EW Weekly, February 21, 2020

Study: Universal Protocol could help prevent errors in ophthalmology surgery
Properly following Universal Protocol could help prevent most surgical confusion, according to a retrospective cohort study led by Ravi Parikh, MD, and coresearchers. They analyzed 143 cases of surgical confusion identified by the Ophthalmic Mutual Insurance Company from closed case files and by the New York State Health Department. Among those cases, 64.3% were described as preventable by Universal Protocol. Among all cases, 66.4% were incorrect IOLs used during cataract surgery, of which 34.7% were not preventable by Universal Protocol. Other causes of surgical confusion included wrong eye blocks or anesthesia (14%), incorrect eye procedures (7%), incorrect refractive surgery measurements (4.2%), incorrect patient or procedure (3.5%), incorrect intraocular gas concentration (2.8%), and incorrect medication in surgery (2.1%). An inadequately performed time out was the most common root cause of confusion, occurring in 32.2% of cases. Incorrect lens orders or calculations before surgery was the second most common surgical confusion cause (21.7%). The mean legal indemnity for incorrect IOL during cataract surgery, incorrect refractive surgery measurement, incorrect eye procedure, and incorrect gas concentration were $57,514, $123,125, $50,000, and $220,844, respectively. The study is published in Ophthalmology.

FDA approves Pataday for nonprescription use
The U.S. FDA has approved Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops 0.1%, Alcon) and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution drops 0.2%, Alcon) for over-the-counter (OTC) use. Geared toward the signs and symptoms of allergic conjunctivitis, Pataday Twice Daily Relief was first approved by the FDA in 1996, and Pataday Once Daily Relief was approved in 2004, both as prescription drugs. The drugs were approved for nonprescription use under a process called prescription-to-OTC switch, according to an FDA news release. Under the process, the manufacturer must show that consumers can understand how to use the drug safely and effectively without supervision from a healthcare professional, according to the FDA.

IOP reduction observed among OAG patients with OTX-TIC
In a Phase 1 clinical trial, meaningful IOP reduction took place over 18 months among patients with primary open-angle glaucoma (OAG) or ocular hypertension who used OTX-TIC (Ocular Therapeutix), according to a company news release. OTX-TIC is a long-acting travoprost intracameral implant designed to treat primary OAG or ocular hypertension. The Phase 1 prospective, multicenter, open-label, dose-escalation trial included two fully enrolled cohorts (five subjects in cohort 1 and four subjects in cohort 2). Mean IOP values remained lower from baseline values throughout the study. No serious adverse events were reported, and OTX-TIC was generally safe and well tolerated. The implant biodegraded consistently in about 5 to 7 months, according to the company. Company leaders are now enrolling third and fourth cohorts for the trial.

Beovu approved for wet AMD by the European Commission
Brolucizumab (Beovu, Novartis) has been approved by the European Commission to treat wet age-related macular degeneration, according to a company news release. The decision is applicable to all 27 European Commission member states and the U.K., Iceland, Norway, and Liechtenstein. The approval of Beovu was based on findings from the HAWK and HARRIER Phase 3 trials, which found that the drug showed gains in best corrected visual acuity that were non-inferior to aflibercept (Eylea, Regeneron Pharmaceuticals) at year 1. The vision gains achieved at year 1 were maintained at year 2.

Update provided from Phase 3 trial with emixustat for Stargardt disease
More than 65% of subject enrollment has been achieved with the ongoing Phase 3 clinical trial for emixustat (Acucela) for patients with macular atrophy secondary to Stargardt disease. As of Jan. 31, a total of 108 patients have been enrolled, with a target total of 162 across 30 sites in 11 countries this year. Trial enrollment can be challenging with a rare disease like Stargardt, the company reported. In the multicenter, randomized, double-masked, placebo-controlled trial, subjects will be randomly assigned to emixustat 10 mg or placebo (2:1) once a day for 24 months.

Research briefs
  • Compared with conventional retinal nerve fiber layer (RNFL) thickness, a segmentation-free deep learning algorithm performed better to help diagnose glaucomatous damage on spectral-domain (SD) OCT scans, according to a cross-sectional study of 1,154 eyes of 635 individuals, led by Atalie Thompson, MD. Researchers compared the area under the receiver operating characteristic curve and sensitivity at 80% or 95% specificity for the deep learning algorithm’s predicted probability of glaucoma compared with conventional RNFL thickness parameters given by SD-OCT software. Among the 20,806 images analyzed (53% with glaucoma and 47% normal eyes), the deep learning algorithm had a significantly higher area under the receiver operating characteristic curve than global RNFL thickness (0.96 vs. 0.87). At 95% specificity, the deep learning algorithm (81%) was more sensitive than global RNFL (67%). Among the eyes with glaucoma, 70.4% had perimetric glaucoma and 29.6% had preperimetric glaucoma. The study is published in JAMA Ophthalmology.
  • Even if there is no visible structural damage to the posterior capsule, prior intravitreal antivascular endothelial growth factor (VEGF) injections are significantly correlated with a higher risk for surgical posterior capsule rupture, according to Anindyt Nagar and coresearchers in their single-center, retrospective, electronic medical record database study. Researchers reviewed data from 4,047 eyes having phaco between Aug. 1, 2016 and Jan. 1, 2018. Among those, 2.7% (108 eyes) had previous anti-VEGF treatment. After excluding three eyes that had preop posterior chamber trauma, anti-VEGF treatment was associated with an increased risk of posterior capsule rupture compared with the group that did not have it (6.67% versus 1.88%, P<.001). A dose-dependent relationship was found between the number of anti-VEGF injections and the likelihood of rupture. The study is published in the Journal of Cataract & Refractive Surgery.
  • Wound sealing with intrastromal hydration was safer than air tamponade to preserve endothelial cell density and function during uneventful cataract surgery, according to Asimina Mataftsi and coresearchers. Their prospective, comparative, case-control series included patients assigned to receive anterior chamber air bubble (Group A) or intrastromal wound hydration with balanced salt solution (Group B) at the conclusion of surgery. Two high-volume surgeons used an identical surgical technique except for corneal side incision management. Researchers assessed patients preop and at days 1, 4, 9, 10, and 30 postop. Among the 100 eyes of 100 patients, the two groups were comparable for preop risk factor assessment, baseline central corneal thickness, preop endothelial cell density, and cumulative dissipated energy and phaco duration. Surgically induced astigmatism also was comparable. On day 1 postop, the mean central corneal thickness and best corrected visual acuity were better in Group B, but the results otherwise did not differ at other timepoints. At 1 month, endothelial cell loss was greater in Group A (34.06%) compared with Group B (16.45%). The study appears in Graefe’s Archive for Clinical and Experimental Ophthalmology.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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