Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up

Steven J Gedde, William J Feuer, Wei Shi, Kin Sheng Lim, Keith Barton, Saurabh Goyal, Iqbal I.K. Ahmed, Luis E Vazquez

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: 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 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: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results: The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20-5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29%) in the tube group and 48 patients (41%) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group (P = 0.03). Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.

Original languageEnglish (US)
JournalOphthalmology
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Trabeculectomy
Glaucoma
Intraocular Pressure
Reoperation
Glaucoma Drainage Implants
Mitomycin
Visual Fields
Visual Acuity
Randomized Controlled Trials

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. / Gedde, Steven J; Feuer, William J; Shi, Wei; Lim, Kin Sheng; Barton, Keith; Goyal, Saurabh; Ahmed, Iqbal I.K.; Vazquez, Luis E.

In: Ophthalmology, 01.01.2018.

Research output: Contribution to journalArticle

Gedde, Steven J ; Feuer, William J ; Shi, Wei ; Lim, Kin Sheng ; Barton, Keith ; Goyal, Saurabh ; Ahmed, Iqbal I.K. ; Vazquez, Luis E. / Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. In: Ophthalmology. 2018.
@article{76a5c31136d142f59a7b9f07adc41989,
title = "Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up",
abstract = "Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: 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 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: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20{\%} from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results: The cumulative probability of failure during the first year of follow-up was 17.3{\%} in the tube group and 7.9{\%} in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95{\%} confidence interval, 1.20-5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29{\%}) in the tube group and 48 patients (41{\%}) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1{\%}) in the tube group and 8 patients (7{\%}) in the trabeculectomy group (P = 0.03). Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.",
author = "Gedde, {Steven J} and Feuer, {William J} and Wei Shi and Lim, {Kin Sheng} and Keith Barton and Saurabh Goyal and Ahmed, {Iqbal I.K.} and Vazquez, {Luis E}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.ophtha.2018.02.003",
language = "English (US)",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up

AU - Gedde, Steven J

AU - Feuer, William J

AU - Shi, Wei

AU - Lim, Kin Sheng

AU - Barton, Keith

AU - Goyal, Saurabh

AU - Ahmed, Iqbal I.K.

AU - Vazquez, Luis E

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: 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 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: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results: The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20-5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29%) in the tube group and 48 patients (41%) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group (P = 0.03). Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.

AB - Purpose: To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: 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 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: Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results: The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the trabeculectomy group (P = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20-5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the trabeculectomy group at 1 year (P = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the trabeculectomy group (P < 0.001). Postoperative complications developed in 36 patients (29%) in the tube group and 48 patients (41%) in the trabeculectomy group (P = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the trabeculectomy group (P = 0.03). Conclusions: Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to trabeculectomy with MMC.

UR - http://www.scopus.com/inward/record.url?scp=85042173156&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85042173156&partnerID=8YFLogxK

U2 - 10.1016/j.ophtha.2018.02.003

DO - 10.1016/j.ophtha.2018.02.003

M3 - Article

AN - SCOPUS:85042173156

JO - Ophthalmology

JF - Ophthalmology

SN - 0161-6420

ER -