Samsara Vision implants miniature telescope in patient in China
According to the company, its implantable miniature telescope is a Galilean intraocular telescope designed to improve visual acuity and quality of life for patients with late-stage AMD.
(Image Credit: AdobeStock/Vadim)
Samsata Vision recently announced it has completed the first SING IMT (smaller-incision new-generation implantable miniature telescope) procedure in China.
The first procedure was performed by Li Xiaorong, MD, PhD, member of the Chinese Ophthalmological Society, specialist committee of the Chinese Ocular Fundus Diseases Society, and Dean of the Tianjin Medical University Eye Hospital and School of Optometry & Eye Institute, in early July at the First Affiliated Hospital of Hainan Medical University Lecheng Hospital. He is monitoring the recovery and vision rehabilitation of his patient.
According to a news release, Samsara Vision is partnering with Lansheng Medical, a company with extensive experience introducing ophthalmic products to the China market, which is leading the registration, clinical trial requirements, acquisition of surgeons and training, as well as sales and marketing efforts in Hong Kong, China and Macau, with support from Samsara Vision and experienced surgeons to provide training and counsel.1
“The surgery went well as the device is designed for ease of central insertion and we will monitor our patient’s visual rehabilitation as they learn to use their new vision,” Li said in the news release. “Many older adults in China live with central blindness caused by late-stage, age-related macular degeneration and it impacts their quality of life. I look forward to offering this procedure to future patients as we advance through clinical trials and anticipate regulatory approval in the future.”
Thomas Ruggia, president and CEO of Samsara Vision, noted the company is developing a global network of providers, researchers, health systems, and advocates who are introducing our novel technology to people living with non-preventable blindness caused by late-stage AMD.
“Our goal is for the SING IMT to be the standard of care for people who advance to late-stage AMD and we’re motivated by hearing the stories of patients resuming the activities they love,” he said in the news release. “We congratulate Prof. Li and thank our partners at Lensheng Medical for their commitment to advancing our presence in China.”
Currently, the SING IMT is approved for use in patients without previous cataract surgery and 55 years and older in CE Referenced countries and is under investigation in the United States.
Procedures across the European Union
According to the news release, nearly 100 surgeons in 17 countries have implanted the SING IMT in more than 350 patients, with more than 63 percent performing multiple procedures, signaling technology adoption.
Most recently, Petr Kolář, PhD, the head of the Eye Clinic at Slovak Medical University, and Nora Majtánová, PhD, deputy head of the Eye Clinic at Slovak Medical University in Bratislava, Slovakia performed over the course of a few days the first 6 surgeries in that country, which made national headlines with Radio and Television of Slovakia (Rozhlas a televize Slovenska - RTV), the nationwide public broadcasting media organization and other media covering the procedures, and with Zuzana Dolinková, Minister of Health of the Slovak Republic, in attendance.
Jason Herod, vice president of Commercial, International Markets, Samsara Vision, pointed out the device can impact patients’ quality of life.
“Low vision often leads to social isolation, which is why it’s so inspiring that hundreds of patients across Europe are seeing better and reengaging with their families after getting the SING IMT and participating in required low vision therapy,” Herod said in the news release. “Our post-marketing studies show that these patients are meeting vision milestones that improve their ability to read, write, and discern what is in their straight-ahead central vision. Our patients are seeing the faces of loved ones for the first time in years.”
According to a retrospective study, physician confidence grows from their experience with the SING IMT and from post-marketing studies demonstrating that the majority of patients with late-stage AMD monocularly implanted with the SING IMT had improved functional vision after participating in a rehabilitation program focused on real-world tasks such as reading, writing, visual motor integration and mobility.2 This is a key development because reading performance is one of the best predictors of patient-reported visual ability and vision-related quality of life.
The researchers in that study pointed out that the device demonstrated promise in addressing visual acuity and functional outcomes in patients with late-stage AMD.
“The results demonstrate significant improvements in reading skills and fixation stability, with most patients achieving benefits within 4–5 rehabilitation sessions,” they wrote. “The collaborative effort of a multidisciplinary team and strict patient selection played crucial roles in achieving successful outcomes. While the study has limitations, such as a small sample size and single-center design, the findings highlight the potential of SING IMT and rehabilitation training in improving functional outcomes in patients with late-stage AMD. Further research is needed to validate these findings in larger and more diverse populations.”
The miniature telescope is a Galilean intraocular telescope designed to improve visual acuity and quality of life for patients with late-stage AMD. The design improves upon an FDA 1st-generation miniature telescope device implanted in more than 600 patients in that it has a new foldable haptic design that enables enhanced stability and centration during the out-patient procedure.
The company also noted there is a new Tsert SI delivery system, which is designed to ensure consistent, predictable delivery of the device. Together, this reduces the length of the surgical procedure, the incision size, and the number of sutures, which hastens recovery. The images are seen in “straight-ahead” vision, and they are enlarged 2.7x onto a healthy retina surrounding the macular in the back of the eye. The device reduces the impact of the AMD blind spot in central vision and it enables patients to see things that previously were unrecognizable.
While there are traditional external optical or video magnifiers that can help to enlarge vision at a particular distance or for a single activity, there is nothing like the SING IMT that allows people to use their new vision for seeing things at all distances, stationary and in locomotion, and for performing multiple activities in ways similar to natural vision.
Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the top cause of blindness in people age 65 years and older.1 There are as many as 11 million Americans impacted by some form of AMD, and that number is expected to rise by 2050.4
In the European Union, 67 million people are affected by AMD and this number is expected to grow by 15% until 2050.5 In China, the prevalence of AMD among people who are more than 70 years old is 20.2 percent, and as the population ages, the incidence of AMD continues to grow.6
References:
Samsara Vision Announces First SING IMT® (Smaller-Incision New-Generation Implantable Miniature Telescope) Patient in China and Accelerating Global Rollout. Samsara Vision, Inc. Published July 22, 2024. Accessed July 24, 2024. https://www.samsaravision.com/press-releases/detail/71/samsara-vision-announces-first-sing-imt-smaller-incision
Sasso, P., Savastano, A., Vidal-Aroca, F. et al. Enhancing the Functional Performance of Patients with Late-Stage Age-Related Macular Degeneration Implanted with a Miniature Telescope using Rehabilitation Training. Ophthalmol Ther 13, 697–707 (2024). https://doi.org/10.1007/s40123-023-00871-1
Macular Degeneration. www.aoa.org. https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/macular-degeneration?sso=y
Age-Related Macular Degeneration: Facts & Figures. BrightFocus Foundation. Published April 10, 2018. https://www.brightfocus.org/macular/article/age-related-macular-facts-figures
Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysisBritish Journal of Ophthalmology 2020;104:1077-1084.
Chinese Vitreo-Retina Society of Chinese Medical Association; Fundus Disease Group of Chinese Ophthalmologist Association. [Evidence-based guidelines for diagnosis and treatment of age-related macular degeneration in China (2023)]. Zhonghua Yan Ke Za Zhi. 2023 May 11;59(5):347-366. Chinese. doi: 10.3760/cma.j.cn112142-20221222-00649. PMID: 37032564.
