


SLT vs. ALT in Glaucoma Cases Previously Treated With 360-degree SLT

Researchers evaluated the effectiveness of selective laser trabeculoplasty compared with argon laser trabeculoplasty in a randomized clinical trial for individuals with medically uncontrolled open-angle glaucoma who previously received 360 degree SLT.

In an active-equivalence, parallel-armed, randomized control trial, subjects with OAG including pigmentary dispersion syndrome and pseudoexfoliation syndrome were enrolled from seven sites across Canada. One setting of 180 degrees of either SLT or ALT was assigned randomly and applied to each participant. Main outcome measures included the change in intraocular pressure from baseline to 12 months.

A total of 130 individuals completed the study per the protocol. The IOP decrease at one year compared with baseline for SLT vs. ALT was found to be different by 0.33 mmHg among the two groups (3.16 for SLT and 2.83 for ALT) and wasn’t statistically significant (p=0.71). Further analysis showed that SLT had a significantly lower IOP reduction at early time points—one week and one month, but this effect was lost by three months. Corresponding with this finding was the strong trend for ALT to fail more quickly than SLT. Although repeatable, the first repeat SLT reduced IOP to about half compared with initial SLT treatments.

Researchers found that the 12 month-comparison following laser therapy revealed that both modalities lowered the IOP by approximately 3 mmHg, yet essentially all time-to-failure analyses favored SLT over ALT; the repeat SLT effect was found to be half of the initial treatment.

SOURCE: Hutnik C, Crichton A, Ford B, et al. SLT versus ALT in glaucoma patients treated previously with 360-degree slt: A randomized, single-blind, equivalence clinical trial. Ophthalmology. 2018; Sep 29. [Epub ahead of print].

  • Eyevance Acquires Worldwide Rights to Nexagon
    Eyevance Pharmaceuticals announced a worldwide licensing agreement with OcuNexus Therapeutics for Nexagon, a 30-base antisense oligomer being developed for the orphan indication of persistent corneal epithelial defect nonresponsive to standard of care. The company says the first-in-class unmodified antisense oligodeoxynucleotide inhibits a cell membrane hemichannel-forming protein, connexin43 overexpression and the inflammatory cascade. Read more.


  • Omeros Announces Reinstatement of Pass-through Status for Omidria
    Omeros announced that reinstatement of separate payment by the Centers for Medicare and Medicaid Services under the pass-through program for the company’s cataract surgery drug Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is effective. Omidria received a two-year extension of pass-through reimbursement status as a result of a Congressional response to nationwide concerns regarding limited access for Medicare beneficiaries to this and several other drugs due to inadequate reimbursement when payments are packaged into respective procedural fees. Read more.

  • Eyenuk With EyeArt AI Eye Screening for DR Expands Into Germany
    Eyenuk expanded into Germany with the adoption of EyeArt artificial intelligence technology for the screening of diabetic retinopathy at Diabetes Center Mergentheim in Bad Mergentheim, Germany. The AI system autonomously reads retinal images and screens for diabetic retinopathy in under 60 seconds. In the United States, the EyeArt system is limited to investigational use only. Read more.

  • Genentech/Roche Initiate Phase III Trials for Novel Wet AMD & DME Treatments
    Genentech and Roche initiated three large Phase III clinical trials investigating the Port Delivery System with ranibizumab in wet age-related macular degeneration and faricimab (formerly RG7716) in diabetic macular edema. The PDS is a first-of-its-kind refillable eye implant designed to continuously release a special formulation of ranibizumab over a period of months. Faricimab is the first bispecific antibody designed for the treatment of retinal eye diseases that simultaneously binds to and inactivates vascular endothelial growth factor A and Angiopoietin-2. By targeting both VEGF-A and Ang-2, faricimab may lead to improved outcomes and/or reduced treatment burden.

  • TruForm Offers Dry Eye & OSD Management with DigiForm Scleral
    TruForm Optics announced the therapeutic use of its DigiForm Scleral contact lens through the company’s strategic partnership with Contamac, which received FDA 510(k) clearance for Optimum Extra and Optimum Extreme contact lens materials to treat dry-eye conditions. The materials are suitable for therapeutic use in eyes with ocular surface disease, limbal stem cell deficiency, neurotrophic keratitis and corneal exposure, in which the expanded tear reservoir and protection against an adverse environment afforded by a scleral lens might prove beneficial.

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