Peer-reviewed journal article

Effectiveness and safety of ZEISS VISULAS green selective laser trabeculoplasty

A prospective, interventional multicenter clinical investigation

10 March 2022 · 25 min read

Author Karin R. Pillunat Department of Ophthalmology, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Germany

Author Florian T. A. Kretz Precise Vision Augenärzte, Augentagesklinik Rheine, Germany

Author Stefan Koinzer Augenarztpraxis Am Dreiecksplatz/Kiel, Germany

Author Christoph Ehlken Department of Ophthalmology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany

Author Lutz E. Pillunat Department of Ophthalmology, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Germany

Author Karsten Klabe Internationale Innovative Ophthalmochirurgie GbR, Düsseldorf, Germany

Original title:
Effectiveness and safety of VISULAS^® green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation

Source:
Pillunat, K.R., Kretz, F.T.A., Koinzer, S. et al. Effectiveness and safety of VISULAS^®green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation. Int Ophthalmol (2022). https://doi.org/10.1007/s10792-022-02617-7

Abstract

Purpose

To evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS^®green laser in patients with primary open-angle glaucoma (POAG).

Methods

This prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS^® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events.

Results

Thirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naive. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by − 3.53 ± 3.34 [95% CI − 4.61; − 2.45] and − 3.59 ± 3.41 [95% CI − 4.64; − 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was − 16.4% and − 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae.

Conclusions

SLT performed with the VISULAS^® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies.

_{Link to Creative Commons licence: https://creativecommons.org/licenses/by/4.0/

The study was initiated and funded by Carl Zeiss Meditec AG, Jena, Germany. The authors have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support.}