EyeWorld Weekly Update, April 6, 2018

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April 6, 2018
Volume 24 , Number 12

Patient enrollment completed for Phase 2 study of conjunctivochalasis treatment

Sixty-two patients have been enrolled in a multicenter Phase 2 trial in Israel of LO2A (Wize Pharma, Hod HaSharon, Israel), designed to treat patients with moderate to severe conjunctivochalasis. LO2A is approved in Israel for dry eye syndrome. The randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of LO2A compared with placebo in patients with conjunctivochalasis. Patients are randomly assigned 1:1 to an LO2A group or a placebo group and will be treated with topical eye drops for 3 months. The primary endpoint will be the change from baseline in lissamine green conjunctival staining score after 3 months. Although the trial is underway in Israel, it is designed according to U.S. standards, and it may support a clinical development path for LO2A in the U.S., according to a Wize press release.

Phase 2b study of OPT-302 for wet AMD begins in Europe, Israel

The first patients in Europe and Israel have been dosed for an ongoing Phase 2b trial of OPT-302 (Opthea Limited, Melbourne, Australia) for wet age-related macular degeneration (AMD), according to a company press release. OPT-302 is a soluble form of vascular endothelial growth factor receptor (VEGF) 3 that blocks the activity of VEGF-C and VEGF-D. The randomized, controlled clinical trial for OPT-302, used in combination with ranibizumab (Lucentis, Genentech, South San Francisco), began dosing at U.S. clinical sites in December. The international Phase 2b study is enrolling patients from more than 50 clinical sites in the U.S., about six trial sites in Israel, and more than 50 trial sites in European countries. The trial will include approximately 351 patients with wet AMD who are treatment-naïve to assess whether the addition of OPT-302 to ranibizumab therapy over 6-month dosing improves visual acuity and anatomical parameters of wet AMD. Primary analysis of study data is expected in early 2020, the company reported.

Obstructive sleep apnea 10 to 20 times more prevalent among keratoconus patients

Obstructive sleep apnea (OSA) was 10 to 20 times more common among patients with keratoconus compared with the rate in the general population, according to a study led by Emilio Pedrotti, MD. In the study's 50 consecutively enrolled patients, OSA was diagnosed with an overnight home sleep apnea test. Researchers considered an apnea-hypopnea index threshold of five or more sleep-related obstructive breathing events per hour as suggestive of OSA. To grade keratoconus severity, slit lamp biomicroscopy, corneal topography, and pachymetry were used. The mean patient age was 43.6 years; the mean body mass index (BMI) was 29.7 kg/m2, and the mean neck circumference was 40 cm. The prevalence of OSA was 38%; patients with OSA tended to be older and had a higher BMI and neck circumference as well as a higher cylinder diopter compared with those who did not have OSA. There was no significant association found between OSA severity and ocular parameters and keratoconus grade. The study appears in Cornea.

RESEARCH BRIEFS

  • In a retrospective analysis of clinical and molecular data, a substantial percentage of keratoconjunctivitis was not associated with a detectable adenovirus, reported Cecelia Lee, MD, and coresearchers. Their research aimed to determine host and pathogen factors that are predictive of outcomes in a large clinical cohort with keratoconjunctivitis. The study used data from a randomized, controlled, masked trial of auricloscene for keratoconjunctivitis. There were 500 total participants from around the world, including the U.S. All participants had a clinical diagnosis of keratoconjunctivitis and positive rapid test results for adenovirus. Among the participants, 78% showed evidence of adenovirus by polymerase chain reaction. Adenovirus D species was most common (63% of total cases); however, four species and 21 different types of adenovirus were detected. Adenovirus D was associated with more severe signs and symptoms and a slower decline in viral load. Participants from outside the U.S. had poorer clinical outcomes. The research is published in Ophthalmology.
  • A scleral-glued IOL is a good option for eyes with pseudoexfoliation and poor zonular integrity or absent capsular support, reported Ashwinee Ragam and coresearchers in their retrospective chart review and outcome analysis of 28 eyes. Indications for scleral-glued IOL fixation included late endocapsular IOL dislocation (75%), exchange for an iris-fixated IOL due to complications (14%), subluxed crystalline lens (7%), and aphakia after complicated surgery (4%). At the time of scleral-glued surgery, 54% of eyes had preexisting glaucoma. Ocular hypertension was the most common postop complication (29% of eyes). The corrected distance visual acuity was equivalent to or improved from preop measurements in 89% of eyes. Special attention should be given to IOP control after surgery as it can be less predictable in eyes with pseudoexfoliation, the authors wrote. The study appears in the Journal of GlaucomaJ.
  • A new posterior corneal astigmatism algorithm decreased the error in the prediction of residual refractive astigmatism in eyes with toric IOLs, reported Carmen Canovas, PhD, and coauthors. They used the exact vergence formula of the Tecnis toric calculator (Johnson & Johnson Vision, Santa Ana, California) to predict refractive astigmatism from preop biometry, surgeon-estimated surgically induced astigmatism, and implanted IOL power. The error in predicted refractive astigmatism was calculated as the vector difference between the prediction and the actual refraction for each calculation method. Among the 274 eyes, the posterior corneal astigmatism algorithm significantly decreased the centroid error in predicted refractive astigmatism (P<.001). Patients with anterior corneal against-the-rule, with-the-rule, and oblique astigmatism had improvements with the algorithm. The algorithm also lowered the median absolute error in all groups. The study is published in the Journal of Cataract & Refractive Surgery.
  • Use of a video game in patients with amblyopia did not improve visual outcomes more than a placebo video game, reported Tina Gao, BOptom, and coresearchers. Their randomized controlled trial included 115 participants between 7 and 55 years old who played either a falling blocks video game at home on a tablet for 1 hour a day for 6 weeks or a placebo video game. The main outcome measure was change in amblyopic eye visual acuity at 6 weeks. Secondary outcomes included compliance, stereoacuity, and interocular suppression. The mean visual acuity of the amblyopic eye improved to 0.06 logMAR from baseline in the active group (n=56) and 0.07 logMAR in the placebo group (n=59). The mean treatment difference between the groups was -0.02 logMAR after adjustments for baseline visual acuity and age group. At 6 weeks, 64% of participants in the active group achieved a fellow eye contrast greater than 0.9 in the binocular video game. There were three reports of transit asthenopia. The study is published in JAMA Ophthalmology.
PRODUCT NEWS
  • Diamatrix (The Woodlands, Texas) launched the X1 Ready-Loaded Iris Speculum. The disposable iris speculum is fully loaded with an XpandNT Iris Speculum, a thin biocompatible Nitinol device that is flexible and maintains its shape through all surgical manipulations, according to a company press release. The X1 can be used in the management of complicated cataracts from IFIS or dilation limiting factors.

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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