EyeWorld Weekly Update, June 1, 2018

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June 1, 2018
Volume 24 , Number 19

First artificial iris approved for adults, children with congenital aniridia or iris defects

The first artificial iris for adults and children with congenital aniridia or iris defects due to conditions such as albinism, traumatic injury, or surgical removal due to melanoma has been approved by the U.S. Food and Drug Administration (FDA). The device, the CustomFlex Artificial Iris (HumanOptics, Erlangen, Germany), is surgically implanted and is made of thin, foldable, medical-grade silicone. In a clinical trial of 389 patients with aniridia or other iris defects, more than 70% had a significant decrease in light sensitivity and glare. Ninety-four percent were satisfied with the appearance of the artificial iris. The device was given a Breakthrough Device designation.

Spectralis OCT2 travels to International Space Station

The Spectralis OCT2 Module (Heidelberg Engineering, Heidelberg, Germany) is making its way to the International Space Station (ISS), according to a company press release. "NASA launched the Spectralis with OCT2 Module to the ISS aboard the Antares 230 Cygnus CRS OA-9, also known as Orbital Sciences CRS Flight 9E on May 21, 2018 from Wallops Island, Virginia. The device will be installed on the ISS in late 2018," according to the press release. Researchers from NASA have used Spectralis OCT to analyze the effects of a microgravity environment on vision since 2013, Heidelberg Engineering reported. Use of the OCT2 Module will optimize acquisition speed and capture more complex scans. It will also enable use of additional modalities, such as OCT angiography, anterior segment imaging, and ultra-widefield fundus imaging.

Omeros settles patient infringement suit with Lupin

Omeros Corporation (Seattle), maker of Omidria (phenylephrine and ketorolac intraocular solution) has entered into a settlement with Lupin Ltd. and subsidiary Lupin Pharmaceuticals (Stevensville, Maryland) to resolve Omeros' patent litigation against Lupin, according to an Omeros press release. The litigation was linked to Lupin's filing of an Abbreviated New Drug Application with the FDA to market a generic version of Omidria. The agreement with Lupin includes Lupin's acknowledgement and confirmation of the validity of all asserted patents for Omidria and overall terms and market entry date similar to that in settled litigation between Omeros and Par Sterile Products/Par Pharmaceuticals (Dublin, Ireland) from earlier this year. October 23, 2033 is the expiration date of the last-to-expire of Omeros' asserted patents.

Valuable YES education available at the 2018 Combined Ophthalmic Symposium

Register now for the Young Eye Surgeons (YES) Program at the 2018 Combined Ophthalmic Symposium, August 24-26 in Austin, Texas. The YES Program, designed specifically for residents and fellows, will be held on August 24, from 9:00 a.m.-5:30 p.m. YES Program attendees are also encouraged to attend the Ophthalmologist Program, on August 25 from 8:00 a.m.-5:30 p.m. and August 26 from 8:00 a.m.-12:30 p.m.
Featuring 3 hours of dedicated lab time, a 2-hour general session and 1-hour roundtable breakouts, the program will cover topics including:
  • Approaching the Routine Cataract Patient from Start to Finish
  • Patient Selection
  • Biometry, Astigmatism and Interpretation of Topography
  • Lasers and Lenses
  • Cataract Surgery in Complex Eyes
  • Rings, Hooks and More
  • Introduction to MIGS
  • Roundtable Discussions
  • Skills Transfer Labs
The 2018 program chairs are Sumit "Sam" Garg, MD, and Sumitra Khandelwal, MD. They are joined by expert faculty who will deliver high-quality education.

RESEARCH BRIEFS

  • Cataract surgery can be safely performed and have vision-restorative outcomes in patients with Ebola virus disease who test negative for Ebola virus RNA in ocular fluid specimens, reported J.G. Shantha and coresearchers. Those with Ebola virus are at risk for uveitis and cataract formation. The cross-sectional study anticipated active uveitis to evaluate Ebola virus RNA persistence in ocular fluid; patients with aqueous humor that tested negative for Ebola virus RNA were able to proceed with manual small incision cataract surgery. Among those who were screened, 50 Ebola virus disease survivors were enrolled, including 46 with visual significant cataract, one with a subluxated lens, two with active uveitis, and one with a blind painful eye due to uveitis. The median logMAR visual acuity was 3.0. All patients were negative for Ebola virus RNA by reverse transcription-polymerase chain reaction in aqueous humor/vitreous fluid and conjunctiva at a median of 19 months. Manual small incision cataract surgery was performed in 34 patients with a median visual acuity improvement from hand motions preoperatively to 20/30 at 3 months. The findings may help thousands of West African Ebola virus disease survivors who may need eye surgery, the researchers concluded. The study appears in EBioMedicine.
  • The ocular parameters observed at baseline and at 1 month after cataract surgery were important predictors of persistent dry eye symptoms postoperatively, concluded Young Joon Choi, MD, and fellow researchers. They enrolled 116 eyes of 116 patients who had uneventful cataract surgery with no previous ocular comorbidities. Prospective assessments included lipid layer thickness, meibomian gland dropout, tear breakup time, Oxford staining score, and other factors. Patients with an Ocular Surface Disease Index (OSDI) score of 12 or higher at 3 months after surgery were classified as having persistent dry eye symptoms after cataract surgery. Among the 96 patients who completed all exams through 3 months, 31 had persistent dry eye syndrome. Risk factors for persistent dry eye symptoms after cataract surgery included baseline high OSDI scores and 1-month postop low tear breakup time, low meibomian gland orifice obstruction scores, and increased meibomian gland dropout. The study is published in Cornea.
  • There were no statistically significant differences among transplant groups in a retrospective cohort study that analyzed the risk of glaucoma surgery after corneal transplant surgery in a group of Medicare patients. Led by Chengjie Zheng, MD, researchers used a 5% random sample of Medicare beneficiaries during the study time period and identified patients with Current Procedural Terminology codes for penetrating keratoplasty, endothelial keratoplasty, anterior lamellar keratoplasty, and keratoprosthesis. There were 3,098 patients who had corneal transplants during the study period; glaucoma surgery rates ranged from 6.1% to 9.4%; there were no statistically significant differences among groups. Ten percent of patients with preexisting glaucoma required glaucoma surgery after transplant surgery compared with 5.3% of patients without preexisting glaucoma. This also included 12.4% of penetrating keratoplasty patients with preexisting glaucoma compared with 2.8% of patients without preexisting glaucoma. The study appears in the American Journal of Ophthalmology.
  • The use of multifocal IOL implantation after corneal refractive laser surgery for hyperopia resulted in good visual acuity and refraction, according to Violette Vrijman, MD, and coresearchers. Their retrospective case series analyzed results 3 months after implantation of a multifocal IOL in patients after previous corneal refractive laser surgery for hyperopia. Among 40 eyes of 40 patients, 16 (40%) had lens extraction due to cataract, and 24 eyes (60%) had refractive lens exchange. The mean postop uncorrected distance visual acuity was 0.16 logMAR; mean postop corrected distance visual acuity was 0.01 logMAR. The mean postop spherical equivalent was 0.04. Twenty-five eyes (62.5%) were within ±0.50 D of emmetropia; 87.5% were within ±1 D of emmetropia. A laser enhancement was performed in nine eyes (22.5%) due to residual refraction error. Eleven eyes (27.5%) had a neodymium:YAG laser capsulotomy because of posterior capsule opacification. 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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