Samsara Vision has announced positive intermediate-term results from a study evaluating the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) in patients with late-stage age-related macular degeneration (AMD). The study, which followed patients for six months post-surgery, demonstrated significant improvements in both distance and near vision, coupled with a manageable safety profile.
The research, published in Heliyon, involved 35 patients aged 55 years or older with late-stage AMD who were treated at the University Federico II in Naples and the Policlinico Gemelli Hospital in Rome, Italy. The primary outcome measures included best-corrected distance visual acuity (BCDVA) and distance-corrected near visual acuity (DCNVA), intraocular pressure (IOP), anterior chamber depth (ACD), corneal endothelial cell density (ECD), and adverse events.
Visual Acuity Improvements
The study reported notable gains in BCDVA, with 97.1% of operated eyes experiencing at least a one-line improvement. Furthermore, 68.6% and 51.4% of eyes showed at least two and three-line improvements, respectively. The ability to read at a near distance also saw a marked increase, from 28.6% at baseline to 97.1% at six months. Corrected near visual acuity improved by approximately three lines after surgery.
Safety and Corneal Health
Safety assessments revealed no clinically meaningful changes in intraocular pressure or anterior chamber depth. The mean change in corneal endothelial cell density at six months was -280.7 cells/mm², representing an -11.4% change. Most adverse events, including corneal edema (22.9%), resolved with topical medications by the six-month mark. Some device-related events, such as iris damage and pigment deposits, were observed, but the overall safety profile was deemed acceptable.
Rehabilitation Program
All patients underwent a structured rehabilitation program starting six weeks post-surgery. This program included eight 90-minute sessions over six months, focusing on enhancing visual skills, reading, writing, visual motor integration, and mobility. The rehabilitation was crucial for optimizing visual outcomes following SING IMT implantation.
Expert Commentary
"This six-month review highlights the potential of SING IMT to restore meaningful vision to individuals blinded by AMD, while preserving long-term corneal health with its innovative design," said co-author Mario Damiano Toro, a professor at the University of Naples Federico II.
Co-author Alfonso Savastano, a professor at La Libera Università Mediterranea, added, "We will continue monitoring these patients to ensure their improved vision translates into a better quality of life and enhanced daily functioning."
Market and Regulatory Status
The SING IMT is approved for use in patients aged 55 years and older without previous cataract surgery in CE-referenced countries. To date, the device has been implanted in over 400 patients across 19 CE-referenced countries. The SING IMT is currently under investigation in the United States.
About AMD
Age-related macular degeneration (AMD) is a leading cause of permanent vision loss in individuals aged 50 and older. Approximately 11 million people in the US are affected by AMD, with nearly 2 million experiencing advanced forms. This number is projected to double by 2050. While treatments exist to slow the progression of AMD, the SING IMT offers a potential solution for improving vision in late-stage cases.
