The Implantable Miniature Telescope (IMT) from VisionCare for end-stage age-related macular degeneration (AMD) maintains best-corrected visual acuity (BCVA) improvements to two years, according to results published in the November edition of the American Journal of Ophthalmology.
VisionCare's Implantable Miniature Telescope (IMT) for end-stage age-related macular degeneration (AMD) maintains best-corrected visual acuity (BCVA) improvements to two years, according to results published in the November edition of the American Journal of Ophthalmology.
Henry L. Hudson of the Retina Centers, PC, Tucson, Arizona (US) and colleagues implanted the IMT in end-stage AMD patients with BCVA of 20/80 to 20/800 (n=188) in a multicentre, open-label, prospective Phase II/III trial, which was designed to assess safety and efficacy. Data from 92.6% of implanted eyes were available.
At 24 months, 59.5% of eyes (n=103) improved BCVA by ≥3 lines. In patients implanted with the 3X magnifying lens, mean BCVA improvement from baseline was 3.6 lines; in patients implanted with the 2.2X magnifying lens, this improvement was 2.8 lines. BCVA decreased by ≥3 lines in 0.6% of implanted eyes. At the 24-month follow-up visit, endothelial cell loss had increased by 2.4% to 27% from the 12-month follow-up, although endothelial cell dysfunction (ECD) was stable. The most frequently observed adverse event was inflammatory deposits.
The investigators concluded that the benefits of the IMT were maintained at two years, with - in comparison with the BCVA improvements - only minor surgical risks. The device is currently CE marked and is awaiting FDA approval.