Safety and Efficacy Data
In clinical trials, the Intraocular Telescope procedure improved visual acuity and quality of life in the majority of subjects with Late-Stage Age-Related Macular Degeneration (AMD).
Late-Stage Age-Related macular degeneration (AMD) is the most advanced form of AMD, the leading cause of legal blindness in the U.S. (1) Currently there is no known treatment that can cure for Late-Stage AMD (bilateral geographic atrophy or disciform scars on both eyes).
Central vision loss resulting from Late-Stage AMD cannot be corrected with glasses, contact lenses, anti-VEGF injections, or surgically implanted intraocular lenses (IOLs). (1) Individuals with this level of bilateral vision loss may use external appliances such as hand-held magnifying eyeglasses or a head-mounted telescope in order to enlarge images onto the retina. There are other assistive devices that increase illumination to enhance visual acuity. However, these devices have inherent limitations known to ophthalmologists and other eye care specialists (e.g., limited field of view, disruption of image stability; vestibular-ocular reflex issues with head motion; poor compliance and utilization; and limited utility in dynamic ‘on-the-go’ or social situations).
1. Forooghian F, Agrón E, Clemons TE, Ferris FL 3rd, Chew EY; Age-Related Eye Disease Study Research Group. Visual acuity outcomes after cataract surgery in patients with age-related macular degeneration: age-related eye disease study report no. 27. Ophthalmology. 2009;116:2093-100.
2. Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE. IMT002 Study Group. Implantable Telescope for End-Stage Age-Related Macular Degeneration. Long-Term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008;146:664-673.