- Titel
- Effectiveness and safety of VISULAS ® green selective laser trabeculoplasty
- Untertitel
- a prospective, interventional multicenter clinical investigation
- Zitierfähige Url:
- https://nbn-resolving.org/urn:nbn:de:bsz:14-qucosa2-892089
- Quellenangabe
- International ophthalmology
Erscheinungsjahr: 2023
Jahrgang: 43
Seiten: 2215-2224
E-ISSN: 1573-2630 - Erstveröffentlichung
- 2022
- Abstract (EN)
- 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 naïve. 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.
- Andere Ausgabe
- Link zum Artikel der zuerst in der Zeitschrift „International ophthalmology” bei Springer erschienen ist.
DOI: 10.1007/s10792-022-02617-7 - Freie Schlagwörter (DE)
- Primäres Offenwinkelglaukom (POWG), Selektive Lasertrabekuloplastik (SLT), VISULAS® Grüner Laser, Senkung des Augeninnendrucks (IOD), Begleitende IOD-senkende Therapie, Unerwünschte Ereignisse
- Freie Schlagwörter (EN)
- Primary open-angle glaucoma (POAG), Selective laser trabeculoplasty (SLT), VISULAS® green laser, Intraocular pressure (IOP) reduction , Adjunctive IOP-lowering therapy, Adverse events
- Klassifikation (DDC)
- 610
- Verlag
- Springer Science + Business Media B.V, Dordrecht
- Förder- / Projektangaben
- Carl Zeiss Meditec AG
- Version / Begutachtungsstatus
- publizierte Version / Verlagsversion
- URN Qucosa
- urn:nbn:de:bsz:14-qucosa2-892089
- Veröffentlichungsdatum Qucosa
- 19.03.2024
- Dokumenttyp
- Artikel
- Sprache des Dokumentes
- Englisch
- Lizenz / Rechtehinweis
CC BY 4.0