MedDataX Logo

Tube Versus Trabeculectomy (TVT) Study

NCT ID: NCT00306852

Last Updated: 2015-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trabeculectomy

Trabeculectomy with mitomycin C

Group Type ACTIVE_COMPARATOR

Trabeculectomy with mitomycin C

Intervention Type PROCEDURE

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

Implant

Baerveldt Implant

Group Type ACTIVE_COMPARATOR

Baerveldt implant

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Abbott Medical Optics

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven J. Gedde

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven J Gedde, M.D.

Role: STUDY_CHAIR

Bascom Palmer Eye Institute

Dale K Heuer, M.D.

Role: STUDY_CHAIR

Medical College of Wisconsin

Richard K Parrish, M.D.

Role: STUDY_CHAIR

Bascom Palmer Eye Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Scripps Clinic

La Jolla, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

University of California Davis

Sacramento, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Loyola University

Maywood, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Texas Houston

Houston, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Vanner EA, Sun CQ, McSoley MJ, Persad PJ, Feuer WJ, Lum F, Kelly SP, Parrish RK, Chang TC, Gedde SJ. Tube Versus Trabeculectomy IRISⓇ Registry 1-Year Composite Outcome Analysis with Comparisons to the Randomized Controlled Trial. Am J Ophthalmol. 2021 Jul;227:87-99. doi: 10.1016/j.ajo.2021.02.023. Epub 2021 Feb 28.

Reference Type DERIVED
PMID: 33657420 (View on PubMed)

Saheb H, Gedde SJ, Schiffman JC, Feuer WJ; Tube Versus Trabeculectomy Study Group. Outcomes of glaucoma reoperations in the Tube Versus Trabeculectomy (TVT) Study. Am J Ophthalmol. 2014 Jun;157(6):1179-1189.e2. doi: 10.1016/j.ajo.2014.02.027. Epub 2014 Feb 14.

Reference Type DERIVED
PMID: 24531027 (View on PubMed)

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.

Reference Type DERIVED
PMID: 22245458 (View on PubMed)

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC; Tube Versus Trabeculectomy Study Group. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012 May;153(5):804-814.e1. doi: 10.1016/j.ajo.2011.10.024. Epub 2012 Jan 14.

Reference Type DERIVED
PMID: 22244522 (View on PubMed)

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube Versus Trabeculectomy Study Group. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009 Nov;148(5):670-84. doi: 10.1016/j.ajo.2009.06.018. Epub 2009 Aug 11.

Reference Type DERIVED
PMID: 19674729 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19990167

Identifier Type: -

Identifier Source: org_study_id