Tube Versus Trabeculectomy (TVT) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by University of Miami.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Pfizer
Abbott Medical Optics
Research to Prevent Blindness
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00306852
First received: March 23, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Glaucoma
Procedure: Baerveldt glaucoma implant
Procedure: Trabeculectomy with mitomycin C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tube Versus Trabeculectomy (TVT) Study

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Intraocular pressure
  • Complication rates
  • Visual acuity
  • Visual field
  • Quality of life
  • Reoperations for glaucoma
  • Need for supplemental medical therapy

Estimated Enrollment: 212
Study Start Date: October 1999
Estimated Study Completion Date: April 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306852

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

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00306852     History of Changes
Other Study ID Numbers: 1999-0167, NEI grant EY014801
Study First Received: March 23, 2006
Last Updated: March 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Glaucoma
Trabeculectomy
Tube shunt surgery

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 22, 2014