Rapid Pathogen Screening has received a Clinical Laboratory Improvement Amendments waiver from the Food and Drug Administration for InflammaDry—a rapid, disposable, in-office test to aid in the diagnosis of dry-eye disease.

Obtaining the CLIA waiver, in addition to its FDA 510(k) clearance, enables the InflammaDry test to be used throughout the United States, an expansion from its current use internationally. CLIA-waived status is granted to tests that are simple to perform and have an insignificant risk of producing an erroneous result. The InflammaDry test can be administered by any medical office personnel in health-care facilities with a CLIA Certificate of Waiver.

The InflammaDry test detects elevated levels of matrix metalloproteinase 9, a clinically relevant inflammatory marker, in the tears of patients with dry-eye disease. InflammaDry is a single-use test that requires no additional equipment to administer or interpret results. Using only a small sample of human tears, the four-step process takes less than two minutes to complete and can be performed by a technician during a patient’s initial workup. Results are available in 10 minutes, allowing a treatment plan to be established with the patient during his initial office visit. Providers are advised to bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method, for the InflammaDry test. Medicare payment for this code is currently $15.74. RPS anticipated that InflammaDry inventory would be available for sale in the United States in March 2014. For information, visit inflammadry.com or call (941) 556-1850.


Accutome Expands AccuSharp Series of Surgical Knives
Accutome has added
to its AccuSharp Series of ophthalmic surgical knives with the new M-Series Angled Disposable Slit Knives.

The M-Series is made of the highest quality stainless steel and features a new “teardrop” bevel design for superior sharpness. The new knives provide surgeons with a 2.0-mm depth indicator to help generate proper wound architecture. For sharps safety, each blade locks into a protective plastic case. The M-Series comes in a variety of sizes compatible with the latest micro-incision cataract procedures.

Free samples are available by request. To learn more or request a sample, visit accutome.com; e-mail info@accutome.com; or call 1 (800) 979-2020.


Gulden Offers Orbital Sizers & Spheres
Gulden Ophthalmics has
introduced enucleation and evisceration Eye Orbit Sizer Kits that help surgeons and/or the surgical support staff rapidly and easily determine the proper size for orbital implants or other ocular prostheses.

The Orbital Sizer Kits from Gulden save time and provide more accurate measurements and fitting of orbital implants. Each package contains five autoclavable re-useable sizers in 14, 16, 18, 20 and 22 mm sizes.
The sizers are constructed of stainless steel, providing excellent dimensional stability. The sizes are etched into the 3-inch long handles.

Gulden also offers its Venus line of sterile, surgery-ready eye spheres (same sizes as above) as well as a line of eye conformers. Eye spheres are permanent implants that occupy the cavity that results from the surgery; eye conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process.

For information, call (215) 884-8105; fax (215) 884-0418; e-mail: info@guldenophthalmics.com; or visit guldenophthalmics.com.


Ocusoft Adds Night Ointment

Ocusoft has introduced
Retaine PM Nighttime Ointment for relief of severe dry eye.

Designed to keep eyes lubricated and comfortable during sleep, Retaine PM is a preservative-free, oil-based formula and is packaged in a large, economical 5-gram tube, 43 percent larger than traditional 3.5-gram tubes.
 
Retaine PM joins the line of Retaine brand eye-care products, including artificial tears and nutritional supplements, available through eye-care professionals. Introductory discount pricing is available to practitioners dispensing from their office; however, patients may also order online directly at ocusoft.com/retaine. For information, call 1 (800) 233-5469 or visit ocusoft.com.


Zeiss Introduces Progressive Choice Plus Sport Lenses
Zeiss has extended
its line of Zeiss Progressive Choice lenses with the addition of Progressive Choice Plus Sport, a lens specifically designed for wrap frames.

The Choice Plus Sport design combines advanced customization for the patient’s full prescription with proprietary Zeiss prism compensation. This combination widens the area of clear vision by as much as 50 percent over standard lens designs in wrap frames, while dramatically reducing unwanted prism, the company says. It is available in two corridor lengths, with minimum fitting heights of 13 and 17 mm. Progressive Choice Plus Sport lenses are fully compatible with i.Scription by Zeiss, which addresses the effects of the patient’s higher-order wavefront aberrations.

Progressive Choice Plus Sport lenses are available in 1.50 Hard Resin, 1.53 Trivex and 1.59 polycarbonate, with polarized options in all materials.


From Topcon: Imagenet 5 Digital Imaging System
Topcon Medical Systems
has released the DICOM-compliant Imagenet 5 Digital Imaging System. Imagenet 5 is fully featured software for ophthalmic imaging capable of acquiring, displaying, enhancing, analyzing and saving digital images obtained with a variety of Topcon photographic devices, such as mydriatic and non-mydriatic retinal cameras and photo slit lamps. Imagenet 5 features a robust SQL expanded database and has numerous image-management functions that facilitate image acquisition, enhancement, measurement and comparison.

The digital acquisition procedures of Imagenet 5 cover color fundus imaging, red-free photography, fluorescein angiography, fundus auto fluorescence, indocyanine green angiography and photo slit-lamp imaging.

The Modality Work list utilization gives Imagenet 5 the capability of querying and displaying the work list provided by the EMR/EHR for the operator to select the scheduled patients for each procedure. Image-net 5 easily integrates with Topcon’s Synergy Ophthalmic Data Management System for complete connectivity. Imagenet 5 allows for review and image manipulation and can export images in various standard image formats as well as DICOM format. It has printing capabilities and runs on the Windows 7 operating system. For information, visit topconmedical.com.


Konan Expands Testing System With iPad-Enabled Amsler Grid
Konan’s Chart2020 has
been expanded with a Blind Spot Amsler test. It is now available on the Chart2020 DUO app at the Apple iTunes store. The Amsler test for iPad is a newly released add-in feature of Konan’s Chart2020 DUO, available for a limited time at an introductory price from the iTunes Store. The Amsler test features the Blind Spot Amsler strategy, which provides a basis for easily controlling test distances, important for repeated tests over time.

The Chart2020 Duo app provides a framework for near and intermediate distance tests, as well as the most advanced controller for distance visual acuity and ocular performance testing for the Chart2020 Windows application. Chart2020 is an advanced eye-testing software solution featuring guided and self-scoring Konan Wizards, a unique user experience with one button control using Smart Docks, and the Chart2020 Duo application for the iPad retina display. For information, visit konanmedical.com REVIEW