Samsara Vision announced the completion of the first U.S. surgeries of its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.-based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. David RP Almeida, MD, MBA, PhD, from Erie Retinal Surgery (PA), and Marc H. Levy, MD, from the Sarasota Retina Institute (FL), performed the first procedures using the SING IMT™ in late June.
The CONCERTO trial will recruit 100 adults aged 65 and older living with stable (non-active neovascularization), bilateral central scotomas (blind spots) due to late-stage AMD and fovea-involving geographic atrophy or disciform scar to receive a SING IMT™ in one eye. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.