Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months.

PURPOSE: To compare effectiveness and safety of the gel stent to trabeculectomy in open-angle glaucoma (OAG). DESIGN: Prospective, randomized, multicenter, noninferiority study. METHODS: Patients with OAG and intraocular pressure (IOP) 15 to 44 mm Hg on topical IOP-lowering medication were randomized 2:1 to gel stent implantation or trabeculectomy. Primary end point (surgical success): percentage of patients at month 12 achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention (SSI) in a noninferiority test with 24% margins. Secondary end points (month 12) included mean IOP and medication count, postoperative intervention rate, visual recovery, and patient-reported outcomes (PROs). Safety end points included adverse events (AEs). RESULTS: At month 12, the gel stent was statistically noninferior to trabeculectomy (between-treatment difference [Δ], -6.1%; 95% CI, -22.9%, 10.8%); 62.1% and 68.2% achieved the primary end point, respectively (P=.487); mean IOP and medication count reductions from baseline were significant (P<.001); and the IOP change-related Δ (2.8 mm Hg) favored trabeculectomy (P=.024). The gel stent resulted in fewer eyes requiring in-office postoperative interventions (P=.024 after excluding laser suture lysis), faster visual recovery (P≤.048), and greater 6-month improvements in visual function problems (ie, PROs; P≤.022). The most common AEs were reduced visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony (IOP <6 mm Hg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%). CONCLUSIONS: At month 12, the gel stent was statistically noninferior to trabeculectomy, per the percentage of patients achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Trabeculectomy achieved a statistically lower mean IOP, numerically lower failure rate, and numerically lower need for supplemental medications. The gel stent resulted in fewer postoperative interventions, better visual recovery, and fewer AEs.

Pathological optic-disc cupping.

PURPOSE OF REVIEW: Pathological optic-disc cupping is most often caused by glaucoma, but may be seen in many less-common neuro-ophthalmic conditions. The goal of this article is to examine a host of entities causing optic-disc cupping, present key differentiating characteristics and pathophysiologies, and outline diagnostic approaches. RECENT FINDINGS: Multiple entities not associated with elevated intraocular pressure or glaucomatous optic-nerve disease may result in pathologic optic-nerve excavation. Even with the photography and imaging of today, it is still difficult for the clinician to accurately diagnose other causes of optic-disc cupping. Up to 20% of patients may be misdiagnosed and treated for glaucoma due to misinterpretation of the optic-disc cupping. Newer forms of imaging including optical coherence tomography may assist the clinician in decision making. A scrutinizing history, close observation of disc appearance, and the vasculature will aid in the diagnosis of glaucoma or other entity of optic-disc cupping. SUMMARY: Optic-disc cupping is a consequence of myriad disorders. Knowledge of the anatomy and vasculature of the disc is quintessential to the understanding of how, why, when, and what type of optic-disc cupping occurs in various conditions. Cupping can be seen with neurological processes, including benign tumors, which are treatable. Patient history, visual fields assessment, and funduscopic findings are the key to unlocking the diagnosis of glaucomatous versus nonglaucomatous optic-disc cupping. As clinicians, we must remain vigilant and receptive to the findings of potentially ominous forms of nonglaucomatous optic-disc cupping.