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

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

SUBMITTER: Gedde SJ 

PROVIDER: S-EPMC9289720 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature