EyeWorld Weekly Update, March 16, 2018

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March 16, 2018
Volume 24 , Number 9

Pivotal U.S. Phase 3 trial announced for epi-on crosslinking for progressive keratoconus patients

A pivotal Phase 3 clinical trial for epithelium-on (epi-on) corneal collagen crosslinking (CXL) to treat patients with progressive keratoconus was announced by Avedro (Waltham, Massachusetts). The company reached an agreement this week with the U.S. Food and Drug Administration (FDA) regarding the design of a Special Protocol Assessment for the trial. The Phase 3 trial, called KXL308, is a multicenter, randomized, controlled study using an accelerated corneal CXL procedure with oxygen compared to controls in an estimated 275 subjects with progressive keratoconus. There will be a 1-year follow-up with patients. Study locations will be available at clinicaltrials.govonce study enrollment begins, according to a company press release.

SightLife Surgical acquires the KAMRA inlay

SightLife Surgical (Irvine, California) has agreed to terms for acquisition of the KAMRA inlay (AcuFocus, Irvine, California). The KAMRA is the leading corneal inlay around the world and was the first to receive U.S. FDA approval for presbyopic surgical correction, according to a press release. To assist with the transition, a core team from AcuFocus will join SightLife Surgical. The deal should be finalized by the end of the first quarter of this year, and a full transition of services and support should follow after that, the company reported.

IDE submitted to U.S. FDA for second pilot study of ocular bandage gel

EyeGate Pharmaceuticals (Waltham, Massachusetts) submitted an amended Investigational Device Exemption (IDE) application to the U.S. FDA for a pilot study of its EyeGate Ocular Bandage Gel (EyeGate OBG), which is a crosslinked thiolated carboxymethyl hyaluronic acid platform. The amendment addresses the FDA's questions and comments in response to the original IDE submission. EyeGate OBG is under development for the acceleration of the reepithelialization of large corneal epithelial defects in patients who have had photorefractive keratectomy (PRK), according to a company press release. The amendment also includes validation data on the manufacturing processes and bioburden tests related to EyeGate OBG. The proposed IDE submission for the pilot study would enroll 45 subjects having a bilateral PRK procedure in a reading center masked trial. The trial compares EyeGate OBG to the current standard of care, which is a bandage contact lens and artificial tears.

Human adjudication helps to reduce errors in diabetic retinopathy grading

The use of adjudication reduces errors in diabetic retinopathy (DR) when a machine learning model is used, according to Jonathan Krause, PhD, and co-researchers. Their retrospective analysis focused on adjudication to quantify diabetic retinopathy errors based on individual graders and majority decision and to train an improved automated algorithm for DR grading. Images were graded by the algorithm, U.S. board-certified ophthalmologists, and retinal specialists. Among the 193 discrepancies between adjudication by retinal specialists and the majority decision of ophthalmologists, missing microaneurysms (36%), artifacts (20%), and misclassified hemorrhages (16%) were the most common. For moderate or worse DR, there was a sensitivity of 0.838 and a specificity of 0.981 for the majority decision of ophthalmologists. The algorithm had a sensitivity of 0.971, a specificity of 0.923, and an area under the curve (AUC) of 0.986. There was a sensitivity of 0.970, specificity of 0.917, and an AUC of 0.986 for the algorithm for mild or worse DR. However, using a small number of human-adjudicated consensus grades as a tuning dataset and higher resolution images as input, the algorithm improved and was on par with that of ophthalmologists and retinal specialists. The research appears in Ophthalmology.

RESEARCH BRIEFS

  • Medicare patients with smaller social support networks were less likely to have cataract surgery when they needed it, reported Brian Stagg, MD, and coauthors in their retrospective cohort study. Researchers reviewed patients from the National Health and Aging Trends Study that was administered annually from 2011 to 2015 to a cohort of Medicare beneficiaries who were age 65 or older and had no previous cataract surgery. A multivariable logistic regression was performed to evaluate if the number of people in a social support network influenced if that person received cataract surgery during a given study year. They found that Medicare beneficiaries with a social support network of zero to two individuals were less likely to receive cataract surgery in a given year compared with those of a support network of three or more individuals. Attention should be given to patients with smaller support networks to make sure they receive cataract surgery when needed, the authors concluded. The study appears in JAMA Ophthalmology.
  • Pterygium recurrence after amniotic membrane regrafting (AMG) is more common in Hispanic and black patients compared with after conjunctival autografting (CAG). In their retrospective review, Giovanni Campagna, BS, and co-researchers analyzed information from patients with primary pterygium excision with CAG or AMG. Average time to recurrence was 4.4 months and was similar between races (P=0.98). Recurrence rates were significantly different among whites (13%), Hispanics (28%), blacks (33%), and Asians (0%) (P=0.049). A significant difference in cumulative proportion with recurrence after AMG versus CAG was noted in Hispanic (75% versus 30%) and black (100% versus 42%) patients over a year. However, sex, graft fixation method, and surgeon training level showed no difference in pterygium recurrence. The study appears in Cornea.
  • Tissue manipulation may be more uncomfortable during small incision lenticule extraction (SMILE) compared with LASIK, but subjective visual symptoms were comparable after 3 months in a prospective, randomized, paired-eye, single-masked clinical trial with 70 patients. Iben Damgaard, MD, and co-researchers used an intraoperative questionnaire with patients to measure light perception, anxiety levels, fear, and discomfort. Patients also completed a questionnaire at 1 and 3 months that addressed light sensitivity, eye discomfort, eye dryness, excessive tearing, gritty sensation, and other factors. The mean discomfort scores were higher with SMILE's tissue manipulation than with flap lifting in LASIK. However, they were comparable during docking and laser application. Scores of fear were lower with SMILE than with LASIK during docking, but those scores were similar during occasional blackout, laser application, and lenticule/flap manipulation, the authors reported. Although blurring was more common at 1 month with SMILE than with LASIK, there were no differences in visual symptoms at 3 months. The research is published in the Journal of Refractive Surgery.
  • More advanced wound construction in manual small incision cataract surgery (SICS) may be more technically challenging for surgeons who are unfamiliar with it, but it was safe and efficacious in the hands of residents learning how to perform it, reported Ross Lynds, MD, and coauthors. Their research analyzed the use of manual SICS in selected cases for which phaco was thought to be more challenging, such as for mature or brunescent cataracts, traumatic cataracts, pseudoexfoliation syndrome, and other zonule weakness causes. Researchers reviewed all manual SICS performed by residents over a 5-year period. Of the 52 cases, the mean preop visual acuity was 2.165 logMAR, which improved to 0.278 logMAR postop. The most frequent intraop complications were iris prolapse (9.6%) and zonular dialysis (7.7%). The most common postop complications were cystoid macular edema (5.8%), retained ophthalmic viscosurgical device (3.8%), IOL displacement (3.8%), and microhyphema (3.8%). Manual SICS should play a role in modern cataract surgery because of its lower cost and its ability to remove dense nuclei, the authors concluded. The research appears in the Journal of Cataract & Refractive Surgery.
PRODUCT NEWS
  • The U.S. FDA approved the Next-Generation Compact Touch Ophthalmic Ultrasound Platform (Quantel Medical, Bozeman, Montana). Improvements include a new 15 MHz B probe, DICOM compatibility, WiFi and Bluetooth connectivity, and HDMI video output.

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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