Gathering R&R data is critically important. Knowing how many microns to consider margin of error when analyzing scans also ensures the accuracy of the device.
Golden, Colorado (PRWEB) March 01, 2016
ArcScan, Inc. announced today the start of a multicenter study to evaluate the intraoperator repeatability and interoperator reproducibility (R&R) of its Insight™ 100 for layered corneal thickness measurements (cornea, epithelium, and temporal epithelium) and anterior segment and lens capsule dimensions (sulcus diameter, anterior chamber depth, capsule thickness, and lens rise).
“We anticipate approving 3 to 5 study sites and enrolling 20 subjects each,” said lead investigator Amy Kelmenson, MD, of Colorado Ophthalmology Associates. “Gathering R&R data for ophthalmic imaging instruments is critically important. If we know what to consider as margin of error when analyzing anterior segment images, then we can be sure that every image we view, no matter who performed the scan, provides reliable data. Knowing how many microns to consider margin of error when analyzing scans also ensures the accuracy of the device. If there is a change over time on a particular patient, we can be confident that the change is real as opposed to differences related to the device or the operator,” Dr. Kelmenson said.
The study will involve each of two operators performing 5 corneal scans on one randomly chosen eye and 5 anterior segment/capsule scans on the fellow eye of 20 randomly chosen subjects from each site.
According to sub-investigator Jason M. Jacobs, MD, also of Colorado Ophthalmology Associates: “R&R data will demonstrate the accuracy, precision, and consistency of this exciting ultrasound technology. I look forward to discovering new ways in which these measurements will be able to improve patient care and outcomes.”
ArcScan’s technology promises to have major applications for corneal refractive and cataract surgery.
“The sky is the limit for a device like the Insight™ 100, which can very accurately assess corneal architecture and thickness, particularly for various pathologies,” said Elizabeth Yeu, MD, of Virginia Eye Consultants. “I’m looking forward to the ArcScan positively impacting our refractive surgery options, both in ectasia screening and for sizing with implantable collamer lens surgery. I believe this technology will be able to provide us with greater understanding of the anterior and posterior corneal surfaces, including total corneal power. The implications are many, and I’m eager to initiate studies to explore them.”
“The Insight™ 100 promises to be the missing link for catching refractive outliers in cataract surgery,” added William F. Wiley, MD, of the Cleveland Eye Clinic. “Using standard methods of IOL calculation, about 60% of patients are within a half diopter of the intended target after surgery. With advanced diagnostics, that number might go up to 70%, and when intraoperative aberrometry is applied, maybe close to 80%. But the ArcScan Insight™ 100 should help us bring more than 90% of our patients to within a half diopter of target, which is why I’m excited to be initiating ArcScan trials in the near future.”
ArcScan CEO Andy Levien emphasized his commitment to bringing an unmatched measurement perspective to ophthalmic diagnostic technology. “In order to improve refractive outcomes in cataract surgery, every step of the diagnostic and surgical process must be nailed down, and that begins with repeatability and reproducibility. R&R is an important and growing concern across the sciences—the Meta-Research Innovation Centre at Stanford, which opened in 2014, is entirely dedicated to these issues. As a cutting-edge ophthalmic technology company, we will always be investing in in this kind of research.”
To learn more about the ArcScan Insight™ 100 for anterior segment imaging or to schedule a demonstration, visit http://www.arcscan.com, email info(at)arcscan(dot)com, or call +1 877.363.7226 (+1 720.399.8500 from outside the US). Visit the ArcScan team at AECOS in Aspen, CO, February 28-March 2, 2016; and at ASCRS in New Orleans, LA, May 5-May 8, 2016.
About ArcScan: ArcScan develops smart visualization technology and is continually evolving ultrasound to provide ophthalmologists with new insights into the true anatomy of the anterior segment of the eye, including areas behind the iris. Arcscan’s mission is to enable better medicine in ophthalmology by driving improved outcomes in refractive, corneal, cataract, and glaucoma surgery.
phone: +1 877.363.SCAN (7226)
direct: +1 720.773.8552
mobile: +1 303.324.3887