Health Canada has granted a medical device license to Bioptigen’s Envisu SDOIS C2200 and C2300 ophthalmic imaging systems, the Research Triangle Park, N.C.-based manufacturer said. The Envisu C series SDOIS imaging systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures, according to Bioptigen. The company has said the handheld scanner makes the series “particularly useful for pediatric and non-ambulatory patients.” The devices are already approved in the E.U. and are awaiting regulatory approval in the U.S.

Kowa Optimed (Torrance, Calif.) received 510(k) approval from the FDA for its VX-20 retinal camera, the company said in a news release. The VX-20 offers non-mydriatic, mydriatic, and fluorescein angiography modes with 50-degree and 30-degree views. Additionally, the VX-20 has an autofluorescence mode to provide further diagnostic investigation of the health of the retina, the company said.

The VibeX (riboflavin ophthalmic solution)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery has been submitted to U.S. regulators, developer Avedro (Waltham, Mass.) said in a news release. In 2011, the VibeX/KXL System was granted orphan designation by the FDA. The VibeX/KXL System for corneal collagen crosslinking received the CE mark in 2010 and has been commercially available internationally since that approval.

RESEARCH BRIEFS

• A pre-op stromal edema that lasted more than 12 months has an adverse effect on visual outcomes in patients undergoing Descemet’s stripping automated endothelial keratoplasty (DSAEK), according to Naoyuki Morishige, M.D., and colleagues. The group evaluated two groups of DSAEK patients: Group A had pre-op stromal edema for less than 12 months, Group B had pre-op stromal edema for longer than 12 months. Post-op corrected distance visual acuity (CDVA) in Group A ranged from 20/50 to 20/16 at 3 months and from 20/66 to 20/16 at 6 months; the maximum CDVA was 20/40 to 20/13. The post-op CDVA in Group B ranged from 20/66 to 20/40 at 3 months and 6 months; the maximum CDVA was 20/66 to 20/33. The authors recommend DSAEK be performed shortly after the onset of edema. The study is published in the Journal of Cataract & Refractive Surgery.
• Glaucoma is becoming more and more recognized as a manifestation of both ocular and systemic risk factors, Omar Faridi, M.D., and colleagues reported. Sleep disorders, primarily obstructive sleep apnea (OSA), have been associated with glaucoma as an independent risk factor from IOP, the researchers said. OSA may cause hypoxia-mediated damage to blood vessels, which could alter blood flow to the optic nerve head and would lead to decreased ocular perfusion pressure. The review article is published in Clinical & Experimental Ophthalmology.

NEW PRODUCT BRIEFS

• Vistakon (Jacksonville, Fla.) launched its 1-Day Acuvue Moist contact lenses for astigmatism in the U.S., the company said. The lenses feature a proprietary component to keep the lens in place and “quickly realign if it rotates out of position,” the company said. The lenses block 82% of ultraviolet-A radiation and 97% of ultraviolet-B radiation.
• Gulden Ophthalmics (Elkins Park, Pa.) introduced the Diabetes Eye-Plus Model that demonstrates the effect of unsuccessfully treated diabetes on four body systems. The new model “helps eye care professionals demonstrate the devastating effects of untreated/unmonitored diabetes on patients’ kidneys, nerves, arteries, and of course, retinas,” the company said. The hope is when patients see how diabetes can affect other body systems, they will be more compliant with treatment regimens.
• ThromboGenics (Iselin, N.J.) introduced a website devoted solely to symptomatic vitreomacular adhesion (VMA), , to educate patients about the disease. VMA may lead to symptoms such as decreased visual acuity and central visual field defect, the company said.

CORRECTION

The following was published in EyeWorld Week last week as part of the EyeWorld Meeting Reporter from the American Glaucoma Society's annual meeting:
Ziemer (Port, Switzerland) introduced the FEMTO LDV Z Models Z2, Z4, and Z6. Operating at pulse frequencies in the megahertz range and with very low pulse energy, the threshold for tissue disruption is reached at very short interaction time. The advantages are excellent visual outcomes and fast recovery. The latest models are designed to be moved between various operating theatres. 

The announcement should also have included the following important information: