EW Weekly, May 31, 2019

iStent inject combined with cataract surgery has better results than cataract surgery alone
Compared with cataract surgery alone, use of the iStent inject (Glaukos) combined with cataract surgery led to clinically and statistically greater IOP reductions without medication and had excellent safety, reported Thomas Samuelson, MD, and fellow researchers in their prospective, randomized, single-masked, multicenter clinical trial published in Ophthalmology. The researchers randomized eyes 3:1 intraoperatively after uneventful cataract surgery to ab interno implantation of the iStent inject (n=387) or no stent implantation (n=118). All patients had mild to moderate primary open angle glaucoma. Subjects were followed for 2 years. The endpoints were a 20% or more reduction from baseline in month 24 unmedicated diurnal IOP and the change in unmedicated month 24 diurnal IOP from baseline. Various safety measures were assessed, including complications and adverse events. At 24 months, a 20% or more reduction from baseline in unmedicated diurnal IOP occurred in 75.8% of treatment eyes versus 61.9% of control eyes. The mean reduction in unmedicated diurnal IOP from baseline was larger in the treatment eyes. At 23 months, among responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication. Safety was favorable and similar between the two groups.

Glaucoma eye drop side effects affect adherence in patient-reported study
Use of preservative-free drops and a reduction in eye drop related side effects could help improve adherence to glaucoma eye drops, reported Christian Wolfram and coresearchers in their study that focused on self-reported nonadherence to glaucoma eye drops among 201 adult patients. Participants in their study completed a 16-item questionnaire. The study defined nonadherence as missing 5% or more of the prescribed IOP-lowering drops. The mean treatment duration was 9.4 years. Approximately 30% of participants said they were nonadherent. Those who experienced side effects reported higher levels of nonadherence than those who did not (37.6% versus 18.4%; P=0.004). About 84% of participants used eye drops with preservatives, 11.9% were on combined preservative and preservative-free treatments, and 4% were on preservative-free medication only. In each of those groups, self-reported nonadherence levels were 32%, 25%, and 12.5%, respectively. Men had higher levels of self-reported nonadherence compared with women (36.8% versus 24.5%; P=0.066); age, social status, history of migration, disease severity, and fear of blindness were not associated with significant differences in adherence. “The patient experience should be a key consideration when selecting appropriate treatments, to reduce nonadherence and optimize outcomes,” the researchers concluded. The study is published in the Journal of Ocular Pharmacology and Therapeutics.

Study: Vision impairment and depression/anxiety bidirectionally linked
Symptoms of depression were more likely to be reported at a later date by older U.S. adults with self-reported vision impairment; additionally, those with depression and anxiety were more likely to report vision impairment in the future, according to Charles Frank, BS, and coresearchers, in a study published in JAMA Ophthalmology. The 5-year cohort study included 7,584 Medicare beneficiaries with self-reported vision impairment status information. In patients with self-reported vision impairment, depression symptoms and anxiety symptoms were significantly more common. Depression and anxiety symptoms at baseline were both significantly associated with future reports of self-reported vision impairment. “This investigation suggests that there is a significant bidirectional and longitudinal association between self-reported vision impairment and mental health symptoms,” the researchers wrote. Effective strategies to screen for and address depression among older U.S. adults with vision impairment are needed, the researchers concluded.

DEXTENZA has new reimbursement code from CMS
The Centers for Medicare and Medicaid Services has approved transitional pass-through payment status and has established a new reimbursement code for DEXTENZA (dexamethasone ophthalmic insert, Ocular Therapeutix), according to a company press release. The new code is C9048 and is scheduled to become effective on July 1.

Research briefs
  • In a study focusing on the accuracy of IOL power calculation formulas in Chinese eyes with axial lengths longer than 26 mm, incidence of a hyperopic outcome with the Wang-Koch AL adjustment formula was significantly smaller than with other formulas, reported Jiewei Liu, MD, and fellow researchers. The study included 136 eyes and evaluated the Barrett Universal II and Hill-RBF 2.0 formulas as well as three vergence formulas (Haigis, Holladay 1, and SRK/T) and the original and modified Wang-Koch AL adjustment formulas with Holladay 1 and SRK/T. The refractive prediction error was calculated by subtracting the predicted refraction from the actual refraction after surgery. The Barrett and Hill-RBF formulas had mean numerical errors close to zero, while the Haigis, Holladay 1, and SRK/T produced hyperopic mean numerical errors. The original and modified Wang-Koch AL formulas induced myopic mean numerical errors. There were no significant differences in mean absolute errors among the Barrett, Hill-RBF, Haigis, and original and modified Wang-Koch adjustment with the Holladay 1. The study is published in the Journal of Cataract & Refractive Surgery.
  • A therapeutic potential was found with recombinant deoxyribonuclease eye drops 0.1% for severe tear deficient dry eye disease in a Phase 1/2 placebo-controlled, randomized pilot clinical trial, according to Christine Mun and coresearchers. The drops were given four times a day for 8 weeks. Changes in safety outcome measures such as drug tolerability and proportion of adverse events and efficacy outcome measures (Ocular Surface Disease Index [OSDI] score and cornea and conjunctival staining) were measured. There was similar tolerability and adverse event occurrence between the treatment and placebo groups. Corneal staining showed a significant and clinically meaningful reduction at 8 weeks compared with baseline in the treatment group, and the OSDI score had a significant median reduction of 27.3. The median reduction in corneal staining and mucoid debris/strands was significantly greater in the deoxyribonuclease group compared with placebo. The study is published in Translational Vision Science & Technology.
  • The use of autologous serum eye drops resulted in significant clinical improvement in dry eye disease management in a retrospective observational study of 50 patients (87 eyes), reported N. Levy and coresearchers. The patients in the study had dry eye disease refractory to conventional treatment and had an OSDI score of 20 or higher. Each treated eye had eight or more daily drops of 20% autologous serum. Researchers performed extensive biological characterization of undiluted serum, and symptoms were recorded before use of the drops and closer to the sixth month of treatment. Among patients, 68% were responders. Researchers described responders as presenting an improvement from baseline of 14 points or more on the OSDI and a 1 or greater grade of improvement in corneal fluorescence staining. The OSDI and Oxford scale significantly reduced from 68.7 to 54.8 and 3.2 to 2.1, respectively. Nonresponding patients had significantly higher epidermal growth factor concentrations in the serum compared to responders (P=0.017). The study is published in The Ocular Surface/

Product news

  • The LacryStim IPL system for dry eye (Quantel Medical) has received a CE mark. Based on intense pulsed light, it is used to treat dry eye diseases such as meibomian gland dysfunction, according to the company.

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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