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,
This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.
All tonometers underestimate IOP, with increasing inaccuracy at higher pressures. The Perkins applanation tonometer was the most reliable for measuring IOP in the range of 0 to 50 mm Hg in New Zealand White rabbits.
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