EW Weekly, March 11, 2016

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March 11, 2016
Volume 21 , Number 10

FDA approves PanoCamwidefield imaging system

The U.S. Food and Drug Administration has approved the PanoCam Pro Wide-Field Imaging System for ocular imaging of all newborn infants, developer Visunex Medical Systems (Fremont, California) said in a news release. PanoCam Pro is a wireless imaging system that "may help detect external, anterior, and posterior segment vision disorders," the company said, including retinopathy of prematurity and retinoblastoma.

FDA approves Triggerfish contact lens

The U.S. Food and Drug Administration has approved a 1-time use contact lens that may help practitioners identify the best time of day to measure a patient's IOP, the agency said on its website. The Triggerfish (Sensimed, Lausanne, Switzerland) has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye's volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. "The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained," said William Maisel, MD, acting director, Office of Device Evaluation, Center for Devices and Radiological Health, FDA. The Triggerfish is indicated for use in adults age 22 and older under the direction and supervision of a healthcare professional.

SVOne granted CE mark

The SVOne, a handheld Shack-Hartmann wavefront aberrometer, has received CE mark approval, developer Smart Vision Labs (New York) said in a press release. In clinical studies, SVOne has been shown to be as accurate as much larger desktop autorefractor units, the company said.

Raindrop Near Vision Inlay shows promising 1-year results

An ongoing phase 3 U.S. clinical study evaluating the Raindrop Near Vision Inlay for the treatment of presbyopia found the inlay "significantly improved near visual performance and produced a 92% rate of satisfaction among study subjects 1 year following the procedure," developer ReVision Optics (Lake Forest, California) said in a press release. Results of the study are published in Ophthalmology; findings include average uncorrected near visual acuity improved by 5 lines on a standard eye chart in the treated eye. There was no loss in binocular distance vision; 93% of subjects achieved uncorrected near visual acuity of 20/25 or better in the treated eye; and mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances with no loss in contrast sensitivity.

OTX-101 for DED starts confirmatory phase 3 study

The first patient has been enrolled in a phase 3 confirmatory study of Seciera (OTX-101), a novel, patented nanomicellar formulation of cyclosporine for the treatment of dry eye disease (DED), said developer Auven Therapeutics (St. Thomas, U.S. Virgin Islands). Auven plans to enroll about 700 patients in this study at 51 U.S. sites. The phase 3 study will aim to confirm the significant, clinically meaningful increase in tear production demonstrated in the previous phase 2b/3 study, Auven added. Top-line results are expected during the fourth quarter of 2016.

First patients in Flexivue Microlens FDA study complete 12-month visits

All subjects treated as part of the first stage of a Food and Drug Administration pivotal study on the Flexivue Microlens for the treatment of presbyopia have completed their 12-month postoperative visits, Presbia (Dublin) said in a press release. The FDA permitted Presbia to conduct its pivotal study in 2 stages, the company said. The first stage had an enrollment of 75 subjects and the second stage an additional 346 subjects. The second stage enrollment was completed in early September 2015, and those participants will begin their 12-month postoperative visits this month. The Flexivue Microlens has received regulatory approval and is commercially available in more than 40 countries across Europe, Asia Pacific, Latin America, the Middle East, and Africa.

RESEARCH BRIEFS

  • Corneal higher order aberrations (HOAs) and the higher-order Strehl ratios deteriorated after moderate and high myopic ablations, according to Luis F. Brenner, MD. In his prospective, interventional study, eyes that had aberration-free myopic ablation were divided into 3 groups, based on the spherical equivalent (SE). The corneal HOAs and higher-order Strehl ratios of 88 eyes were calculated before surgery and 3 months after surgery. The postoperative uncorrected distance visual acuity, corrected distance visual acuity, and SE did not present statistical differences among groups. For a 6-mm pupil, the corneal HOA showed a mean increase of 0.17 μm (P<.001) and the corneal higher-order Strehl ratio presented a reduction of 0.03 (P=.001). The study is published in the Journal of Cataract & Refractive Surgery.
  • The use of full iris prostheses without embedded fiber mesh, even in cases with remnant iris, and the use of slightly smaller implants than officially recommended may be beneficial for patients with aniridia, according to a study. A. Rickmann and colleagues retrospectively evaluated 34 patients who had received a custom-made, flexible artificial iris developed by HumanOptics and Koch between 2004 and 2013. Only eyes with a minimum follow-up period of 2 years were included. With a mean follow-up of 50 months, no repositioning of prostheses was necessary. In cases of keratopathy (17.6%) visual function increased from baseline mean 1.6 logMAR (±0.7) to 1.2 logMAR (±0.7) after artificial iris implantation. The remaining iris tissue darkened during the follow-up in 23.5% (83.3% with and 10.7% without mesh), 8.8% developed glaucoma (50% with and 0% without mesh), and 14.7% needed consecutive surgery after prostheses implantation (50% with and 7.1% without mesh). In 3 out of 7 trauma cases (42.9%) silicone oil was spilled into the anterior chamber after 2.5 years on average. The study is published in Graefe's Archives of Clinical and Experimental Ophthalmology.
  • The potential benefits of topical corticosteroid therapy, for treating pain and discomfort, are not associated with worse outcomes when initiated after starting modern antiamoebic therapy (AAT) to treat Acanthamoeba keratitis (AK), according to Nicole Carnt, PhD, and colleagues. They evaluated patients diagnosed with AK at Moorfields Eye Hospital, London, between January 1991 and April 2012. In a multivariable analysis, in 129 eyes (1 eye per patient) without scleritis and hypopyon at the start of AAT, topical corticosteroids were not associated with worse outcomes, even when corticosteroids had been used before the start of AAT. Risk factors significantly associated with worse outcomes were topical corticosteroid use before the start of AAT, a corneal ring infiltrate (together with at least 1 other feature of AK) present at the start of AAT, and age ≥33 years at the start of AAT. The study is published online ahead of print in Ophthalmology.

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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