Tube Versus Trabeculectomy (TVT) Study

October 22, 2015 updated by: Steven J. Gedde, University of Miami
The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glaucoma surgery is performed when further intraocular pressure (IOP) reduction is needed despite the use of maximum tolerated medical therapy and appropriate laser treatment. Trabeculectomy is generally used as the initial incisional surgical procedure in managing glaucoma. However, eyes in which trabeculectomy has failed are at greater risk of failure with subsequent filtering surgery. Wound modulation with antifibrotic agents, like mitomycin C (MMC) and 5-fluorouracil (5-FU), has been shown to increase the success rate of trabeculectomy in eyes that have undergone previous ocular surgery. Although antifibrotic agents have increased the likelihood of IOP control following filtering surgery, they have also increased the risk of complications. The prevalence of bleb leaks, bleb-related infections, and bleb dysesthesia associated with a perilimbal filtering bleb suggests the need to consider alternatives. Tube shunts (or glaucoma drainage implants) offer an alternative to trabeculectomy in the surgical management of glaucoma, and these devices have been growing in popularity in recent years.

Practice patterns vary in the surgical management of glaucoma in eyes with previous ocular surgery. In 1996, Chen and colleagues conducted an anonymous survey of members of the American Glaucoma Society (AGS) and Japanese Glaucoma Society (JGS) to evaluate use of antifibrotic agents and tube shunts. The survey presented ten clinical situations requiring glaucoma surgical intervention. The majority of respondents (59-83%) preferred trabeculectomy with MMC for the clinical scenarios involving prior ocular surgery, although many of those surveyed elected to use a tube shunt, trabeculectomy with 5-FU, or trabeculectomy without an antifibrotic agent. In 2002, Joshi and associates re-administered the same survey to members of the AGS. Respondents still favored trabeculectomy with MMC, but the percentage usage of tube shunts had significantly increased. The greatest practice pattern shift was observed in patients with previous cataract and glaucoma surgery. In particular, selection of tube shunts as the preferred surgical approach increased from 7% to 22% in eyes with prior trabeculectomy, and increased from 8% to 22% in eyes with prior extracapsular or intracapsular cataract extraction.

The lack of consensus among glaucoma surgeons regarding the use of tube shunts or trabeculectomy with an antifibrotic agent in eyes that have had prior cataract or glaucoma surgery likely relates to the fact that available clinical data has not shown one surgical procedure to be superior to the other. Similar surgical results have been reported with both glaucoma procedures in eyes with aphakia/pseudophakia and failed filters when studied separately. Success rates have ranged from 50% to 88% for tube shunts, and 48% to 86% for filtering surgery with an antifibrotic agent in case series studying aphakic/pseudophakic eyes. Success rates have ranged from 44% to 88% for tube shunts, and 61% to 100% for 5-FU and MMC trabeculectomy in eyes with failed filters. Comparable rates of severe complications have also been reported with tube shunt surgery and trabeculectomy with an adjunctive antifibrotic agent.

The Tube Versus Trabeculectomy (TVT) Study was designed to prospectively compare the safety and efficacy of nonvalved tube shunt surgery and trabeculectomy with MMC. Patients with uncontrolled glaucoma who had prior cataract extraction with intraocular lens implantation and/or failed filtering surgery were enrolled in this multicenter clinical trial and randomized to placement of a 350 Baerveldt glaucoma implant (Advanced Medical Optics, Irvine, CA) or trabeculectomy with MMC (0.4 mg/ml for 4 minutes). The goal of this investigator initiated trial is to provide information that will assist in surgical decision-making in similar patient groups.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Moorfields Eye Hospital
  • United States
    • California
      • La Jolla, California, United States, 92036
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University Of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Houston
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 85 years
  • Intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
  • Previous trabeculectomy, cataract extraction with intraocular lens implantation, or both

Exclusion Criteria:

  • Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
  • Pregnant or nursing women
  • No light perception vision
  • Active iris neovascularization or active proliferative retinopathy
  • Iridocorneal endothelial syndrome
  • Epithelial or fibrous downgrowth
  • Aphakia
  • Vitreous in the anterior chamber for which a vitrectomy is anticipated
  • Chronic or recurrent uveitis
  • Severe posterior blepharitis
  • Unwilling to discontinue contact lens use after surgery
  • Previous cyclodestructive procedure, scleral buckling procedure, or presence of silicone oil
  • Conjunctival scarring precluding a trabeculectomy superiorly
  • Need for glaucoma surgery combined with other ocular procedures (eg cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trabeculectomy
Trabeculectomy with mitomycin C
Procedure: Trabeculectomy with mitomycin C
Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant
Active Comparator: Implant
Baerveldt Implant
Procedure: Baerveldt implant
Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure
Time Frame: Baseline to 5 years
The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.
Baseline to 5 years
Rate of Complications
Time Frame: 5 years
Complications associated with both surgical procedures
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 5 years
Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart
5 years
Reoperations for Glaucoma
Time Frame: 5 years
Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.
5 years
Need for Supplemental Medical Therapy
Time Frame: 5 years
The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years
5 years
Failure Rate
Time Frame: 5 years
Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Pfizer
Abbott Medical Optics

Investigators

  • Study Chair: Steven J Gedde, M.D., Bascom Palmer Eye Institute
  • Study Chair: Dale K Heuer, M.D., Medical College of Wisconsin
  • Study Chair: Richard K Parrish, M.D., Bascom Palmer Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19990167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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