Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months - 12/07/23
, VANESSA VERA b, DAVINDER S. GROVER c, STEVEN D. VOLD d, FRANK COTTER e, SAHAR BEDROOD f, g, GAGAN SAWHNEY h, SCOTT D. PIETTE i, SUSAN SIMONYI j, XUEMIN GU k, MINI BALARAM l, MARK J. GALLARDO mRésumé |
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.
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| Supplemental Material available at AJO.com. |
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| Meeting Presentations: This work was partially presented at the 2022 Annual American Glaucoma Society (AGS) Meeting (March 3-6, 2022, Nashville, TN) and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting (April 22-26, 2022, Washington, DC). |
Vol 252
P. 306-325 - août 2023 Retour au numéro
Article précédent
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