Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 May;125(5):774-781.
doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.

The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C

Steven J Gedde  1 , Philip P Chen  2 , Dale K Heuer  3 , Kuldev Singh  4 , Martha M Wright  5 , William J Feuer  6 , Joyce C Schiffman  6 , Wei Shi  6 ; Primary Tube Versus Trabeculectomy Study Group
Affiliations
Randomized Controlled Trial

The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C

Steven J Gedde et al. Ophthalmology. 2018 May.

Abstract

Purpose: To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study.

Design: Multicenter randomized clinical trial.

Participants: Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.

Methods: Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes).

Main outcome measures: The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) 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. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications.

Conclusions: Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.

PubMed Disclaimer

References

    1. Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of various glaucoma surgeries and procedures in Medicare beneficiaries from 1994 to 2012. Ophthalmology. 2015;122:1615–1624. - PubMed
    1. Chen PP, Yamamoto T, Sawada A, et al. Use of antifibrosis agents and glaucoma drainage devices in the American and Japanese Glaucoma Societies. J Glaucoma. 2007;16:14–19. - PubMed
    1. Joshi AB, Parrish RK, Feuer WF. 2002 survey of the American Glaucoma Society: Practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005;14:172–174. - PubMed
    1. Desai MA, Gedde SJ, Feuer WJ, et al. Practice preferences for glaucoma surgery: A survey of the American Glaucoma Society in 2008. Ophthalmic Surg Lasers Imaging. 2011;42:202–208. - PubMed
    1. Vinod K, Gedde SJ, Feuer WJ, et al. Practice preferences for glaucoma surgery: A survey of the American Glaucoma Society. J Glaucoma. 2017;26:687–693. - PMC - PubMed

Publication types

MeSH terms