SightGlass Vision Multicenter Trial to Study Novel Eyeglasses to Control Nearsightedness for FDA Approval
PALO ALTO, Calif., /PRNewswire/ -- SightGlass Vision, Inc., a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, today announced its ground-breaking, pivotal clinical trial to control nearsightedness in children, CYPRESS, is currently enrolling patients in the U.S. and Canada. The CYPRESS study is evaluating the safety and efficacy of the company's novel lenses compared to standard spectacles to reduce the rate of progression of myopia in children aged six-to-nine years old. Glasses and contact lenses currently available in the U.S. only correct myopia, but do not help prevent it from getting worse.
"Although some people view myopia as an ordinary, often unavoidable condition, it has been well established that it often progresses rapidly during childhood. This results in the need for stronger prescription glasses and increases the risk of potentially blinding conditions such as glaucoma and retinal detachment in adulthood," Katie Gilbert-Spear, OD, MPH, Principal Investigator in Pensacola, Florida. "We are pleased to be part of the CYPRESS program to study SightGlass's novel lenses which could help revolutionize myopia care."
Myopia has seen a dramatic increase in prevalence over the past several decades. In the early 1970's, only 25 percent of Americans were nearsighted. By the early 2000's, that number had jumped to more than 40 percent. It is estimated that almost half of the entire world's population, or five billion people, will be nearsighted by 2050. This increase is thought to relate to lifestyle changes, including less time outdoors and more eye-straining or work-related activities such as reading and screen time.
The CYPRESS trial is a multicenter, double-blinded, randomized controlled clinical trial that plans to enroll 255 patients across 14 clinical sites in the U.S. and Canada. The primary outcome measure is progression of myopia (change in axial length and change in spherical equivalent refraction) over 36 months. Trial participants will be able to choose from a variety of eyeglass frames and will be asked to use one of three types of lenses instead of their normal glasses. The eyeglasses used in the study are provided at no cost and participants will be financially compensated for time and travel expenses. Children participating will also receive comprehensive eye care at no cost during the time they are in the study.
Interested parents can go to www.kidsvision.info to learn more about the study and search for a nearby clinical site.
SightGlass expects to complete trial enrollment by the end of Q1 2019 and report initial results from the CYPRESS study in 2020, followed by additional data with longer-term follow up.
About SightGlass Vision, Inc.
SOURCE SightGlass Vision, Inc.