EyeWorld Weekly Update, June 9, 2017

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June 9, 2017
Volume 22 , Number 22

Zepto Capsulotomy System receives 510(k) clearance from FDA

The Zepto Capsulotomy System (Mynosys Cellular Devices, Fremont, California) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for lens capsulotomy during cataract surgery. The Zepto can be used through a 2.2-mm incision; it can also provide personalized capsulotomies, according to a company press release.

Phase 3 results released from corneal collagen crosslinking study

One-year safety and efficacy data from a randomized, controlled pivotal Phase 3 clinical trial for Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution, Avedro, Waltham, Massachusetts), Photrexa (riboflavin 5'-phosphate dextran ophthalmic solution, Avedro), and the KXL System to treat progressive keratoconus show that treatment exceeded the primary efficacy endpoint of a 1 D difference in Kmax over 1 year. The Kmax improved by 1.6 D from baseline to 1 year in the crosslinking treated group and worsened by 1 D in the control group, for a difference of 1.6 D. Eyes that had crosslinking performed had a mean gain of 5.5 ETDRS letters over baseline corrected distance visual acuity (CDVA). That compares to a 2.2-letter gain in CDVA in the control group, according to an Avedro press release. There was one case of ulcerative keratitis reported in the trial (0.3%). The trial included 205 patients with keratoconus progression from 11 clinical sites across the U.S. Treatment group eyes had standard epithelium-off corneal crosslinking and Photrexa Viscous and Photrexa riboflavin and 3 mW/cm2 ultraviolet A (UVA) light; control group eyes received the treatment agents but did not have the epithelium removed and did not receive UVA light. Patients who had crosslinking performed also had improvements in visual function including night driving, reading, double vision, and glare, according to lead author Peter Hersh, MD. The research is published in Ophthalmology.

Ozurdex recommended for noninfectious posterior uveitis in the U.K.

The National Institute for Health and Care Excellence in the U.K. recommended that the NHS routinely use Ozurdex (dexamethasone intravitreal implant, Allergan, Dublin, Ireland) to treat noninfectious posterior uveitis. If the recommendation becomes final guidance, the agent will be a covered treatment option for patients with active noninfectious posterior uveitis. The drug is funded already in some parts of the U.K. but not others. The process of obtaining funding for Ozurdex is often time consuming, according to a press release.

RESEARCH BRIEFS

  • Corneal confocal microscopy can demonstrate axonal loss and increased dendritic cell density in patients with multiple sclerosis (MS), according to research from Gulfidan Bitirgen, MD, and fellow researchers. Their cross-sectional comparative study of 57 patients with MS and 30 healthy people assessed corneal subbasal nerve plexus morphologic features, corneal dendritic cell density, and peripapillary retinal nerve fiber layer thickness in patients with MS. Corneal subbasal nerve plexus features and dendritic cell density were quantified in images performed with laser scanning in vivo corneal confocal microscopy. Peripapillary retinal nerve fiber layer thickness was measured with spectral-domain OCT. Corneal confocal microscopy may be used as an imaging biomarker to identify axonal loss in MS patients, the researchers concluded. The study is published in JAMA Ophthalmology.
  • Greater physical activity is associated with lower odds of developing age-related macular degeneration (AMD), according to newly published research led by Myra McGuinness. Their systematic review and meta-analysis used Medline, EMBASE, and Google Scholar to search for studies related to physical activity and early and late AMD. Nine studies were included in the meta- analysis. Physical activity had a protective association with early AMD in eight studies and late AMD in seven studies. The studies focused on Caucasian populations. Although the results reinforce the importance of staying active, further longitudinal studies are needed to characterize the protective effect of physical activity, the researchers concluded. The study is published in the American Journal of Ophthalmology.
  • A long follow-up of 24 patients who had pterygium surgery with conjunctival graft found no recurrences of pterygium or complications when using upper conjunctival flap or lower conjunctival graft during surgery, according to Ofira Zloto and coauthors. They collected data from patients who had pterygium surgery by two surgeons at Goldschleger Eye Institute, Sheba Medical Center, Israel, between 1997 and 2001. Eleven of the 24 patients had a superior conjunctival flap, and 13 had an inferior conjunctival flap. There was one surgery for recurrent pterygium in group 1 and two in group 2. However, there was no recurrence of pterygium in either group, and no eye complications or side effects were found. A lower graft appears to be as good as an upper flap to prevent the recurrence of pterygium, the researchers concluded. The study appears in Contact Lens & Anterior Eye.
  • In mild, moderate, and high myopia, small incision lenticule extraction (SMILE, Carl Zeiss Meditec, Jena, Germany) had acceptable efficacy, safety, predictability, and stability, according to Magda Torky, MD, and coauthors. Their prospective case series divided eyes into a low myopia group (94 eyes; spherical equivalent [SE] refraction of -1 to -3 D), moderate myopia (95 eyes; SE of -3.25 to -6 D), and high myopia (85 eyes; -6.25 to -10 D). Outcomes were reported 6 weeks after SMILE. Significant improvements were seen in uncorrected and corrected distance visual acuities as well as sphere, cylinder, and SE. There were significant differences in postoperative uncorrected distance visual acuity, sphere, and SE between the low and moderate myopia groups and the high myopia group. However, researchers found no difference in the corrected distance visual acuity, cylinder, efficacy, or safety. There was a difference in attempted SE and achieved SE correction of 0.12 D in the low myopia group, -0.18 D in the moderate myopia group, and -0.60 D in the high myopia group. No statistically significant change in the postop SE was found in any group at 3 or 6 months. "The tendency toward undercorrection in the high myopia group suggests the need to modify the nomograms of small-incision lenticule extraction in highly myopia patients," the authors concluded. The research is published in the Journal of Cataract & Refractive Surgery.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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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