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

Primary Tube Versus Trabeculectomy Study Group

Research output: Contribution to journalArticle

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-mm2 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 = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9–2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 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 = 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.

Original languageEnglish (US)
JournalOphthalmology
DOIs
StateAccepted/In press - Jan 1 2019

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Trabeculectomy
Glaucoma
Intraocular Pressure
Reoperation
Outcome Assessment (Health Care)
Glaucoma Drainage Implants
Mitomycin
Visual Acuity
Randomized Controlled Trials
Confidence Intervals
Light

ASJC Scopus subject areas

  • Ophthalmology

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Treatment Outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study after 3 Years of Follow-up. / Primary Tube Versus Trabeculectomy Study Group.

In: Ophthalmology, 01.01.2019.

Research output: Contribution to journalArticle

@article{659fdec8c2434ff4b04ec3899d8bb7ab,
title = "Treatment Outcomes in the Primary Tube Versus Trabeculectomy (PTVT) 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-mm2 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 = 0.17; hazard ratio, 1.39; 95{\%} confidence interval, 0.9–2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 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 = 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.",
author = "{Primary Tube Versus Trabeculectomy Study Group} and Gedde, {Steven J.} and Feuer, {William J.} and Lim, {Kin Sheng} and Keith Barton and Saurabh Goyal and Ahmed, {Iqbal I.} and Brandt, {James D.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.ophtha.2019.10.002",
language = "English (US)",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Inc.",

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T1 - Treatment Outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study after 3 Years of Follow-up

AU - Primary Tube Versus Trabeculectomy Study Group

AU - Gedde, Steven J.

AU - Feuer, William J.

AU - Lim, Kin Sheng

AU - Barton, Keith

AU - Goyal, Saurabh

AU - Ahmed, Iqbal I.

AU - Brandt, James D.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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-mm2 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 = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9–2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 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 = 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.

AB - 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-mm2 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 = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9–2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 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 = 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.

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