Three-Month Efficacy/Safety Data of SING IMT for AMD Published

The first and largest single-surgeon case series to describe the short-term (3 months) safety and efficacy outcomes of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) in patients with severe to profound bilateral central vision impairment due to advanced AMD was published in the Journal of Clinical Medicine.

This retrospective, single-center study conducted at the Department of Ophthalmology, University of Naples Federico II, Italy (February 2022 - June 2022) included 24 patients (54.2% female) with a mean age at enrollment of 77.0 ± 6.16 years (median: 76.0 years, range: 69.0–91.0 years). 

By months 1 and 3, the study eye had significantly higher best-corrected distance and near visual acuity (CDVA) than the fellow eye (P<0.0001 for both). The average change in study eye CDVA from baseline was +7.3 ± 5.1 letters (P<0.0001) at 1 month, increasing to +14.9 ± 7.1 letters (P<0.0001) at 3 months. In comparison, the fellow eye experienced no appreciable CDVA change from baseline, with −0.1 ± 1.1 letters and 0.0 ± 0.8 letters at 1 and 3 months, respectively.

From baseline, ECD loss in the study eyes was 10.4 ± 13.3% at 3 months, however, ECD was comparable between the study and fellow eyes at all time points. 

It was observed that improvements to the SING IMT device resulted in considerably lower ECD loss than its predecessor, while achieving similar visual acuity outcomes at 3 months post-op compared to those achieved with the first-generation IMT device at 12 months post-op (as reported in earlier studies).

Postoperative corneal edema (swelling) was the most common side effect and was resolved medically with topical treatment within 2 months in most cases.

The patients will continue to be monitored up to 12 months post-implantation. 

Available in Europe since 2020, an advancement of the SING IMT implant compared to the predecessor IMT (implantable telescope, FDA approved in 2010) is the potential for increased safety of the device, ease of implantation compared to its predecessor, and quicker healing for patients, according to Samsara Vision. SING IMT comes in a preloaded device for insertion that allows the surgeon to generate a smaller corneal wound (6.5–7.5 mm vs. 10–12 mm), which could make the procedure less invasive, safer, and improve postoperative recovery.

Study link: https://www.mdpi.com/2077-0383/12/2/518