EyeWorld Weekly Update, March 2, 2018

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March 2, 2018
Volume 24 , Number 7

Artificial intelligence-based system to detect DR achieves study endpoints

The IDx-DR (IDx, Iowa City, Iowa), a device that uses artificial intelligence to detect diabetic retinopathy (DR), met its endpoints in a pivotal U.S. Food and Drug Administration (FDA) study with 900 people who have diabetes. The trial took place at 10 primary care sites across the U.S. to evaluate the IDx-DR's diagnostic accuracy to detect moderate to severe diabetic retinopathy, including macular edema. The system detected more-than-mild DR at a sensitivity of 87.2% and a specificity of 90.7%. The results were presented at the recent Macula Society Meeting in Beverly Hills, California. The IDx-DR is designed to assess for diabetic retinopathy during visits with primary care providers. The system has been under FDA review since January; the company's submission was granted expedited review through the FDA's Breakthrough Devices Program.

International study of AMD progression launched by NIH/NEI

The National Institutes of Health's National Eye Institute (NEI) has announced a clinical study that will follow 500 people for 5 years to discover more about the natural history of age-related macular degeneration (AMD). Researchers hope the study will help identify disease progression biomarkers. Called the AMD Ryan Initiative Study, or ARIS, it will track the eye health of 200 people with bilateral early AMD; 200 people with early, reticular pseudodrusen; and 100 age-matched, drusen-free control participants. The study will take place at 20 sites; researchers will track drusen volume changes and other findings on spectral domain OCT. Researchers also would like to analyze the participants' DNA to search for correlations between genes and AMD progression, according to an NEI press release. For more study information, visit clinicaltrials.gov and search for NCT03092492.

Agent for viral conjunctivitis will go toward Phase 2 trial

OKG-0301 (Okogen, San Diego), developed for viral conjunctivitis, has received $10 million in Series A funding from Brandon Capital's Medical Research Commercialization Fund. The funding will be used to support the drug's clinical development plan, which includes the initiation of a Phase 2 clinical trial before the end of 2018, Okogen CEO Brian M. Strem said in a press release. OKG-0301 is an ophthalmic formulation of ranpirnase. There are currently no approved therapies for viral conjunctivitis, according to the company press release.

DISCOVER study reports on usefulness of intraoperative OCT

The DISCOVER iOCT (Determination of Feasibility of Intraoperative Spectral-Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery) study found a potential value and impact of microscope-integrated intraoperative OCT on ophthalmic surgery, according to Justis P. Ehlers, MD, and coresearchers. Their prospective, consecutive case series included 837 eyes (244 anterior segment cases and 593 posterior segment cases) undergoing iOCT imaging with 1 of 3 prototype microscope-integrated iOCT systems. Successful image acquisition occurred in 820 eyes (98%). In 106 anterior segment cases (43.4%), the iOCT information assisted with surgical decision-making and altered the procedure. Surgical decision-making was altered in 173 (29.2%) of the posterior segment procedures. The study appears in Ophthalmology.

ASCRS webinar "Identifying and Managing Progression in Keratoconus/Keratectasia: Pre and Post CXL" on Wednesday, March 14

Register now for the upcoming webinar "Identifying and Managing Progression in Keratoconus/Keratectasia: Pre and Post CXL," taking place Wednesday, March 14 at 9 p.m. EDT. Sponsored by the ASCRS Cornea Clinical Committee, attendees will learn from the experts about crosslinking (CXL) protocols and management, including how to define the progression of keratoconus, when to retreat a patient with suspected progression after CXL, and when to refer to a cornea specialist. Please join moderator Clara C. Chan, MD, panelists William B. Trattler, MD, and Kenneth A. Beckman, MD, and facilitator Marjan Farid, MD, for an interactive, case-based discussion.

RESEARCH BRIEFS

  • One-year treatment outcomes in the Primary Tube Versus Trabeculectomy Study found that trabeculectomy with mitomycin C (MMC) had a higher surgical success rate than tube shunt implantation. Additionally, trabeculectomy with MMC led to a lower IOP and the use of fewer glaucoma medications. The multicenter, randomized clinical trial included 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery (125 in the tube group and 117 in the trabeculectomy group). Patients were enrolled at 16 clinical centers and randomly assigned to receive a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with MMC (0.4 mg/ml for 2 minutes). Researchers, led by Steven J. Gedde, MD, found a cumulative probability of failure of 17.3% during the first year of follow-up in the tube shunt group and 7.9% in the trabeculectomy group. The mean IOP was 13.8 mm Hg in the tube group at 12.4 mm Hg in the trabeculectomy group at 1 year; the number of glaucoma medications used was 2.1 in the tube group and 0.9 in the trabeculectomy group. Twenty-nine percent of patients in the tube group had postop complications, compared with 41% in the trabeculectomy group. Serious complications that required reoperation or that produced a loss of two Snellen lines or more took place in one patient in the tube group and in eight patients (7%) in the trabeculectomy group. The study is published in Ophthalmology.
  • A comparison of three tear supplements for dry eye disease found that carboxymethylcellulose-glycerine-castor oil (CGC) had the greatest reduction of ocular inflammation biomarkers, but all three supplements reduced symptoms and improved tear stability, according to Eilidh Martin and coresearchers. The masked, randomized, three-way crossover trial included 18 subjects with dry eye. Researchers evaluated tear evaporation rate, stability, and osmolarity and analyzed tear samples for seven inflammatory markers. The three treatments included CGC, carboxymethylcellulose (CMC), and hydroxypropyl guar (HPG). Both CGC and HPG drops are emulsified liquids, the researchers reported; CGC also contains osmoprotectants. There were significant improvements in symptoms and tear stability at 4 weeks with all treatments; with CGC use, there was a more than 25% reduction in six out of seven biomarkers in 40% of subjects. The same reduction was seen in 10% of subjects using CMC and in none of the subjects using HPG. The study is published in Cytokine.
  • The use of topical tacrolimus 0.05% as an adjunct to steroids can speed up the resolution of endothelial rejection of a penetrating keratoplasty (PKP) graft, reported Mohammad Nasser Hashemian, MD, and coauthors. It also can potentially lower the recurrence of rejection. However, topical tacrolimus may not improve rejection reversal success, according to their study with 31 eyes of 31 patients. The study included patients with a clinical diagnosis of acute endothelial rejection of a PKP graft and randomized them into two groups: Group 1 received topical tacrolimus 0.05% as adjuvant therapy to corticosteroids and Group 2 received only corticosteroids. The main outcome measures were rejection reversal, time to rejection reversal, and rejection recurrence. The rejection episode resolved in 88.2% of patients in Group 1 and 85.7% of patients in Group 2. The time to resolution of rejection was significantly shorter in Group 1 than Group 2 after researchers adjusted for preop factors using the inverse-probability weighting method. Group 2 had a significantly higher recurrence rate of rejection. The research appears in Cornea.
  • Although the postop course between wet AMD after femtosecond laser-assisted cataract surgery (FLACS) and conventional cataract surgery was equal, FLACS-treated eyes had less subclinical macular edema in an early follow-up, reported Tim J. Enz, MD, and coresearchers in their retrospective case series. Their study evaluated differences in postop central macular thickness, central macular volume, corrected distance visual acuity, and the number of intravitreal anti-vascular endothelial growth factor (VEGF) injections. The study included 140 eyes (110 patients). No significant differences in postop central macular thickness, central macular volume, visual acuity, or postop anti-VEGF injections were found between the two groups over a mean follow-up of 619 days. With the 33 eyes that had an OCT measurement within 2 weeks postop, central macular volume was significantly lower in the femtosecond laser-treated eyes. The study appears in the Journal of Cataract & Refractive Surgery.

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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