A propective multicenter clinical trial to evaluate the afety and effectivene of the implantable miniature telecope

Purpoe To evaluate the afety and preliminary efficacy of a novel viual prothetic device, the Implantable Miniature Telecope, IMT (by Dr Iaac Liphitz) (IMT), in a phae I trial in patient with ignificant bilateral central viion impairment from late-tage age-related macular degeneration (AMD). The IMT i deigned to reduce the relative ize of the cotoma by rendering enlarged (threefold) central viual field image over the central and peripheral retina. Deign Propective, multicenter, open-label clinical trial. Method In thi propective, multicenter phae I trial, 14 patient aged 60 or older with bilateral geographic atrophy or diciform car AMD, cataract, and bet-corrected viual acuity (BCVA) between 20/80 and 20/400 had an IMT implanted in one eye. Ditance and near BCVA, endothelial cell denity, and quality of life, meaured a activitie of daily life (ADL), were evaluated preoperatively and potoperatively. Reult At 12 month, 10 (77%) of 13 patient gained 2 more line of either ditance or near BCVA, and eight (62%) of 13 patient gained 3 or more line in either ditance or near BCVA. Mean endothelial cell denity decreaed by 13%. All advere event reolved without equelae. ADL core improved in the majority of patient. Concluion The reult of thi phae I trial upport further evaluation of the IMT in a larger tudy population with late-tage AMD. A phae II/III trial i in progre.