Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up

Abstract

Purpose: To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: Unmasked multicenter randomized clinical trial. Participants: Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group.Methods: Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).Main Outcome Measures: The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications.Results: The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P ¼ 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9e2.2). Mean AE standard deviation IOP was 14.0AE4.2 mmHg in the tube group and 12.1AE4.8 mmHg in the trabeculectomy group at 3 years (P ¼ 0.008), and the number of glaucoma medications was 2.1AE1.4 in the tube group and 1.2AE1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P ¼ 0.11).Conclusions: There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures. Ophthalmology 2020;127:333-345 ª 2019 by the American Academy of Ophthalmology Supplemental material available at www.aaojournal.org.Johnson Vision, Santa Ana, CA) or trabeculectomy with MMC. The goal of this investigator-initiated study was to offer information that will assist in surgical decision making in similar patient groups. The methodology and outcomes during the first postoperative year are described in previous publications. 6,7 The primary outcome measure in the PTVT Study was the cumulative rate of surgical failure at 1 year. The present report provides 3-year follow-up data on enrolled patients. MethodsThe study was approved by the institutional review board at each clinical center before recruitment was initiated (see Appendix,

Comparing the efficacy of trabeculectomy and XEN gel microstent implantation for the treatment of primary open-angle glaucoma: a retrospective monocentric comparative cohort study

“…Hence, a risk for causing inadvertent damage to lens and iris with following accelerated opacification of the crystalline lens exists during implantation of the XEN microstent. Additionally, TETs are presumed to produce more pronounced IOP reduction 21 – 23 . Therefore, TET was performed in eyes requiring more aggressive IOP reduction, such as only eyes, eyes with a clear crystalline lens and eyes in need for a complete stop of all topical IOP-lowering medication after surgery.…”

<p>The Baerveldt Glaucoma Drainage Device: Efficacy, Safety, and Place in Therapy</p>

“…However, the increased IOP reduction at 5 years follow-up ( Figure 3) is likely caused by currently unavailable 5 year data from the Primary Tube Versus Trabeculectomy study. 5,6 According to Gedde et al, 26 the Primary Tube Versus Trabeculectomy study has a lower baseline IOP resulting in lower IOP reduction, causing a lower mean IOP reduction on other follow-up points in the meta-analysis ( Figure 2). The reduction in IOP-lowering medication fluctuates during the first month, but remains relatively constant with a mean reduction of 1.81 IOP-lowering medication from baseline at 5 years of follow-up.…”

Exact matching of trabectome-mediated ab interno trabeculectomy to conventional trabeculectomy with mitomycin C followed for 2 years

“…TRAB lowers IOP by allowing aqueous humor to bypass the conventional outflow system and drain into a bleb, a subtenon reservoir, from which aqueous is removed by lymphatics, absorpti on, and transconjunctival diffusion [39]. It is well established [40,41] that trabeculectomies can lower IOP and reduce medications profoundly, but have a higher risk of complications and often need additional interventions. In contrast to that, AIT removes a primary substrate of outflow resistance, the trabecular meshwork [29].…”