Fewer AEs with microshunt implantation than trabeculectomy in POAG patients
In a 1-year sub-analysis of a multicenter study comparing the standalone microshunt to trabeculectomy in patients with uncontrolled primary open-angle glaucoma (POAG), the device/procedure-related adverse events (AE) primarily occurred by 1 month in both groups, with significantly fewer AEs for the microshunt implantation group. Lower hypotony rates were seen in the microshunt versus trabeculectomy group, according to a poster presented at AA0 2020 Virtual.
Researchers evaluated the safety outcomes of a randomized multicenter study of the MicroShunt (MS; InnFocus Inc./Santen), a controlled micro-incisional ab-externo glaucoma filtration surgery device vs trabeculectomy in POAG patients at 29 sites. Under the study, eyes with uncontrolled IOP (15-40 mm Hg) on maximum tolerated therapy underwent MS or trabeculectomy surgery. In a 1-year sub-analysis, in 395 MS and 131 trabeculectomy eyes, postoperative device/procedure-related AE rates were 80.3% in the MS group vs 86.3% in the trabeculectomy group. Most AEs occurred by 1 month (60.8% MS, 78.6% trabeculectomy). The most common AEs were increased IOP requiring treatment (46.3% vs 49.6%), hypotony (IOP <6 mm Hg; 26.8% vs 45.0%) and bleeding/hyphema (mostly mild-moderate; 17.7% vs 14.5%). Incidence of AEs of best-corrected visual acuity (BCVA) loss was 5.6% vs 6.1%, and visual field worsening was 8.4% vs 4.6%. Needling rates were 19.0% MS vs 8.4% trabeculectomy (3.6% vs 2.3% had ≥2 needlings). In addition, bleb revision rates were 5.8% MS vs 6.9% trabeculectomy. The incidence of glaucoma reoperations was low following both treatments.
Moster MR, et al. Safety outcomes of microshunt implantation vs. trabeculectomy in patients with POAG. Presented at: AAO 2020 Virtual. [Session: PO0193].