EW Weekly, March 14, 2014

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March 14, 2014
Volume 19 , Number 7

Nidek & RS-3000 Advance OCT granted 510K clearance

U.S. regulators have granted 510K clearance to the RS-3000 Advance Optical Coherence Tomographer (OCT), said developer Nidek (Fremont, Calif.). The OCT system incorporates a scanning laser ophthalmoscope for evaluating the retina and choroid, the company said.
The RS-3000 features high speed scanning of 53,000 A-scans/sec during acquisition with tracing as well as two additional higher sensitivity scanning modes with tracing that may enable imaging through media opacities. Finally, the OCT system “can seamlessly integrate with most EMR systems using the Navis-EX image filing software, which networks the RS-3000 Advance and other Nidek imaging devices,” the company said.

China approves IOPtiMate for glaucoma surgery

IOPtiMate, a surgical device that enables eye surgeons to perform accurate CO2 laser-assisted sclerectomy surgery (CLASS), has been granted regulatory approval in China, IOPtima (Tel Aviv, Israel) announced. The CLASS procedure reduces elevated intraocular pressure (IOP) in glaucoma patients by thinning the sclera of the eye, thus restoring the natural fluid percolation without penetrating the eye globe. The system transforms complex and highly risky glaucoma surgery into a safe, elegant, and precise laser-assisted procedure, the company said.

First study patients implanted with FluidVision lens

The first 10 patients enrolled in a multicenter study on the FluidVision accommodating IOL have been implanted, according to developer PowerVision (Belmont, Calif.). Patients received their implants at the three eye centers in South Africa; four sites in Germany will begin enrolling patients later in 2014. The planned enrollment in this study is 115 participants undergoing cataract surgery.
The FluidVision lens is a fluid-controlled accommodating IOL that contains fluid inside the lens that moves in response to the natural muscle forces in the eye, PowerVision said in a news release. The FluidVision lens “mimics the eye’s natural accommodative process, becoming thicker when the patient needs to see up close or thinner when he or she needs to see far away,” the company added.
This study will form the basis for PowerVision’s CE marking of the FluidVision lens in the European Union, expected some time next year, the company said.

Trabodenoson, latanoprost in phase 2 study for glaucoma

A phase 2 study on trabodenoson in combination with latanoprost in patients with elevated IOP that remains uncontrolled despite ongoing treatment with latanoprost has begun, according to developer Inotek Pharmaceuticals (Lexington, Mass.). The study is a randomized, double-masked, active-controlled, multicenter trial comparing trabodenoson plus latanoprost, to timolol (the active comparator) plus latanoprost, in 120 patients with ocular hypertension or primary open-angle glaucoma, with a treatment time of three months. Trabodenoson will be dosed either BID or QD, Inotek said. Top line data is expected later this year.
Trabodenoson is believed to reduce IOP by increasing aqueous fluid outflow via the eye’s trabecular meshwork; currently approved medications do not utilize the trabecular meshwork in their mechanisms of action. In earlier studies, trabodenoson has been shown to increase the natural metabolic activity of the trabecular meshwork by upregulating proteases found in the eye. These proteases are responsible for clearing out hydrolyzed proteins, which block flow through the trabecular meshwork, the company explained.

ThromboGenics granted 3 million euros to study DME

ThromboGenics (Leuven, Belgium) has been awarded a 3 million euro grant to support research into potential new biotherapeutics for the treatment of diabetic macular edema (DME), the company said. The aim of these new therapeutics will be to reduce the vascular leakage and inflammation associated with DME. ThromboGenics will generate the new biotherapeutic candidates by leveraging the AMP-Rx protein design technology that the company licensed from Eleven Biotherapeutics in May 2013, the company said.

RESEARCH BRIEFS

  • Meibomian gland function may be altered without accompanying structural changes after cataract surgery, according to a group of researchers. Kyung Eun Han, MD, and colleagues prospectively enrolled 58 eyes of 48 patients who underwent phacoemulsification; patients were evaluated preoperatively and at one month and three months postoperatively. The ocular symptom scores were worse at one month and three months postoperatively (P<0.001 and P<0.001, respectively). Lid margin abnormalities were significantly increased (P<0.001 and P<0.001, respectively) and tear film break-up time decreased postoperatively (P<0.001 and P<0.001, respectively). Meibum expressibility decreased at three months postoperatively (P=0.016); however, meibography score, superficial punctate keratopathy, lower tear meniscus height, depth, and area, and Schirmer test did not change significantly postoperatively. The article is published online ahead of print in the American Journal of Ophthalmology.
  • The predictability and self-reported clarity of vision of wavefront-guided LASIK were better with the small-spot scanning laser than with a variable-spot scanning laser, according to a study. C.Q. Yu and E.E. Manche prospectively compared LASIK outcomes between two wavefront-guided excimer laser systems in the treatment of myopia in 100 eyes of 50 patients. One eye of patients was treated with the Allegretto Wave Eye-Q system (small-spot scanning laser, Alcon, Fort Worth, Texas) and the fellow eye with the VISX Star CustomVue S4 IR system (variable-spot scanning laser, Abbott Medical Optics, Santa Ana, Calif.). The mean preoperative spherical equivalent refraction was –3.89 D1.67 D and –4.18 D1.73 D in the small-spot scanning laser group and variable-spot scanning laser group, respectively. There were no significant differences in preoperative higher order aberrations between the groups. At 12 months postoperatively, all eyes in the small-spot scanning laser group and 92% in the variable-spot scanning laser group were within 0.50 D of the intended correction (P=.04). At that time, the small-spot scanning laser group had significantly less spherical aberration and significantly less mean total higher order root mean square. Subjectively, patients reported that the clarity of night and day vision was significantly better in the eye treated with the small-spot scanning laser. The study is published in the Journal of Cataract & Refractive Surgery.
  • There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic, according to a study from the Infant Aphakia Treatment Study Group. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group, the study authors said. The Infant Aphakia Treatment Study is a randomized clinical trial with five years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years. The median logMAR visual acuity was not significantly different between the treated eyes in the two treatment groups; about 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least one adverse event after cataract surgery. The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs. 28% of eyes in the IOL group (P=.55). The study is published online ahead of print in JAMA Ophthalmology.

NEW PRODUCT BRIEFS

  • Topcon Medical Systems (Oakland, N.J.) launched 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.

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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