From the editors of Review of Ophthalmology:
JANUARY IS GLAUCOMA AWARENESS MONTH
In this issue: (click heading to view article)
Effect of MMC and Bevacizumab-methylcellulose on Combined Phaco & Non-penetrating Deep Sclerectomy Surgery on IOP
Researchers compared the effect of mitomycin C vs. a bevacizumab-methylcellulose mixture on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure of individuals with open-angle glaucoma, as part of a controlled, randomized, double-blind clinical trial.
Thirty-eight individuals (40 eyes) were enrolled and underwent a combined phacoemulsification and non-penetrating deep sclerectomy surgery between 2016 and 2017. MMC with concentration of 0.2 mg/mL for two minutes was used for 20 eyes before separating the scleral flap, and 0.3 mL of BMM (bevacizumab 1.25 mg incorporated into 2% methylcellulose) was injected subconjunctivally following surgery. The success rate of surgery was categorized as complete, relative or failure. Fisher’s exact, Mann-Whitney U and Chi-square tests were employed to data analysis. A p-value <0.05 was considered significant.
Individuals had the same distribution in terms of age, sex, type of glaucoma and type of cataract. They were followed up for a mean of six months. Here are some of the findings:
• The mean IOP before surgery in the MMC group was 24.85 ±2.83 mmHg with 3.2 ±0.523 anti-glaucoma drugs, which reached 13.75 ±3.552 mmHg with 0.15 ±0.489 anti-glaucoma drugs at the latest visit.
• The average IOP before surgery in the BMM group was 24.45 ±2.48 mmHg with 2.9 ±0.641 anti-glaucoma drugs, which reached 15.40 ±3.267 mmHg with 0.25 ±0.55 anti-glaucoma drug at the last follow-up.
• IOP was notably lower in the MMC than BMM group six months after surgery.
• Researchers found no significant differences in success and failure rates between the two groups at the six-month follow-up (p=0.135).
Researchers wrote that MMC and bevacizumab-methylcellulose appeared to be effective for the success of combined phacoemulsification and non-penetrating deep sclerectomy surgery, but that MMC decreased IOP in individuals at six months post-surgery.
SOURCE: Mostafaei A, Taheri N, Ghojazadeh M, et al. Comparison of the effect of mitomycin C and bevacizumab-methylcellulose mixture on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure (a clinical trial study). Int Ophthalmol 2019; Jan 17. [Epub ahead of print].
En Face OCTA Averaging vs. Single-image Quantitative Measurements for RVO Visual Outcomes
Investigators demonstrated the effect of averaging multiple en face optical coherence tomography angiography images on the correlation between retinal microvasculature quantitative metrics and best-corrected visual acuity in eyes with retinal vein occlusion.
A cross-sectional cohort with unilateral retinal vein occlusion in both eyes was imaged. Investigators averaged five 3 mm × 3 mm spectral-domain OCTA images, and correlated quantitative parameters from averaged vs. single images with logMAR BCVA. They performed regression analyses to correlate quantitative metrics with BCVA. Ten individuals (five males; average age: 64.3 years) were included. The following were some of the results:
• Among retinal vein occlusion eyes, vessel length density was significantly less in averaged vs. single images for the superficial retinal layer (15.5 ±2.5/mm vs. 17.8 ±2.4/mm; p=0.05) and deep retinal layer (16.2 ±1.4/mm vs. 18.5 ±1.6/mm; p=0.003).
• Multivariate linear regression showed an increased R2 value with averaging (0.93 for single and 0.95 for averaged groups).
• Foveal avascular zone circularity was associated with BCVA on single images (coefficient=-0.96; p=0.002), but not with averaged images (p=0.063).
Investigators concluded that scan averaging of en face OCTA images improved the clarity of vessels and might allow for more accurate quantification of vessel metrics. They added that quantitative metrics were significantly associated with BCVA, and averaging didn’t further improve this association compared with single-scan analysis.
SOURCE: Jung JJ, Chen MH, Shi Y, et al. Correlation of en face optical coherence tomography angiography averaging versus single-image quantitative measurements with retinal vein occlusion visual outcomes. Retina 2018; Jan. 22. [Epub ahead of print].
Posterior Corneal Elevation & Biomechanics After SMILE and LASEK for Myopia
Scientists compared the posterior corneal elevation and corneal biomechanics after small incision lenticule extraction and laser-assisted subepithelial keratomileusis for myopia correction in a short- and long-term observation.
The prospective study included 32 individuals in the SMILE group and 32 people in the LASEK group. Corneal posterior central elevation, posterior mean elevation, corneal back power (Kb) and anterior chamber depth were evaluated with the Oculus Pentacam. Intraocular pressure, corneal hysteresis and corneal resistance factor were evaluated with the Reichert Ocular Response Analyzer pre-surgery, and three months and three years post-surgery. Below are some of the findings:
• Three months postoperatively, CH, CRF and IOP decreased significantly, and central posterior surface shifted backward in both groups (p<0.05).
• CH was lower in the LASEK group (p=0.03), and change of CH and CRF per-unit corneal tissue removed (∆CH/ablation depth and ∆CRF/AD) was lower in SMILE than in LASEK (p=0.01, 0.03).
• Three years postoperatively, the PME shifted more posteriorly in LASEK (p=0.04), but was stable in SMILE (p=0.06). Kb flattened and ACD was shallower in both groups (compared to preoperative data, p<0.001).
• CH in the LASEK group increased and was comparable to that in the SMILE group at three years postoperatively.
Scientists found that SMILE and LASEK could change the posterior surface and corneal biomechanics. They wrote that SMILE might have less influence on corneal biomechanics than LASEK at an early stage postoperatively in terms of per-unit corneal tissue removed, but that the effect became comparable in a long-term observation.
SOURCE: Yu M, Chen M, Dai J, et al. Comparison of the posterior corneal elevation and biomechanics after SMILE and LASEK for myopia: a short- and long-term observation. Graefes Arch Clin Exp Ophthalmol 2019; Jan 14. [Epub ahead of print].
Treat-and-extend Trial with Ranibizumab in nAMD: CANTREAT Study
Researchers compared the efficacy of ranibizumab using a treat-and-extend regimen to monthly dosing in treatment-naïve subjects with neovascular age-related macular degeneration, as part of a prospective, randomized, open-label, multicenter, non-inferiority, post-authorization study.
Participants included treatment-naïve subjects with choroidal neovascularization secondary to AMD. Subjects with nAMD were randomized 1:1 to receive intravitreal ranibizumab at a dose of 0.5 mg in a T&E or monthly dosing regimen. The non-inferiority of T&E compared with the monthly dosing regimen was shown using a margin of five letters in best-corrected visual acuity improvement.
The main outcome measure was mean change in BCVA Early Treatment Diabetic Retinopathy Study from baseline to month 12. Baseline and 12-month visual acuity data were available for 526 individuals (T&E: n=268; monthly: n=258). Below are some of the results:
• At baseline, mean age was 78.8 ±7.8 years: 60.3 percent were females and 94.3 percent were Caucasian. No significant between-group baseline differences were observed.
• The primary outcome of non-inferiority regarding visual acuity was met with mean BCVA improvement of 8.4 ±11.9 letters in the T&E group and 6 ±11.9 letters in the monthly group (p=0.017), with a between-group mean difference of 2.38 (CI, 0.32 to 4.45).
• Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E (9.4) vs. monthly (11.8) dosing, with a mean difference of -2.46 (CI, -2.68 to -2.23).
Researchers determined that 12-month results of the two-year study revealed that, with regard to visual outcomes, the T&E regimen was non-inferior to a monthly dosing regimen. They added that similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections.
SOURCE: Kertes PJ, Galic IJ, Greve M, et al. Canadian treat and extend analysis trial with ranibizumab in patients with neovascular age-related macular disease: 1-year results of the randomized CANTREAT study. Ophthalmology 2019; Jan 21. [Epub ahead of print].
Bruder Announces Eyeleve Contact Lens Compress
Bruder Healthcare announced the availability of Eyeleve, the first contact lens compress designed to increase comfortable contact lens wear time by up to three hours daily. The compress is intended to deliver consistent, therapeutic moist heat to alleviate symptoms of meibomian gland dysfunction and contact lens-related dry eye. By stimulating glands and increasing oil production, the compress helps stabilize the ocular surface to reduce dryness and extend comfortable wear time of contacts. Bruder collaborated on a trial with clinicians at the University of Alabama-Birmingham that found that subjects using Bruder masks with MediBeads technology had significantly improved meibomian gland scores and experienced steeper declines in their overall Eye Discomfort Assessment scores. Read more.
Aerpio Completes Patient Dosing in TIME-IIb Study of AKB-9778 in DR
Aerpio Pharmaceuticals finished patient dosing in the company’s TIME-IIb study, a clinical trial designed to assess the efficacy and safety of the company’s lead candidate, AKB-9778, for individuals with moderate to severe non-proliferative diabetic retinopathy. The double-masked, placebo-controlled, multicenter trial is evaluating the effect of AKB-9778 in 167 subjects with moderate to severe NPDR. Individuals were randomized to receive 48 weeks of treatment with AKB-9778 15 mg subcutaneously once daily (and placebo subcutaneously once daily), AKB-9778 15 mg subcutaneously twice daily or placebo subcutaneously twice daily. The primary endpoint is the percentage of individuals who improve by two or more steps in diabetic retinopathy severity score in the study eye. Read more.
Optovue Names Garibaldi VP of U.S. Sales
Optovue announced the promotion of Joe Garibaldi to vice president of U.S. Sales. Garibaldi, who joined the company in 2009 as a territory manager, has been promoted into multiple leadership positions within the sales organization where he has led sales growth in the optometry and ophthalmology markets. In recent years, Garibaldi expanded the Optovue sales organization to commercialize the AngioVue OCT Angiography imaging system.
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