In the treatment of patients with open-angle glaucoma (OAG), gel stent is noninferior to trabeculectomy in terms of reducing intraocular pressure (IOP) by at least 20 percent, according to a study. Trabeculectomy helps reduce IOP to a greater extent, whereas gel stent leads to fewer adverse events (AEs).
The study included patients with OAG and IOP 15–44 mm Hg who were on topical IOP-lowering medication. They were randomly assigned to receive gel stent implantation or trabeculectomy.
The primary endpoint was surgical success, defined as the percentage of patients achieving ≥20-percent IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention (SSI) at month 12. Secondary endpoints included mean IOP and medication count, postoperative intervention rate, visual recovery, and patient-reported outcomes (PROs). Safety was also assessed.
At month 12, results for the primary endpoint showed that the gel stent was noninferior to trabeculectomy (62.1 percent vs 68.2 percent; between-treatment difference, −6.1 percent, 95 percent confidence interval, −22.9 to 10.8; p=0.487).
Mean IOP and medication count reductions from baseline were significant in both treatment groups (p<0.001). However, trabeculectomy was associated with a significantly greater decrease in IOP compared with gel stent (2.8 mm Hg; p=0.024).
Meanwhile, significantly fewer patients in the gel stent vs trabeculectomy group required in-office postoperative interventions (p=0.024 after excluding laser suture lysis), experienced faster visual recovery (p≤0.048), and had greater 6-month improvements in visual function problems (PROs; p≤0.022).
The most common AEs were reduced visual acuity at any time (gel stent 38.9 percent vs trabeculectomy 54.5 percent) and hypotony (IOP <6 mm Hg at any time; gel stent 23.2 percent vs trabeculectomy 50.0 percent).