EyeWorld Weekly Update, December 8, 2017

December 8, 2017
Volume 23 , Number 42

Final module submitted for premarket approval of VisAbility Micro Insert System

The final module has been submitted to the U.S. Food and Drug Administration (FDA) for premarket approval of the VisAbility Micro Insert System (Refocus Group, Dallas) for presbyopia. The system is part of the first and only presbyopic procedure, according to a company press release, performed outside the eye's line of sight by inserting four micro-thin inserts just below the sclera surface. The procedure takes about 20 minutes, according to the company.

New patent issued for Glaukos innovations

The U.S. Patent and Trademark Office has issued Patent No. 9,827,143 to Glaukos (San Clemente, California). The patent, called "Shunt Device and Method for Treating Ocular Disorders," covers ocular devices and methods of surgically implanting devices at least partially within Schlemm's canal to facilitate aqueous humor flow. "This issued patent strengthens the protections of our inventions, further substantiates the proprietary nature of our technology, and further expands our portfolio of more than 200 patents issued in the U.S. and major international markets," said Thomas Burns, president and CEO of Glaukos, in a press release.

Phase 2 data for 0.5% reproxalap for non-infectious uveitis presented to the American Uveitis Society

New analyses of results of a randomized, multicenter, investigator-masked comparator-controlled, parallel-group Phase 2 clinical trial of topical ocular reproxalap (formerly known as ADX-102, Aldeyra Therapeutics, Lexington, Massachusetts) were presented to the American Uveitis Society at the 2017 American Academy of Ophthalmology (AAO) annual meeting. The analyses showed formal statistical non-inferiority of 0.5% reproxalap (P=0.036 after 2 weeks of therapy and P=0.048 after 4 weeks of therapy) compared to Pred Forte (prednisolone, Allergan, Dublin, Ireland) in reducing anterior chamber inflammatory cell count, which is commonly used as the non-infectious anterior uveitis clinical endpoint. Reproxalap therapy combined with twice-daily Pred Forte also was statistically non-inferior to Pred Forte monotherapy four times a day. Earlier this year, Aldeyra Therapeutics announced a Phase 3 trial for topical reproxalap in patients with non-infectious anterior uveitis. It is expected to enroll up to 100 patients.


  • Ophthalmologists in developed countries can reduce their material use and emissions from ophthalmic procedures following methods described by Cassandra Thiel, PhD, and co-researchers. Their observational case series measured the waste generation and lifecycle environmental emissions from phacoemulsification at two tertiary care centers that are part of the Aravind Eye Care System in India. They used manual waste audits, purchasing data, and interviews with Aravind staff to quantify environmental emissions associated with cataract surgery. They found that Aravind generates 250 grams of waste per phaco procedure and almost 6 kilograms of carbon dioxide-equivalents in greenhouse gases. This is about 5% of the U.K.'s phaco carbon footprint with comparable outcomes, according to the authors. Most of Aravind's lifecycle environmental emissions are in the sterilization process of reusable instruments. The use of electricity in the OR and the Central Sterile Services Department accounts for 10% to 25% of most environmental emissions. The research appears in the Journal of Cataract & Refractive Surgery.
  • Even though endothelial cell loss after Descemet's stripping automated endothelial keratoplasty (DSAEK) was greater with a longer cornea preservation time, the effect of preservation time on endothelial cell loss was comparable from 4 to 13 days of preservation time, according to Jonathan Lass, MD, and co-researchers. Their work, which is part of the Cornea Preservation Time Study, was a randomized clinical trial with 40 clinical sites and 70 surgeons. There were 945 eyes included from 769 participants, none of whom had experienced graft failure 3 years after DSAEK. Participants received a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. During the initial eye bank tissue screening, the mean central endothelial cell density was 2,746 cells/mm2 in the 0- to 7-day preservation time group and 2,723 cells/mm2 in the 8- to 14-day preservation time group. Longer preservation time was associated with lower endothelial cell density. The study is published in JAMA Ophthalmology.
  • A retrospective cohort study led by Chia-Yi Lee found that blepharitis was significantly related to metabolic syndrome and can serve as an early sign of metabolic syndrome. Investigators used data from the Longitudinal Health Insurance Database of Taiwan between 2009 and 2013 and focused on patients diagnosed with blepharitis (n=10,093). There was also an age-matched, gender-matched, and disease-matched control group (n=40,372). Based on conditional logistic regression, there was a higher cumulative probability of hyperlipidemia and coronary arterial disease; after adjustment, there was a higher probability of metabolic syndrome in patients with blepharitis compared with controls. Both hyperlipidemia and coronary artery disease were significantly correlated with blepharitis development, but hypertension, diabetes, and insulin resistance showed no correlation. The researchers recommend additional studies to examine the relationship between blepharitis and metabolic syndrome in terms of severity. The research appears in the British Journal of Ophthalmology.
  • In a study comparing surgically induced astigmatism among eyes with glaucoma, there was less induced astigmatism from the EX-PRESS shunt (Alcon, Fort Worth, Texas), ab externo trabeculotomy, and microhook ab interno trabeculotomy compared with trabeculectomy. The study included 80 right eyes of 80 subjects; each surgical group had 20 eyes. Researchers tracked best corrected visual acuity (BCVA), IOP, and keratometry before surgery and 3 months postoperatively via chart review. They also calculated the means of the vector magnitude, vector meridian, and arithmetic magnitude of the preoperative and postoperative astigmatism and surgically induced astigmatism. The mean astigmatic arithmetic magnitudes were not significantly different (P=0.0732) among the four groups, but the magnitude was significantly greater in the trabeculectomy group (P=0.0002). At 3 months postop, the surgically induced astigmatism correlated positively with the logMAR BCVA but negatively with the IOP. The research appears in Clinical Ophthalmology.
  • The Pascal Laser (Topcon Medical Systems, Oakland, New Jersey) received FDA clearance to offer Pattern Scanning Laser Trabeculoplasty to reduce IOP associated with glaucoma.
  • NovaTears + Omega-3 (Novaliq GmbH, Heidelberg, Germany) has been approved in Europe for enhanced treatment of signs and symptoms of evaporative dry eye disease. NovaTears + Omega-3 is the first eye drop to contain high concentrations of omega-3 (0.2%) ethyl ester of plant origin, according to a company release.

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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