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

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.

Capsule Dynamics, Implantation, and Explantation of the Smaller Incision, New-Generation Implantable Miniature Telescope: a Miyake–Apple Study

“…However, sulcus implantation was not mentioned. 5 We found that the zonular stress observed during the studied rescue maneuvers was tolerable and no further, more challenging complications, such as posterior capsule rupture, arose from sulcus implantation.…”

“…It is implanted through a 6.5- to 7.5-mm incision; a 5.5-mm capsulorhexis is sufficient, less sutures are needed to close the incisional wound, and the duration of the implantation procedure is greatly reduced. 5 Nevertheless, implanting the device still poses a challenge to surgeons because of its axial length of 4.4 mm, haptic diameter of 10.8 mm, its greater weight of 63 mg in the aqueous humor, the unusual unfolding action of the silicone haptics, and the delivery where the lens optic has to be aligned orthogonally to the direction of implantation (Figure 1).…”

Small-Incision new generation implantable miniature telescope surgical technique and patient outcomes

“…The new SING IMT shows promising characteristics, however careful study of the procedure is necessary to ensure the best outcomes. Short-term safety and efficacy results with the new SING IMT are encouraging, 6 as well as in vitro recent assessment. First of all, the cornea incision should not be performed on clear cornea in order to avoid high surgical induced astigmatism (SIA) which has been reported more than 10 Diopters in the IMT.…”

“…The new SING IMT shows promising characteristics, however careful study of the procedure is necessary to ensure the best outcomes. Short-term safety and efficacy results with the new SING IMT are encouraging, 6 as well as in vitro recent assessment. 7…”

Intraoperative Iridectomy in Femto-Laser Assisted Smaller-Incision New Generation Implantable Miniature Telescope

“…We aimed at investigating safety outcomes, as well. In literature the most common reported AE were inflammatory deposits on the device [ 12 , 13 , 14 , 15 , 18 ]. Differently, we did not find any inflammatory or pigmented deposits on the lens in our study population.…”