PMCF Samsara SING IMT System, model NG SI IMT 3X
Research type
Research Study
Full title
A prospective, multicenter post-marketing clinical investigation of the SING IMT TM System, model NG SI IMT 3X in patients with central vision impairment associated with end-stage age-related macular degeneration
IRAS ID
328542
Contact name
Giuliana Silvestri
Contact email
Sponsor organisation
Samsara Vision Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Macular degeneration is the deterioration of the cells in the center of the retina (macula). The main effect of age-related macular degeneration (AMD) is to reduce the affected person's ability to perform daily activities that require clear vision, such as reading.
Advanced AMD is estimated to affect 1% of 55-year-olds and the likelihood of its occurrence increases with age, reaching 15% of those over 80 years of age.
The only treatments currently available for end-stage AMD are low vision aids, such as special glasses, and hand-held or head-mounted telescopes, which help to see better by magnifying objects. These instruments are cumbersome, uncomfortable and unattractive.
The objective of this study is to demonstrate the safety and effectiveness of the implantable miniature telescope (SING IMT system, model NG SI IMT 3X) in improving clarity of vision in patients with central vision impairment related to end-stage AMD.
Samsara Vision (sponsor of the research study) developed a miniature telescope prosthesis called the SING IMT System, model NG SI IMT 3X that is implanted in the eye and functions as a magnification system to improve near and far vision in suitable patients. This device is CE-marked.
The device contains two small lenses in the central visual field and helps the patient to recognize and identify objects that he or she would not otherwise be able to see.
Eligible patients will be males and females, 55 years of age or older, who have central vision impairment associated with end-stage AMD.
The study will take place in 7 sites across Europe and UK.
Eligible subjects who agree to participate will undergo surgery and implantation of the miniature telescope, in only one eye and will be followed up for 13 months after surgery with at least 7 postoperative visits and 6 to 10 vision training sessions.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0137
Date of REC Opinion
20 Jul 2023
REC opinion
Further Information Favourable Opinion