EW Weekly, May 20, 2016

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May 20, 2016
Volume 21 , Number 18

EVO Visian ICL granted Canadian approval

The EVO Visian ICL has been granted regulatory approval in Canada, developer STAAR Surgical (Monrovia, California) said in a news release. The EVO is an implantable collamer lens for the treatment of myopia, and will be marketed in power ranges of -3.0 D to -18.0 D, STAAR added. Clinical data show that the EVO ICL provides predictable correction of high degrees of refractive errors, with the vast majority of patients achieving and maintaining 20/20 or better visual acuity through 5 years of follow-up. Review of the peer-reviewed published literature showed an excellent safety profile: 8 studies including data from 1,291 eyes followed for up to 5 years describe a zero incidence of significant complications, STAAR reported.

Oculeve pivotal trials meet primary, secondary endpoints for DED

The Oculeve Intranasal Tear Neurostimulator, the first and only neurostimulation device for increasing tear production in dry eye disease (DED), has met primary and secondary endpoints in 2 pivotal trials, developer Allergan (Dublin) said in a news release. Based on the data, a premarket submission for the device is on track to be submitted to the Food and Drug Administration in the second half of 2016. The OCUN-009 study is a prospective, randomized, controlled, double-masked, multicenter, crossover trial in which participants used an active device and 2 control applications. The primary effectiveness endpoint of increased tear production over basal during intranasal application as measured by Schirmer score compared to both controls was met. The OCUN-010 study design was a prospective, single-arm, multicenter, open-label clinical trial in which participants used the Oculeve Intranasal Tear Neurostimulator to stimulate tear production for 180 days. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at day 180 was met. Secondary endpoints of increased tear production as measured by Schirmer score during application of the device compared with basal Schirmer score at days 0, 7, 30, and 90 were also met. All device-related adverse events were mild in nature. There were no device-related serious adverse events. No patients discontinued treatment due to adverse events.

Schepens researchers develop glasses for hemianopia patients

Researchers from the Schepens Eye Research Institute (Boston) have designed 3 new eyeglasses using high-power prisms to optimally expand the visual fields of patients with hemianopia, the Institute said in a news release. Eli Peli, MSc, OD, and his team have commercialized prism devices that can expand the visual fields of patients with hemianopia by as much as 30 degrees, optically shifting objects from the blind side of the visual field to the seeing side. The new glasses embed the prism in a spectacle lens to allow up to 36 degrees of expansion to the visual field; use a bi-part double Fresnel prism combining 2 prism segments angled to each other to allow for up to 43 degrees of expansion to the visual field on the patient's blind side and an increase to 14 degrees scanning range into the blind side; or use a pair of angled mirrors to deflect the image from the blind side to the seeing side to allow for up to 40 degrees of expansion to the visual field on the patient's blind side with much wider scanning range permitted.

Symfony IOL pivotal study results "positive"

A pivotal clinical trial of the Tecnis Symfony 1-piece acrylic IOL met its primary endpoint of improved intermediate vision, developer Abbott Medical Optics (Abbott Park, Illinois) said in a news release. The clinical trial was a prospective, multicenter, bilateral, randomized, double-masked clinical investigation conducted at 15 U.S. sites. It evaluated the safety and effectiveness of the Tecnis Symfony 1-piece acrylic IOL in 148 patients compared with 150 patients who received a Tecnis 1-piece aspheric acrylic (monofocal) IOL. The study had 2 primary endpoints: uncorrected intermediate visual acuity in 1 eye and distance corrected intermediate visual acuity at 66 cm in 1 eye. Both of these primary endpoints were met, and these data will be used to support the regulatory application of the Tecnis Symfony IOL in the U.S., Abbott Medical Optics said.

RESEARCH BRIEFS

  • Clinical outcomes of 3 different techniques of combined cataract surgery and refractive corneal inlay implantation had no apparent differences among them, according to N.R. Stojanovic and colleagues. In their comparative pilot study, 15 patients with bilateral cataract were allocated to 1 of 3 groups with a different combination of surgical steps (cataract surgery, intrastromal pocket creation, and Flexivue Microlens [Presbia, Dublin] implantation). In the 3-step group, the intracorneal pocket was created in the non-dominant eye, bilateral cataract surgery was performed 3 months later, and the intracorneal inlay was inserted 3 months after that. In the 2-step at 3 days group, bilateral cataract surgery was performed 3 days after pocket creation and inlay implantation in the non-dominant eye. In the 2-step at 3 months group, the pocket creation and the inlay implantation were performed in the non-dominant eye 3 months after bilateral cataract surgery. Twelve months after the inlay implantation, mean monocular uncorrected distance visual acuity was 20/32 in the 3-step group, 20/32 in the 2-step at 3 days group, and 20/25 in the 2-step at 3 months group. Achieved mean monocular uncorrected near visual acuity was similar in the 3 groups (20/25). The visual and refractive outcomes did not show significant differences among groups. The study is published in the Journal of Refractive Surgery.
  • Fluorophotometry generally does not correlate with any other dry eye disease (DED) tests, even though it showed capability of differentiating between DED and normal eyes up to 30 minutes after fluorescein dye instillation, according to K. Fujitani and colleagues. Fifty eyes from 25 patients (DED=22 eyes, 11 patients; normal=28 eyes, 14 patients) were included in the group's prospective analysis. Baseline scans of the dry eye and control groups did not show any statistical difference (p=0.84). Fluorescein concentration of DED and normal patients showed statistical significance at all time intervals (p<10(-5), 0.001, 0.002, 0.049 for 5, 10, 15, and 30 minutes, respectively). Fluorophotometry values converged toward baseline as time elapsed, but both groups were still statistically different at 30 minutes (p<0.01). The investigators used 4 fluorophotometry scoring methods and correlated them with ocular surface disease index, tear break-up time, fluorescein, and lissamine along with adjusted and aggregate scores. The 4 scoring schemes did not show any significant correlations with the other tests, except for correlations seen with lissamine and 10 (p=0.045, 0.034) and 15 minutes (p=0.013, 0.012), and with aggregate scores and 15 minutes (p=0.042, 0.017). The study is published in BMC Ophthalmology.
  • Femtosecond laser astigmatic keratotomy (AK) significantly improved uncorrected (UDVA) and corrected (CDVA) distance visual acuities and significantly reduced keratometric astigmatism and refractive cylinder after keratoplasty, according to R.M. St. Clair and colleagues. At 3 academic medical centers, the researchers retrospectively reviewed 140 femtosecond laser AK procedures that were performed after penetrating keratoplasty (PKP) (n=129) or deep anterior lamellar keratoplasty (DALK) (n=11), with 89 procedures (80 PKP, 9 DALK) included in the analysis. The mean CDVA improved from 20/59 (0.47 logMAR±0.38 [SD]) preoperatively to 20/45 (0.35±0.31 logMAR) postoperatively (P=.013) (n=46). The mean keratometric astigmatism decreased from 8.26±2.90 D preoperatively to 3.62±2.59 D postoperatively (P<.0001) (n=89). The mean refractive cylinder decreased from 6.77±2.80 D preoperatively to 2.85±2.57 D postoperatively (P<.0001) (n=69). A nomogram for femtosecond laser AK to treat post-keratoplasty astigmatism was generated using regression analysis. The study is published in the Journal of Cataract & Refractive Surgery. 

NEW PRODUCT BRIEF

  • Diamatrix (The Woodlands, Texas) introduced the XpandNT single-use iris speculum, the company said. The XpandNT is now available in both single- and multi-use versions and both feature a biocompatible nitinol ring that is flexible and provides 6.7 mm of near circular, mechanical dilation.

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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