Health Technology Assessment (HTA) of the Smaller-Incision New- Generation Implantable Miniature Telescope (SING IMT) for the management of patients with late-stage advanced age-related macular degeneration

Advanced age-related macular degeneration (AMD) is one of the leading causes of irreversible vision loss among people over 55 years of age in industrialized countries, affecting approximately 1 million individuals in Italy and having a major impact on quality of life as well as healthcare and social costs.

The report presents a multidimensional Health Technology Assessment (HTA) of the SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope), a miniaturized implantable telescope intended for patients with bilateral advanced AMD and severe visual impairment who are no longer responsive to pharmacological treatments.

The analysis, conducted according to the EUnetHTA Core Model® framework, examines the clinical, economic, organizational, ethical, and social aspects of the technology.

Clinical evidence demonstrates significant improvements in visual acuity, vision-related quality of life, and patients’ functional autonomy. The economic analysis also evaluates the cost-utility profile and the budget impact on the Italian National Health Service compared with best supportive care.

The findings highlight the value of SING IMT as an innovative therapeutic option for patients with substantial unmet clinical needs, contributing to the discussion on equitable access to innovation in ophthalmology.