EW Weekly, August 5, 2016

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August 5, 2016
Volume 21 , Number 27

CyPass granted U.S. approval

The Food and Drug Administration has granted regulatory clearance for the CyPass Micro-Stent, a microinvasive glaucoma surgery (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery, marketer Alcon (Fort Worth, Texas) said in a news release. The FDA approval is based on the landmark COMPASS study, the largest MIGS study to date with a two-year follow-up in more than 500 mild-to-moderate glaucoma patients undergoing cataract surgery. The primary effectiveness endpoint was met, with 73% in the CyPass Micro-Stent study group achieving a statistically significant decrease (≥ 20%) in intraocular pressure (IOP). The secondary effectiveness endpoint was also met, with 61% of patients achieving a target IOP (between 6 and 18 mm Hg) at the 24-month postoperative examination without medication.

3D OCT-1 Maestro granted U.S. approval

The Food and Drug Administration has granted regulatory approval for the 3D OCT-1 Maestro, a high-resolution color non-mydriatic retinal camera combined with spectral domain optical coherence tomography, developer Topcon (Oakland, New Jersey) said in a news release.

IRIS II granted CE mark

The IRIS II bionic vision system has been granted a CE mark by European regulators, developer Pixium Vision (Paris) said in a news release. The system comprises a 150-electrode epi-retinal implant design intended to be explantable and upgradeable, and is approved for people with vision loss from outer retinal degeneration. Additional studies on the device are ongoing in up to 10 patients suffering from retinitis pigmentosa, Usher syndrome, cone-rod dystrophy, or choroideremia who will be followed for a minimum of 18 months, with additional 18 months of follow-up.

P-321 enters Phase 2 study for dry eye

P-321, a potent inhibitor of the epithelial sodium channels (ENaC) on the ocular surface, is now in Phase 2 studies for the treatment of dry eye disease (DED), developer Parion Sciences (Durham, North Carolina) said in a press release. P-321 is expected to restore the tear film on the ocular surface in those patients with DED. Parion expects to enroll approximately 60 patients in the randomized, double-masked, parallel group study of P-321 Ophthalmic Solution compared to placebo in patients with DED over 28 days. The purpose of this study is to evaluate the effect of treatment with P-321 Ophthalmic Solution on dry eye symptoms. Patient enrollment has begun.

Positive top-line data from Tanzanite study for RVO continue

A 46-patient Phase 2 trial evaluating the treatment of macular edema associated with retinal vein occlusion (RVO) in treatment-nave patients has found an overwhelming majority of patients needed no additional treatments when administered Zuprata, a proprietary form of triamcinolone acetonide delivered suprachoroidally, and intravitreally administered aflibercept, developer Clearside Biomedical (Alpharetta, Georgia) said in a press release. Seventy-eight percent (18/23) of patients in the active arm of the TANZANITE trial did not require additional treatments during the three-month trial compared to 30% (7/23) in the aflibercept-only arm (p=0.003).

LASIK preferred to CLs over time

A new study finds contact lens (CL) users who chose to have LASIK were more satisfied with their vision a year after the surgery, and even more satisfied after two and even three years, according to Francis Price Jr., MD, and others with the Cornea Research Foundation of America. The study is the first to directly compare satisfaction rates of CL wearers (n=819) with those who opt for LASIK (n=694). Some key findings were: The proportion expressing strong satisfaction with CLs decreased from 63% at the start of the study to 54% at year three. Conversely, 88% of former CL users and 77% of former spectacle users reported being strongly satisfied with LASIK at year three, consistent with the high satisfaction levels at years one and two.

BPEI, Wills, Wilmer top list for best eye hospitals

According to its annual "Best Hospitals" rankings, U.S. News & World Report has named Bascom Palmer Eye Institute (BPEI, Miami) as the nation's best eye hospital, followed by Wills Eye (Philadelphia) and Wilmer (Baltimore).

RESEARCH BRIEFS

  • Ophthalmic viscosurgical device (OVD) use can affect the accuracy of intraoperative aberrometry because specific agents can alter the optical results and suggested IOL power, according to Samuel Masket, MD, Nicole Fram, MD, and Jack Holladay, MD. They divided eyes already scheduled for routine phacoemulsification surgery into six equal groups (n=120 eyes, 20 in each group), each receiving one of six different OVDs. After cataract removal, carefully controlled aberrometry was performed with the anterior chamber filled with balanced salt solution. Immediately thereafter, the balanced salt solution was replaced by one of the OVDs and the aberrometry repeated. The IOL power determination was lower with OVD filling the chamber. For DisCoVisc (Alcon, Fort Worth, Texas) and Amvisc Plus (Bausch + Lomb, Bridgewater, New Jersey), the mean absolute error (MAE) determinations were statistically different because the suggested IOL power was about 0.5 D less than with a balanced salt solution fill. For the remaining OVDs (Amvisc [Bausch + Lomb], Healon [Abbott Medical Optics, Abbott Park, Illinois], Healon GV [Abbott Medical Optics], and ProVisc [Alcon]), the MAE differences were insignificant. The strong correlation between differences in the index of refraction between balanced salt solution and specific OVDs appeared to be causal. The study is published in the Journal of Cataract & Refractive Surgery.
  • A population-based study of South Korean adults showed that low estimated glomerular filtration rate (eGFR) levels are independently associated with primary open-angle glaucoma (POAG), according to Seong Hee Shim, MD, and colleagues. They used a multistage, stratified, probability-clustered sampling method from the Korean National Health and Nutrition Examination Survey to evaluate 5,971 participants at least 40 years of age. The eGFR was calculated from serum creatinine concentrations using the Cockcroft-Gault formula, as follows: eGFR= (140−age) mass (kg) (0.85 for female subjects)/(72 serum creatinine (mg/dl). The presence of proteinuria also was assessed. The overall prevalence of POAG was 5.5%. The prevalence of low eGFR (<60 ml/min/1.73 m2) was 9.5%, and the prevalence of eGFR <45 ml/min/1.73 m2 was 2.0%. Multiple linear regression models revealed a positive correlation between the presence of POAG and low eGFR. No association was found between proteinuria and POAG. The study is published in Ophthalmology.
  • Descemet membrane endothelial keratoplasty tissues can be tri-folded (endo-in) with no significantly less cell loss as compared to endo-out, according to M. Parekh and colleagues. In their randomized, comparative, institutional, laboratory investigation of 18 human donor corneas, a total of 9.5 mm DMEK grafts were stripped and restored on the corneal base with a hinge and preserved in the deswelling medium. The corneas were mounted on an artificial anterior chamber (AAC) and four incisions made using a 15-degree eye knife for the side ports and slit knife to create a 3.0 mm incision for delivery of the graft into the AAC. The grafts with endothelium-in (endo-in) were pulled into a cartridge, whereas those with endothelium-out (endo-out) were aspirated using a modified Jones tube. Endothelial cell loss post-implantation was 10.532.82% with endo-in (n=9) compared to 7.56%14.74% with endo-out (n=9) (p>0.05). Preparation and unfolding time was 4.433.43 minutes and 0.961.10 minutes for endo-in compared to 1.680.57 minutes and 4.924.21 minutes for endo-out, respectively. A statistical significance between endo-in and endo-out for loading (p=0.04) and unfolding (p=0.023) time was observed. The study is published in Acta Ophthalmologica.

NEW PRODUCT BRIEFS

  • Bausch + Lomb (Bridgewater, New Jersey) introduced the Illuminated Directional Laser Probe, which combines the company's illuminated laser probe and directional laser probes. The new device adjusts from straight to a curve of 85 degrees, features a midfield illumination pattern, and is compatible with most modern ophthalmic light sources.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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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