Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™)

Mario Damiano Toro; Faustino Vidal-Aroca; Marina Montemagni; Claudio Xompero; Gaetano Fioretto; Ciro Costagliola

doi:10.3390/jcm12020518

Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™)

J Clin Med. 2023 Jan 8;12(2):518. doi: 10.3390/jcm12020518.

Authors

Mario Damiano Toro^{1

2}, Faustino Vidal-Aroca³, Marina Montemagni⁴, Claudio Xompero⁴, Gaetano Fioretto⁴, Ciro Costagliola⁴

Affiliations

¹ Eye Clinic, Department of Public Health, University of Naples Federico II, 80131 Naples, Italy.
² Chair and Department of General and Pediatric Ophthalmology, Medical University of Lublin, 20079 Lublin, Poland.
³ Department of Scientific Affairs, Medevise Consulting, 16 avenue de l'Europe, 67300 Schiltigheim, France.
⁴ Eye Clinic, Department of Neurosciences, Reproductive and Dentistry Sciences, University of Naples Federico II, 80131 Naples, Italy.

Abstract

The smaller-incision new-generation implantable miniature telescope (SING IMT™) is the second generation of the IMT™, a telescope prosthesis that is indicated for monocular implantation in patients with stable vision impairment caused by bilateral central scotomas associated with end-stage Age-related macular degeneration (AMD). This non-comparative retrospective study is the first and largest single-surgeon case series to evaluate the short-term (3 months) safety and efficacy of the device in patients with disciform scars or geographic atrophy at baseline. The main outcome measures included best-corrected distance and near visual acuity (CDVA and CDNVA, respectively), endothelial cell density (ECD) loss, and the incidence of complications. At postoperative month 3 in the study eyes, mean CDVA and CDNVA improved by +14.9 ± 7.1 letters and +7.7 ± 3.2 Jaeger levels, respectively. Importantly, 70.83% of patients gained ≥ 2 lines, 58.33% ≥ 3 lines, and 25.00% ≥ 4 lines of CDVA. 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. The most common complication was corneal edema. In all, these short-term outcomes suggest that the SING IMT™ delivers lower ECD loss than the first-generation IMT ™, but similar visual outcomes and safety.

Keywords: end-stage age-related macular degeneration; geographic atrophy; low vision; small-incision new-generation implantable miniature telescope; visual impairment; visual prosthesis.

Grants and funding

This research was technically supported in part by the Department of Ophthalmology, University of Naples Federico II, Naples, Italy. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.