Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™).

Abstract

The smaller-incision new-generation implantable miniature telescope (SING IMT™) is the second generation of the IMT™, a telescope prosthesis that is indicated for monocular implantation in patients with stable vision impairment caused by bilateral central scotomas associated with end-stage Age-related macular degeneration (AMD). This non-comparative retrospective study is the first and largest single-surgeon case series to evaluate the short-term (3 months) safety and efficacy of the device in patients with disciform scars or geographic atrophy at baseline. The main outcome measures included best-corrected distance and near visual acuity (CDVA and CDNVA, respectively), endothelial cell density (ECD) loss, and the incidence of complications. At postoperative month 3 in the study eyes, mean CDVA and CDNVA improved by +14.9 ± 7.1 letters and +7.7 ± 3.2 Jaeger levels, respectively. Importantly, 70.83% of patients gained ≥ 2 lines, 58.33% ≥ 3 lines, and 25.00% ≥ 4 lines of CDVA. From baseline, ECD loss in the study eyes was 10.4 ± 13.3% at 3 months, however, ECD was comparable between the study and fellow eyes at all time points. The most common complication was corneal edema. In all, these short-term outcomes suggest that the SING IMT™ delivers lower ECD loss than the first-generation IMT ™, but similar visual outcomes and safety.