First-in-Human Implantation of an Add-On Dual Intraocular System Combining a Standard IOL and the SING-IMT™ Telescope: Optical Simulation, Preclinical Validation, and Clinical Feasibility

Purpose: To evaluate a dual-implant system combining a capsular-bag monofocal intraocular lens with a sulcus-implanted small-incision new-generation implantable miniature telescope (SING-IMT). Methods: Optical simulations quantified retinal spot size, modulation transfer function (MTF), and tolerance to misalignment. Preclinical porcine experiments evaluated surgical feasibility, anatomical stability, and early safety. First-in-human (FiH) implantation assessed surgical outcomes, anterior segment behaviour using ultrasound biomicroscopy and optical coherence tomography, functional vision, and safety over 6 months. Results: Optical modelling demonstrated that the dual-implant configuration maintained retinal image quality within the rehabilitative regime for advanced AMD, with root-mean-square retinal spot radii of 18.7 µm (0°) and 20.4 µm (2.5°), below the estimated retinal sampling limit (∼49 µm), consistent with an expected visual acuity improvement of approximately 2 Snellen lines. Decentration up to 0.5 mm was optically well tolerated, whereas tilt produced rapid mid-frequency contrast loss. In vivo porcine studies confirmed stable sulcus seating without disruption of the capsular-bag IOL or anterior segment structures. FiH implantation was completed without intraoperative complications. At 6 months, distance visual acuity improved from 20/200 to 20/125, near acuity from 56 to 15 Colenbrander units, and reading speed from non-assessable preoperatively to 20 words/min, with no device-related adverse events. Conclusion: This integrated evaluation supports the feasibility and short-term safety of sulcus-based SING-IMT implantation as a minimally invasive intraocular magnification strategy for selected pseudophakic patients with advanced AMD.