From the editors of Review of Ophthalmology:
AUGUST IS CHILDREN’S EYE HEALTH/SAFETY MONTH
In this issue: (click heading to view article)
Choriocapillaris Impairment in Eyes with CNV Secondary to AMD
Researchers developed an optical coherence tomography angiography-based framework for quantitatively analyzing the spatial distribution of choriocapillaris (CC) impairment around choroidal neovascularization secondary to age-related macular degeneration.
In a retrospective, cross-sectional study, they quantitatively analyzed 400-kHz swept-source OCTA images from seven eyes of six individuals with CNV secondary to AMD using custom software. Researchers developed a lesion-centered zonal OCTA analysis technique, which portioned the field-of-view into zones relative to CNV boundaries, to quantify the spatial dependence of CC flow deficits.
Quantitative, lesion-centered zonal analysis of CC OCTA images revealed the highest flow-deficit percentages near CNV boundaries, decreasing in zones farther from the boundaries. OCTA using shorter interscan times (1.5 ms) revealed more severe flow deficits than OCTA using longer interscan times (3 ms); however, spatial trends were similar for both interscan times. Researchers provided a detailed description of the OCTA processing steps and parameters to elucidate their influence on quantitative measurements.
Researchers determined that CC impairment, assessed by flow-deficit percentages, was most prominent near CNV boundaries. The lesion-centered zonal analysis technique enabled quantitative CC measurements relative to focal lesions. Researchers wrote that understanding how processing steps, imaging/processing parameters and artifacts can affect quantitative CC measurements is important for longitudinal, OCTA-based studies of disease progression and treatment response.
SOURCE: Moult EM, Alibhai AY, Rebhun C, et al. Spatial distribution of choriocapillaris impairment in eyes with choroidal neovascularization secondary to age-related macular degeneration: A quantitative OCT angiography study.
Retina 2019; Aug 13. [Epub ahead of print].
Real-time PCR & Sequencing for Diagnosing Bacterial Keratitis
Investigators evaluated the efficacy of real-time PCR for 16S ribosomal DNA (16S r-DNA) sequencing to diagnose microbial keratitis in 272 eyes of 272 individuals with keratitis.
Eyes with keratitis were classified as “definite” (n=118) or “likely” (n=71) to have bacterial keratitis, or “non-bacterial” (n=83). Investigators assessed the diagnostic efficacy of real-time PCR and conventional testing by ROC analysis. They retrospectively analyzed the copy numbers of bacterial DNA and clinical characteristics to assess associations with concordant culture results in the “definite” cases. Here were some of the findings:
• The classification/level of bacterial DNA was significantly associated with the diagnostic probability of the three diagnostic categories.
• The classification/level of bacterial DNA had comparable diagnostic efficacy with the AUC at 0.67, with culture at 0.65 and with smear testing at 0.73 (a value of 1.00 would be perfect diagnostic efficacy).
• The efficacy was significantly improved by combining the DNA level with the conventional culture testing with an AUC of 0.81.
• Analysis of the “definite” cases showed culture positivity in 51.8 percent (58 eyes); of these, 41 eyes (70.7 percent) were higher than the cutoff PCR values, and 40 eyes were identified by 16S r-DNA sequencing.
• In culture-negative eyes, the level of bacterial DNA was significantly lower (p=0.0008).
• Eyes with higher bacterial DNA levels had significantly concordant outcomes with sequencing and culture results (p=0.006).
• Having previous antibiotic treatments decreased the bacterial DNA amount by 0.09-fold and was a significant factor for discordance (p=0.006).
Investigators concluded that quantification of the bacterial DNA level and conventional testing improved the diagnostic efficacy of infectious bacterial keratitis.
SOURCE: Shimizu D, Miyazaki D, Ehara F, et al. Effectiveness of 16S ribosomal DNA real-time PCR and sequencing for diagnosing bacterial keratitis. Graefes Arch Clin Exp Ophthalmol. 2019; Aug 13. [Epub ahead of print].
Ranibizumab in Asian Patients with BRVO: BLOSSOM Study
Scientists evaluated the efficacy and safety profile of intravitreal ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion, as part of a 12-month, Phase III, double-masked study.
A total of 283 individuals with BRVO participated. Individuals ages ≥18 years were randomized (2:1) to receive either ranibizumab 0.5 mg or sham. The ranibizumab group received a minimum of three monthly intravitreal injections until stable maximal visual acuity was achieved. This was followed by an individualized, VA stabilization, criteria-driven, pro re nata
regimen. Patients in the sham group received sham injections up to month five and could receive ranibizumab 0.5 mg PRN from month six.
Main outcome measures included the mean average change in best-corrected VA from baseline to month one through month six, and safety up to month 12. Here were some of the findings:
• At baseline, patients’ mean BCVA was 57.4 ±11.7 letters and mean central subfield thickness (CSFT) was 525 ±193.4 μm.
• Compared with sham, ranibizumab treatment resulted in superior VA gains.
• The least squares (LS) mean average change in BCVA from baseline to month one to month six was +12.5 letters in the ranibizumab group and +5 letters in the sham group (LS mean difference between ranibizumab vs. sham: +7.5 letters [CI, 5.5 to 9.5], one-sided p<
• The LS mean change from baseline at month 12 in the ranibizumab vs. sham group in BCVA was +16.4 (14.9, 17.8) vs. +11.4 (9.3, 13.5) letters; and in CSFT was -280 (-291.6, -268.4) vs. -269.7 (-286.2, -253.1) μm.
• The mean number of injections over 12 months was 7 (±2.55 in the ranibizumab group and 3.6 ±1.60 in the sham with ranibizumab group.
• No new safety findings were reported.
Scientists found that individualized PRN ranibizumab treatment was statistically superior to sham at month six and led to early visual gains that were maintained up to 12 months. They added that results from the sham group indicated the importance of early treatment in achieving optimal visual outcomes in BRVO. Furthermore, the scientists wrote, the safety of ranibizumab in the study was consistent with the drug’s well-established safety profile.
SOURCE: Wenbin W, Weisberger A, Zhu L, et al. Efficacy and safety of ranibizumab in Asian patients with branch retinal vein occlusion: Results from the Randomized BLOSSOM study. Opthalmology Retina 2019; Aug. 13. [Epub ahead of print].
Corneal Biomechanics & VF Progression in Eyes with Seemingly Well-controlled IOP
Researchers looked at the incidence and risk factors for glaucomatous visual field progression in eyes with well-controlled intraocular pressure, as part of a prospective cohort.
A total of 460 eyes of 334 glaucoma patients under treatment were included.
Study subjects had mean follow-up of 4.3 ±0.8 years. They were classified as well-controlled if all IOP measurements were under 18 mmHg. Rates of VF progression were calculated using ordinary least squares linear regression of standard automated perimetry mean deviation values over time. Progression was defined as a significantly negative slope of the mean deviation (α=0.05).
Main outcome measures included: rates of change in SAP mean deviation, mean and peak IOP, IOP fluctuation, corneal biomechanics, corneal hysteresis, central corneal thickness and corneal index. Here were some of the findings:
• Of the 179 eyes with well-controlled IOP, 42 (23.5 percent) demonstrated VF progression.
• Researchers found no statistically significant difference between progressing and stable individuals in baseline MD (-6.4 ±7.1 vs. -6 ±6.2 dB; p=
0.346), mean IOP (11.7 ±2 vs. 12.1 ±2.3 mmHg; p=
0.405), IOP fluctuation (1.6 ±0.6 vs. 1.6 ±0.5 mmHg; p=
0.402) or peak IOP (14.3 ±1.9 vs. 14.6 ±2.1 mmHg; p=
• Progressing eyes, compared with stable eyes, had significantly lower CH (8.6 ±1.3 vs. 9.4 ±1.6 mmHg; p=
0.014) and thinner CCT (515.1 ±33.1 vs. 531.1 ±42.4 μm; p=
• In the multivariate analysis, a 1 SD lower corneal index, a summation of normalized versions of CH and CCT, resulted in a 68 percent higher risk of progression (OR: 1.68; CI, 1.08 to 2.62; p=
Researchers deduced that approximately one-quarter of eyes with well-controlled IOP might show VF progression over time. They added that thin corneas and low CH were the main risk factors.
Source: Susanna BN, Ogata NG, Jammal AA, et al. Corneal biomechanics and visual field progression in eyes with seemingly well-controlled intraocular pressure. Opthalmology 2019; Aug 9. [Epub ahead of print].
New World Medical Launches New Glaucoma Drainage Device
New World Medical introduced the Ahmed ClearPath glaucoma drainage device. Developed in partnership with glaucoma surgeons, the Ahmed ClearPath is available in two sizes: 350 mm2 and 250 mm2. The device features a flexible plate with a contour that closely conforms to the curvature of the eye. In addition, the company says that the suture fixation points are positioned more anteriorly on the device than some valveless drainage devices for convenience. The model 350 plate surface is positioned more posteriorly to avoid muscle attachment points, while the model 250 is designed to be a true single quadrant implant that fits between the muscles. The device comes with an optional pre-threaded ripcord and a 23-ga. needle. Read more.
FDA Approves Eylea (Aflibercept) Injection Prefilled Syringe
Regeneron announced the FDA approved the Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea (aflibercept) Injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer Eylea that requires fewer preparation steps compared with vials. The company expects the prefilled syringe to be available to physicians this year. Read more.
Alcon to Launch Precision1 Daily Disposable Contact Lenses
Alcon plans to launch in the United States the newest addition to its contact lens portfolio—Precision1 daily-disposable, silicone hydrogel (SiHy) contact lenses. The lens features proprietary Smartsurface technology—a permanent, micro-thin, layer of moisture at the lens surface designed to help support a stable tear film. The lens, which aims to address common reasons why many new wearers discontinue contact lens wear within the first year, such as poor vision, comfort problems and handling issues, uses a new lens material—verofilcon A with Class 1 ultraviolet-blocking capabilities. Read more.
Aerie Initiates First-in-human Trial of AR-13503 Sustained Release Intravitreal Implant
Aerie initiated patient dosing in a first-in-human clinical trial of the AR-13503 Sustained Release Implant in individuals with neovascular age-related macular degeneration or diabetic macular edema. The multi-arm, 24-week study is being conducted in two sequential stages. The first is a multicenter, open-label, dose escalation study of the safety and tolerability of a single intravitreal injection, using two doses in up to 12 patients. The second phase is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose implants, dosed as monotherapy and in combination with aflibercept (Eylea, Regeneron), compared with aflibercept alone. Read more.
Prevent Blindness Creates Educational Resource for Diabetes
To educate patients on diabetic eye diseases, Prevent Blindness created the “Diabetes and the Eyes” toolkit, available in English and Spanish. The materials include:
• Educator course – for health-care professionals, community health and diabetes educators, and anyone in a caregiving or diabetes education role.
• Fact sheets – with general information about symptoms and risks; and diagnosis, treatment and prevention strategies to educate patients and the public.
• Infographics – shareable graphics designed to educate patients and the public. Users are encouraged to post messages with #VisionandDiabetes.
• Assistance resources – to help patients seek the eye care they require by understanding barriers to access, ways to navigate health-care systems and the intricacies of health insurance.
The English version has received Favorably Reviewed Approval from the American Association of Diabetes Educators. The materials were made possible by funding from the Allergan Foundation. Read more.
Foundation Fighting Blindness Invests $6.5 Million in New Grants
The Foundation Fighting Blindness has committed $6.5 million for 14 new research projects for inherited retinal diseases. The newly funded research efforts include development of a CRISPR/Cas9 therapy for retinitis pigmentosa, a retinal imaging technique using artificial intelligence and several therapies that the Foundation says have strong potential to treat a wide range of inherited retinal diseases. Read more.
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