OphthalmologyDecember 201757 citations

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

Gedde Steven J, Chen Philip P, Heuer Dale K, Singh Kuldev, Wright Martha M, Feuer William J, Schiffman Joyce C, Shi Wei

View on PubMed DOI: 10.1016/j.ophtha.2017.10.037

AI Summary

This study compares tube shunts and trabeculectomy with mitomycin C for uncontrolled glaucoma, aiming to determine which primary surgery is more effective, providing crucial data for clinical practice.

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-mm 2 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.

MeSH Terms

Alkylating AgentsAntihypertensive AgentsGlaucoma Drainage ImplantsGlaucoma, Open-AngleHumansIntraocular PressureMitomycinOphthalmoscopyPostoperative ComplicationsProsthesis ImplantationReoperationTonometry, OcularTrabeculectomyTreatment OutcomeVisual AcuityVisual Field TestsVisual Fields

Shields Classification

Ch. 27Management of the Glaucoma Patient

Ch. 39Principles of Incisional Surgery

Ch. 40Filtering Surgery

Key Concepts3

The Primary Tube Versus Trabeculectomy (PTVT) Study is a multicenter randomized clinical trial comparing tube shunt surgery (350-mm 2 Baerveldt glaucoma implant) and trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes) in patients with medically uncontrolled glaucoma and no prior incisional ocular surgery.

MethodologyRCTMulticenter Randomized Clinical Trialn=Patients enrolled at 16 clinical centersCh40Ch41

The primary outcome measure for the Primary Tube Versus Trabeculectomy (PTVT) Study 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.

MethodologyRCTMulticenter Randomized Clinical Trialn=Patients enrolled at 16 clinical centersCh28Ch40Ch41

Secondary outcome measures for the Primary Tube Versus Trabeculectomy (PTVT) Study include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications.