EW Weekly, August 23, 2019

Enrollment completed in trial of IC-8 small-aperture IOL
AcuFocus has completed enrollment in its pivotal U.S. Investigational Device Exemption (IDE) trial of the IC-8 small-aperture IOL, according to a company press release. The U.S. FDA approved the company’s IDE in November. Enrollment in the trial began shortly after the FDA approval. The IC-8 is a clear monofocal lens with an embedded pinhole in the center. The 12-month prospective, multicenter, non-randomized case control study will assess achieved vision improvement at all distances with the lens compared with traditional monofocal IOLs. Patients with bilateral cataracts assigned to the study group have received a contralateral implantation with the IC-8 and a monofocal or monofocal toric IOL; control group patients have received bilateral monofocal or monofocal toric IOLs. The IOL is on track for potential U.S. market entry in the fourth quarter of 2020 or first quarter of 2021, according to the company.

First-in-human trial begins for AR-13503 sustained release implant for AMD, DME
The first-in-human trial is underway for the AR-13503 Sustained Release (SR) Implant (Aerie Pharmaceuticals) for patients with neovascular age-related macular degeneration (AMD) or diabetic macular edema (DME), according to a company press release. The 24-week study has two phases, with the first phase a multicenter, open-label, dose-escalation study of a single intravitreal injection of the implant, using two doses, in up to 12 patients. The second phase will include up to 90 patients and is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose AR-13503 SR Implant dosed as monotherapy and in combination with aflibercept (EYLEA, Regeneron Pharmaceuticals) compared with aflibercept alone, the company reported. The implant is a bioerodible polymer implant that provides controlled release of AR-13503, a small-molecule inhibitor of Rho kinase and protein kinase C over a sustained period.

Technology under development that provides optic nerve stimulation for the blind
A group of scientists in Switzerland and Italy have technology in development for the blind that bypasses the eyeball and sends messages to the brain by stimulating the optic nerve with an intraneural electrode called OpticSELINE, according to a press release. The concept has been successfully tested in rabbits with results recently reported in Nature Biomedical Engineering.
With current electrode technology, a human OpticSELINE may have up to 48 to 60 electrodes, which is not sufficient to fully restore sight but could be engineered to provide a visual aid for daily living, the study authors report.

Study: Similar results reported for oral and intravenous sedation for cataract surgery
In a randomized, prospective, double-masked clinical trial, oral sedation was noninferior compared with intravenous sedation for cataract surgery in a diverse patient population, according to Crandall Peeler, MD, and coresearchers. They used a volunteer sample of 85 adult patients scheduled for cataract surgery who were randomized for oral triazolam with intravenous placebo or intravenous midazolam with oral placebo preoperatively. The primary outcome was patient satisfaction on postop day 1. The mean satisfaction score was 5.34 in the oral sedation group and 5.40 in the intravenous group. There was similar surgeon and anesthesia provider satisfaction between the two groups. Intraop complications occurred in 16.7% of the oral group and 9.3% of the intravenous group. Supplemental intravenous sedation was given to 19% of patients in the oral group and 7% in the intravenous group. The study is published in Ophthalmology.

Research briefs
  • A survey of 247 European surgeons focused on attitudes and beliefs toward immediate sequential bilateral cataract surgery (ISBCS) found that 67.2% performed ISBCS and 28.7% did not. Four percent had previously performed it but stopped, reported E.C. Mills, BSc, and coresearchers. For those performing ISBCS, the three most important factors for respondents were all related to infection risk. For those who did not perform ISBCS at all, the risk of endophthalmitis (69%) and medicolegal issues (57.8%) were the biggest factors. The most common reason that some surgeons had stopped performing ISBCS is they no longer believed in its benefits. The survey findings could be used to inform service provision of ISBCS in the U.K., taking into consideration the voices of colleagues overseas, the authors concluded. The study is published in the Journal of Cataract & Refractive Surgery .
  • Both azithromycin 1.5% drops and oral doxycycline significantly improved signs and symptoms of moderate to severe meibomian gland dysfunction (MGD), according to Vannarut Satitpitakul and coresearchers. Their prospective, randomized trial included 169 participants with newly diagnosed MGD who were randomly assigned to treatment with azithromycin 1.5% (n=85) twice a day for 2 days, then once a day for up to 4 weeks or oral doxycycline (n=84) 100 mg twice a day for 4 weeks. The primary outcome was the percentage of patients with meibum quality improvement. Both groups had significant improvements, and there were no between-group differences in the percentage of participants with improved meibum quality (P=0.80), MGD-related symptoms (P>0.05), meibum expressibility (P=0.92), Oxford ocular staining score (P=0.59), and tear breakup time (P=0.99). Both groups had a similar number of patients (five in the azithromycin group and four in the doxycycline group) who discontinued their medication due to drug side effects. The study is published in Graefe’s Archive for Clinical and Experimental Ophthalmology .
  • When comparing the single application and 2-week treatment effects of device-applied (Eyepeace eyelid massager) and manually applied eyelid massage techniques as an adjunct to warm compress therapy in patients with MGD, the device had marginally greater improvement, reported MTM Wang and coresearchers. The difference was statistically but not clinically significant. The investigator-masked, randomized, contralateral eye trial included 20 participants with dry eye symptoms. After 10 minutes of warm compress therapy application on both eyes, eyelid massage therapy was applied to one eye by the device and to the fellow eye with manual massage. Immediate post-treatment improvements in tear film stability were observed in both groups, but no significant long-term cumulative effects or inter-treatment differences in stability measures were detected. Parallel group trials with longer treatment periods are needed, the researchers concluded. The study appears in Contact Lens & Anterior Eye .
  • More health literacy research is needed in the field of retinal diseases, according to Sofie Jandorf and coresearchers, who conducted a cross-sectional questionnaire study that used the validated European Health Literacy Survey (HLS-EU-Q16) questionnaire to determine the health literacy of 225 patients with AMD, DME, or retinal vein occlusion. All of the patients received intravitreal treatment at a retinal clinic in Denmark. Although health literacy levels did not differ significantly among the groups, the proportion of patients with poor health literacy was high—65% in the AMD group, 73% in the DME group, and 63% in the retinal vein occlusion group. Better health literacy can help ensure that patients have timely and appropriate knowledge and competencies to manage their condition, the researchers concluded. The study is published in BMC Ophthalmology .

    Product news
  • New World Medical released the Ahmed ClearPath glaucoma drainage device, available in two sizes, 350 mm2 and 250 mm2. The implant is a flexible plate with a contour that closely conforms to the eye's curvature, and the suture fixation points are positioned more anteriorly on the device compared to other valveless drainage devices, according to New World Medical.

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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