Age-related macular degeneration (AMD) is a progressive retinal disorder affecting the macula, leading to central vision loss, primarily in older adults. Advanced AMD affects approximately 1% of individuals in developed countries and is divided into two forms: wet (neovascular) and dry (atrophic). While anti-VEGF therapies provide treatment for wet AMD, no therapies are currently available to restore vision in the 80–90% of patients with dry AMD, representing a significant unmet medical need.
To address this gap, a promising option available in CE Mark-referenced countries and under investigation in the United States is the Smaller-Incision New-Generation Implantable Miniature Telescope, or SING IMT®. This innovative intraocular device, designed for individuals with late-stage AMD, has shown positive intermediate-term results in improving both visual and safety outcomes, as recently reported by Samsara Vision.
Real-World Validation: Six-Month Study Outcomes
Published in the journal Heliyon, the new study found that SING IMT improved both distance and near vision — while exhibiting minimal effects on corneal endothelial cell density and a favorable safety profile.
Six months post-implantation (n=35), 97.1 percent of eyes achieved at least a one-line improvement in best-corrected distance visual acuity (BCDVA), while 68.6 percent and 51.4 percent of eyes achieved two- and three-line gains, respectively. The mean ± standard deviation (SD) change in BCDVA from baseline was −0.29 ± 0.142. Near visual acuity improved substantially, with 97.1% of patients able to read at near distance compared to 28.6% at baseline. Corrected near visual acuity improved by an average of three lines, underscoring the device’s impact on functional vision, which is strongly linked to vision-related quality of life. From a safety perspective, corneal edema persisting beyond 30 days was the most common complication, affecting 22.9% of patients. All cases were resolved with topical medications. Importantly, endothelial cell loss observed at six months was minimal, alleviating concerns about long-term safety. Compared to earlier versions of the device and standard cataract surgery, SING IMT demonstrated reduced endothelial cell loss, highlighting advancements in surgical design and safety outcomes. These findings support the efficacy and safety of the SING IMT as a therapeutic option for late-stage AMD.
The Study Design
This retrospective study included 35 patients aged 55 or older with bilateral late-stage AMD and cataract in the study eye. Participants had CDVA in the range of 20/80–20/800 without other retinal pathologies and good peripheral vision in the fellow eye. The study was conducted at two different sites. The SING IMT was implanted using standard cataract surgery techniques with a continuous manual circular anterior capsulorhexis. The foldable telescope devise, preloaded in a delivery system, was inserted through a 7.5–8 mm limbal incision at the 12 o’clock position and positioned in the capsular bag. The incision was sutured, and an in few cases iridectomy was performed.
Six weeks post-surgery, patients underwent a mandatory rehabilitation program consisting of approximately eight 90-minute sessions over six months. The program included exercises to improve visual skills such as reading, tracking, visual-motor integration, and mobility, aiming to optimize the collaboration between the implanted eye and the fellow eye.
The Science behind SING IMT
The Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) operates on well-established Galilean-like optical principles to address central vision loss in late-stage AMD. In a healthy eye, light diverging from a real object, such as a book, is focused by the cornea and crystalline lens onto the retina, forming an image. In late-stage AMD, central retinal damage prevents the formation of a clear image in the central field of vision. The SING IMT replaces the crystalline lens and utilizes its optical system, comprising advanced micro-optics that magnify the central field of view by approximately 2.7 times. This magnification effectively reduces the relative size of the central scotoma (blind spot), enabling the patient to perceive an enlarged image that “bypasses” the damaged central retina. As a result, individuals can regain the ability to perform visually demanding tasks, such as recognizing faces, reading, and watching television.
The device is implanted monocularly, preserving the peripheral vision of the untreated eye, which is essential for spatial orientation and balance. Post-implantation visual rehabilitation plays a critical role in optimizing outcomes, as it helps patients adapt to the magnified central image and integrate it with peripheral vision. To date, the SING IMT has been implanted in over 400 patients across 19 CE-referenced countries, with initial clinical results demonstrating its potential as a viable intervention for late-stage AMD.
The Conclusion
The SING IMT represents a significant advancement in addressing the unmet needs of patients with late-stage AMD, offering measurable improvements in both near and distance vision. By enabling patients to regain functional vision, such as reading, recognizing faces, and navigating their environment, the device demonstrates its potential to significantly enhance quality of life. These outcomes highlight the critical role of ongoing collaboration between surgeons, patients, and rehabilitation specialists in optimizing visual outcomes. Continued research and real-world validation will further establish the SING IMT as a transformative intervention for late-stage AMD.
Editor’s Note Dr. Faustino Vidal-Aroca is Vice President, Research and Development at Samsara Vision. With over 15 years of global experience in medical affairs, clinical operations, and scientific innovation, Dr. Vidal-Aroca brings a proven track record of leading impactful research and advancing patient care in ophthalmology.
