Primary Tube Versus Trabeculectomy Study

Summary

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.

Conditions

• Glaucoma

Interventions

PROCEDURE

Tube shunt surgery

The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.

PROCEDURE

Trabeculectomy

The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.

DRUG

Mitomycin C

A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes

Sponsors & Collaborators

• Abbott Medical Optics

  collaborator INDUSTRY

• Research to Prevent Blindness

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• University of Miami

  lead OTHER

Principal Investigators

• Steven J Gedde, MD · Bascom Palmer Eye Institute

• Dale K Heuer, MD · Medical College of Wisconsin

• Richard K Parrish, MD · Bascom Palmer Eye Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-01

Primary Completion

2021-04-01

Completion

2021-04-01

FDA Drug

Yes

Countries

• United States
• Canada
• United Kingdom

Study Locations