Medical device firm SightGlass Vision has started enrolling children aged between six and nine years at its multicenter trial designed to assess novel eyeglasses to control nearsightedness.
Image: SightGlass Vision has commenced patient enrollment in multicenter trial of novel eyeglasses. Photo: courtesy of Joshua Newton / Unsplash.
SightGlass is currently enrolling patients in the Cypress study at clinical sites in the US and Canada.
The company intends to recruit up to 255 patients across in the multicenter, double-blinded and randomized controlled clinical trial.
SightGlass is planning to complete the trial enrollment by the end of the first quarter this year and reveal initial results in 2020 followed by additional data with longer-term follow up.
The firm has designed the Cypress study to assess the safety and efficacy of the novel lenses compared against standard spectacles to decrease the rate of progression of myopia in children aged six-to-nine years old.
According to the company, glasses and contact lenses presently marketed in the US only correct myopia and cannot prevent it from getting worse.
The progression of myopia (change in axial length and change in spherical equivalent refraction) over 36 months is the primary outcome measure of the study.
Trial participants can selected from a variety of eyeglass frames, and provides flexibility to use one of three types of lenses instead of their normal glasses.
SightGlass offers eyeglasses to the participants at free of cost and need to financially compensate for time and travel expenses, said the company. Children involved in the study will secure comprehensive eye care at no cost while they in the study.
Katie Gilbert-Spear, principal investigator in Pensacola of Florida, said: “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.”
Based in Palo Alto of California, SightGlass Vision is a clinical-stage medtech startup firm engaged in the development of advanced spectacle lenses to reduce the progression of myopia in children.