EW Weekly, March 7, 2014

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March 7, 2014
Volume 19 , Number 6

Visian ICL with CentraFLOW approved in Japan

The Visian Implantable Collamer Lens with CentraFLOW technology has been approved by the Japanese Ministry of Health, Labor and Welfare, said developer STAAR Surgical (Monrovia, Calif.). The Japanese approval expands the range of treatment for myopia down to –3 D, the company added.
The CentraFLOW technology eliminates the need for a peripheral iridotomy, which lets surgeons diagnose and perform surgery on the same day, according to one of the Japanese investigators. The approved treatment range for the Visian ICL with CentraFLOW is –3.0 diopters to –18 diopters of myopia and the same spherical range for the Visian Toric ICL with CentraFLOW and from +1.0 D to +4.5 D of astigmatism.

RPS receives CLIA waiver for InflammaDry

The U.S. Food and Drug Administration has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the InflammaDry, a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease (DED), developer Rapid Pathogen Screening (RPS, Sarasota, Fla.) said in a news release.
The InflammaDry test detects elevated levels of matrix metalloproteinase 9 (MMP-9) in the tears of patients with DED. The single-use test does not require additional equipment to administer or interpret results, RPS said. The InflammaDry test is CE-marked, 510(k) cleared, and commercially available in Europe and Canada, among other countries.

Eylea filed in Japan for DME

Eylea (aflibercept) has been filed with Japanese regulatory authorities for the treatment of diabetic macular edema (DME), developer Regeneron (Tarrytown, N.Y.) said. Outside the U.S., Bayer Healthcare (Berlin, Germany) has exclusive marketing rights.
The submission of Eylea for DME in Japan is based on data from the VISTA-DME, VIVID-DME and VIVID-Japan studies. In the phase 3 VIVID-DME and VISTA-DME trials, Eylea 2 mg dosed monthly and Eylea 2 mg dosed every two months (after five initial monthly injections) achieved the primary endpoint of significantly greater improvement in best corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks.

Drug-eluting intracanalicular plugs get reimbursement code

Category III Current Procedural Terminology (CPT) code 0356T is now designated for the insertion of a drug-eluting implant, including punctal dilation and implant removal when performed, into the lacrimal canaliculus, Ocular Therapeutix (Bedford, Mass.) announced. The code becomes effective July 1, 2014.
Ocular Therapeutix is currently in clinical trials for dexamethasone intracanalicular plugs (OTX-DP) for the treatment of postoperative inflammation and pain and travoprost intracanalicular plugs (OTX-TP) for reduction of intraocular pressure in patients with glaucoma or ocular hypertension.

ThromboGenics starts phase 4 study on Jetrea

The phase 4 U.S. Ocriplasmin Research to Better Inform Treatment (ORBIT) study is designed to generate further data on the real-world use of Jetrea (ocriplasmin, ThromboGenics, Leuven, Belgium), the company said.
The ORBIT study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) across 120 retina centers in the U.S. The prospective, observational study will assess clinical outcomes and safety of Jetrea administered for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes, ThromboGenics said. ORBIT is expected to start recruiting patients this month and is due to complete in mid-2016; patients will be followed for up to 12 months.

Corcoran Consulting Group granted CPMA credentials

Members of Corcoran Consulting Group (San Bernardino, Calif.) have been granted the Certified Professional Medical Auditor (CPMA) credentials, the company said, adding only about 2,000 people nationwide have the credential from the American Academy of Professional Coders.

In memoriam

Melvin L. Rubin, MD, former president of both the American Academy of Ophthalmology (San Francisco) and the Association for Research in Vision and Ophthalmology (Rockville, Md.), passed away last month at the age of 83.
Dr. Rubin served two years as the executive secretary of the Vision Research Training Committee at the National Institutes of Health (Bethesda, Md.), and was a member of the ophthalmology faculty at the University of Florida College of Medicine from 1963 to 1995, when, after 17 years as chairman, he stepped down, continuing to hold the Richardson Eminent Scholar Chair. He became professor emeritus in 1997.

RESEARCH BRIEFS

  • Using either the 350-μm or 400-μm microkeratome blade for Descemet’s stripping automated endothelial keratoplasty (DSAEK) does not alter the outcomes in terms of visual acuity, endothelial cell density, or surgical complications, according to Robert P.L. Wisse, MD, and colleagues. The retrospective analysis of all DSAEK procedures performed at one institute from January 2011 to December 2012 (N=102) included a VA assessment at every postop visit, and an ECD assessment at six and 12 months. A total of 60 grafts were prepared with the 350-μm blade and 39 with the 400-μm blade. Baseline characteristics did not differ materially. Grafts dissected using the 350-μm knife were significantly thicker than the grafts dissected with the 400-μm blade, with values of 25747 μm and 22233 μm, respectively (P=0.01). The study is published in Cornea.
  • Torsional phacoemulsification performed with a 45-degree aperture angled tip provided more effective lens removal with a lower cumulative dissipated energy (CDE) and less central corneal thickness (CCT) change than a 30-degree aperture angled tip, according to a study. F. Helvacioglu and colleagues assigned eyes to 2.2 mm microcoaxial phacoemulsification using the torsional mode with a 45-degree (Group 1) or 30-degree (Group 2) aperture angled tip. A quick-chop surgical technique was used. The mean CDE and torsional amplitudes were significantly lower in Group 1 (P=.002 and P=.001, respectively). The mean balanced salt solution volume was 73.3019.87 cc in Group 1 and 74.3019.44 cc in Group 2 (P=.821). The mean CCT change was 52.4038.08 μm and 99.3547.14 μm in Group 1 and Group 2, respectively (P<.001). The study is published in the Journal of Cataract & Refractive Surgery.
  • The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin-C (MMC) than tube shunt surgery in the Tube Versus Trabeculectomy (TVT) Study, according to the study group authors. The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. Randomization assigned 107 patients to surgery with a tube shunt (350-mm2 Baerveldt glaucoma implant) and 105 patients to trabeculectomy with MMC (0.4 mg/ml for 4 minutes). Additional glaucoma surgery was performed in eight patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study, and the five-year cumulative reoperation rate was 9% in the tube group and 29% in the trabeculectomy group (p=.025). The cumulative probability of failure at one, two, three, and four years after additional glaucoma surgery was 0%, 43%, 43%, and 43%, respectively, in the tube group, and 0%, 9%, 20%, and 47% in the trabeculectomy group (p=.28). Reoperations to manage complications were required in one (13%) patient in the tube group and five (28%) patients in the trabeculectomy group (p=.63). The study is published in American Journal of Ophthalmology ahead of print.

NEW PRODUCT BRIEFS

  • Rhein Medical (St. Petersburg, Fla.) introduced a Tip Protector Clip for its new line of Resposable 3-D knives. The clip is removable and is designed to slip onto the resposable handle to protect the blade during sterilization. The clip is easily removed after sterilization for repeated knife uses. The clip is reusable, autoclavable, made of stainless steel, guaranteed for life, and available for a 30-day surgical evaluation.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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 Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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