EyeArt software, a suite of advanced image analysis tools for automated high-throughput screening of diabetic retinopathy (DR), has received the CE mark, said developer Eyenuk (Woodland Hills, Calif.).
According to the company, EyeArt provides "a highly scalable and cost-effective cloud-based DR screening solution that analyzes thousands of patients' eyes in just a few hours. Using color retinal images taken with standard fundus cameras, the software analyzes the high-resolution images of the retina, and uses this information to automate detection of DR." Clinical validation studies found EyeArt had better sensitivity than human graders.
The software is not yet approved in the U.S.
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SkQ1 shows promise in dry eye syndrome
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"Significant positive results" have been shown from a U.S. phase 2 clinical trial of SkQ1 in patients with moderate to severe dry eye syndrome, developer Mitotech (Luxembourg) said in a news release.
SkQ1 is the first mitochondria-targeted antioxidant to reach clinical phase of development for an ophthalmic indication, the company said. The phase 2 study achieved statistically significant treatment effects in both signs and symptoms of dry eye syndrome in the intent-to-treat population (n=90). SkQ1 demonstrated superiority over placebo in several endpoints such as central (P=0.036) and total corneal (P=0.045) fluorescein staining pre- to post-Controlled Adverse Environment (CAE) and grittiness (P=0.058) pre- to post-CAE at week 4 in the intent-to-treat population.
An ophthalmic formulation of SkQ1 is already marketed in Russia as Visomitin. A phase 3 study in the U.S. is expected to begin during the fourth quarter.
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Oral treatment for wet AMD enters phase 2 study
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X-82, an orally administered, dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet age-related macular degeneration (AMD) and solid tumors, has entered phase 2 studies, developer Tyrogenex (Palm Beach Gardens, Fla.) said in a press release. Patients enrolled in the study had previously been treated with Eylea (aflibercept, Regeneron, Tarrytown, N.Y.).
Preliminary data show that X-82 does not exhibit dose-limiting toxicity. This phase 2 study, dubbed APEX, is a randomized, double-masked, placebo-controlled, dose-finding phase 2 study being conducted throughout the U.S. at 20 sites and 5 sites in the U.K. The study is designed to evaluate the safety and efficacy of X-82 in the prevention of vision loss due to wet AMD. APEX is expected to enroll 132 subjects. The primary endpoint of the APEX study is the mean change in visual acuity score from day 1 to 52 weeks after randomization. Another key endpoint is the reduction of the number of injections needed for the duration of the study.
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Allergens and dry eye spikes linked
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Researchers from the University of Miami have determined dry eye strikes most often in spring, just as airborne allergens are surging, the American Academy of Ophthalmology (AAO, San Francisco, Calif.) said in a news release. The study marks the first time that researchers have discovered a direct correlation between seasonal allergens and dry eye, with both pollen and dry eye cases reaching a yearly peak in the month of April.
Allergies and dry eye have traditionally been thought of as 2 separate entities, but with this study the researchers suggest that dry eye sufferers may benefit from allergy prevention in addition to dry eye treatments like artificial tears.
They discovered the correlation between allergies and dry eye by reviewing 3.4 million visits to Veterans Affairs eye clinics nationwide over a 5-year period between 2006 and 2011. During that time, doctors diagnosed nearly 607,000 patients with dry eye. Researchers also charted the monthly prevalence of dry eye compared to an allergy index over time and found seasonal correlations.
A seasonal spike occurred each spring, when 18.5% of patients were diagnosed with dry eye. Another spike came in winter, and the prevalence of dry eye was lowest in summer at 15.3%.
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RESEARCH BRIEFS
- Corneal asphericity influences the refractive outcomes of IOL implantation and should be taken into consideration when using third-generation IOL power formulas, according to Giacomo Savini, MD, and colleagues. Their retrospective comparative case series calculated lens power using the Haigis, Hoffer Q, Holladay 1, and SRK/T formulas to determine the relationship between the error in refraction prediction (i.e., difference between expected refraction and refraction measured 1 month after surgery), and the Q-value was assessed by linear regression. The same IOL model (AcrySof SA60AT, Alcon, Fort Worth, Texas) was implanted in 115 eyes of 115 consecutive patients. Regression analysis showed a statistically significant relationship between the error in refraction prediction and the Q-value with all formulas and all devices. In all cases, a more negative Q-value (prolate cornea) was associated with a myopic outcome, whereas a more positive Q-value (oblate cornea) was associated with a hyperopic outcome. The highest coefficient of determination was detected between the Hoffer Q formula and the Placido-disk corneal topographer (R2=0.2630), for which the error in refraction prediction (y) was related to the Q-value (x) according to the formula y = −0.2641 + 1.4589 × x. The study is published in the Journal of Cataract & Refractive Surgery.
- Posterior capsule-optic inadhesion is a prevalent capsule-IOL interaction following cataract surgery, according to a prospective study. Xiangjia Zhu and colleagues examined 518 consecutive patients who had undergone uneventful phacoemulsification and posterior chamber IOL implantation. The overall rate of posterior capsule-optic inadhesion on the first day after surgery was 215/518 (41.5%), and it decreased to 37/518 (7.1%) at 2 months post-surgery. Posterior capsule-optic inadhesion can be morphologically classified into 5 types with 3 outcomes, of which gradual absorption of the accumulated fluid predominated for all IOLs. The clinical characteristics of patients with inadhesion varied with IOL type. Notably, visual quality data (Strehl ratios and modulation transfer function) were poorer in patients with posterior capsule-optic inadhesion, especially in those with irregular forms of suspension. Four cases of capsular contraction syndrome were identified among the patients with inadhesion. The study is published online ahead of print in Acta Ophthalmologica.
- The incidence of presumed endophthalmitis after intravitreal injections of antivascular endothelial growth factors (VEGF) or corticosteroids was low and the prognosis poor, according to D. Dossarps and colleagues. From January 2, 2008 to June 30, 2013, a total of 316,576 intravitreal injections from 25 French ophthalmic centers were included in this retrospective case series. During the study period, 65 cases of presumed endophthalmitis were found, giving an overall incidence of 0.021% (2.1 in 10,000 injections). The median number of days from injection to presentation was 4 (1-26) days. The most common symptom was vision loss. Bacterial identification was achieved in 43.4%. The most frequent pathogens were Gram-positive bacteria (91.3%), including coagulase-negative Staphylococcus in 78.3%. Neither the interval between injection and presentation for endophthalmitis nor the clinical signs differentiated culture-positive from culture-negative cases. In multivariate analysis, the use of a disposable conjunctival mould assist device and the use of prophylaxis with an antibiotic or antiseptic were significantly associated with an increased incidence of endophthalmitis (P=0.001). The majority of patients had worse visual acuity after 3 months of follow-up when compared with acuity before endophthalmitis. The study is published online ahead of print in the American Journal of Ophthalmology.
NEW PRODUCT BRIEFS
- Mile High Ophthalmics (Denver, Colo.) launched its VERUS ophthalmic caliper, designed by Malik Kahook, MD, and colleagues to help surgeons create a round, centered capsulorhexis, the company announced. VERUS is designed to provide surgeons with a way to create a round and repeatable capsulorhexis, while minimizing the impact to procedure time and cost.
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Important Safety Information about PROLENSA®
- PROLENSA® contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
- All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
- There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs.
- There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. * Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
- PROLENSA® should not be instilled while wearing contact lenses. The preservative in PROLENSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA®.
- The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.
Click here for Prescribing Information about PROLENSA®.
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EyeWorld Weekly Update is edited by Stacy Majewicz and Michelle Dalton.
EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Eric D. Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Eric D. Donnenfeld, MD, refractive editor; and John A. Vukich, MD, international editor
For sponsorship opportunities or membership information, contact: ASCRS*ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRSOpinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA.
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