A Prospective, Multicenter Clinical Investigation To Evaluate Safety And Effectiveness Of Visulas Green Selective Laser Trabeculoplasty (Slt)

To evaluate the safety and effectiveness of Selective Laser Trabeculoplasty (SLT) with the VISULAS green (Carl Zeiss Meditec, Germany) laser for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG).

The study was conducted using VISULAS green with SLT Option in 5 research centres in Germany: Universitätsklinikum Carl Gustav Carus (Dresden), Universitätsklinikum Schleswig-Holstein (Kiel), Augentagesklinik Rheine (Rheine), Augenarztpraxis am Dreiecksplatz (Kiel) and Internationale Innovative Ophthalmochirurgie GbR (Düsseldorf).

This is a prospective, multi-center pre-market clinical investigation including patients with POAG, aged ≥ 22, who did not meet individual IOP targets, had an IOP ≥17mmHg and angle Shaffer of 3 or 4. Exclusion criteria included conditions that prevented contact lens stability or laser delivery, planned surgery within 3 months, pregnancy and lactation. Approximately, 100 lesions were applied in each session to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up period. Efficacy outcomes were postoperative absolute and relative IOP changes at 1 and 3 months. Safety outcomes included 1-hour and 1-day postoperative IOP measurements and rate of intraoperative and postoperative adverse effects.

33 eyes of 33 subjects were included. Mean baseline IOP (mmHg) was 21.0±2.69 and it 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% reduction in IOP at 3 months [95% CI = 30.8%; 66.5%]. The mean relative reduction in IOP was -16.4% and -16.3% at 1 and 3 months, respectively and was statistically significant for both follow-up time points (p<0.0001). Potentially device- or procedure-related adverse events included 3 postoperative IOP spikes and 5 eye pain or discomfort, all resolved without sequalae. All reported adverse events were of mild to moderate intensity and no serious adverse events were registered.

The investigational device VISULAS green demonstrated clinically significant efficacy in terms of lowering the IOP in eyes with POAG. Its results are comparable to other SLT devices and the difference from baseline in terms of reduction in IOP was statistically significant.