The publication details the two-year safety profile of the device and found rates of cornea endothelial cell loss, while higher than conventional small-incision anterior segment eye surgery, were consistent with anterior segment procedures employing more similar incision sizes required for telescope implantation.
"The published data show improved visual acuity in end-stage AMD patients
that was maintained over two years -- a three-line improvement that we have
previously shown makes a real impact on our patients' independence and quality
of life," said
"The data presented in
"We hope these published results will lead to a new treatment option for
patients with end-stage AMD," commented
End-Stage AMD occurs when the macula in each eye is irreversibly
degenerated and no longer provides detailed central vision required for common
everyday activities such as reading, recognizing people and facial
expressions, or watching television. End-Stage AMD is characterized by central
scotomas, or blind spots, in both eyes that cause images in the central visual
field to be unrecognizable or not visible at all. AMD is the leading cause of
irreversible blindness in
Highlights from the
-- 60% of telescope-implanted study eyes gained 3 lines (15 letters) or more of visual acuity (VA) at 2 years after implantation versus 10% of fellow eye controls (p<0.0001)
-- Study eyes receiving the 3X model telescope prosthesis showed an average VA improvement of 3.6 lines at 2 years compared to 0.5 lines in fellow eye controls (p<0.0001)
-- Median VA improvement was over 3 lines better in telescope-implanted eyes versus corresponding fellow eyes that underwent cataract surgery and intraocular lens implantation (p<0.0002)
-- Loss of 3 lines (15 letters) or more of VA occurred in 0.6% of telescope-implanted eyes versus 7.5% of fellow eye controls (p=0.0013)
-- Corneal endothelial cell loss was 27% two years after surgery, versus 20% through 3 months and 25% through 12 months
"The long-term results described in this publication reflect years of
technical and clinical development in collaboration with the IMT002 Study
Group investigators," said
The results are published in the
About the Telescope Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr.
The prospective, multicenter IMT002 Phase II/III trial was designed to evaluate the safety and efficacy of VisionCare's investigational medical device in individuals with moderate to profound bilateral central vision impairment associated with End-Stage AMD. A Premarket Approval (PMA) application and subsequent PMA amendments have been submitted to the U.S. Food and Drug Administration and are currently under regulatory review.
About Macular Degeneration
Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like reading, recognizing faces, and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as end-stage AMD (visual impairment due to untreatable advanced AMD). Patients affected in both eyes often experience a loss of independence, social interaction, and have difficulty with activities of daily living requiring detailed vision. Approximately half of the individuals living with advanced AMD are affected in both eyes.
VisionCare Ophthalmic Technologies, Inc., headquartered in
SOURCE VisionCare Ophthalmic Technologies, Inc.