NCT00306852

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1999

Longer than P75 for not_applicable

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

November 25, 2015

Completed
Last Updated

November 25, 2015

Status Verified

October 1, 2015

Enrollment Period

9.5 years

First QC Date

March 23, 2006

Results QC Date

July 24, 2015

Last Update Submit

October 22, 2015

Conditions

Glaucoma

Keywords

GlaucomaTrabeculectomyTube shunt surgery

Outcome Measures

Primary Outcomes (2)

  • Change in Intraocular Pressure

    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

    Complications associated with both surgical procedures

    5 years

Secondary Outcomes (4)

  • Visual Acuity

    5 years

  • Reoperations for Glaucoma

    5 years

  • Need for Supplemental Medical Therapy

    5 years

  • Failure Rate

    5 years

Study Arms (2)

Trabeculectomy

ACTIVE COMPARATOR

Trabeculectomy with mitomycin C

Procedure: Trabeculectomy with mitomycin C

Implant

ACTIVE COMPARATOR

Baerveldt Implant

Procedure: Baerveldt implant

Interventions

Baerveldt implantPROCEDURE

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)

Implant
Trabeculectomy with mitomycin CPROCEDURE

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

Trabeculectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Scripps Clinic

La Jolla, California, 92036, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Moorfields Eye Hospital

London, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 33657420DERIVED

  • 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.

    PMID: 24531027DERIVED

  • 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.

    PMID: 22245458DERIVED

  • 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.

    PMID: 22244522DERIVED

  • 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.

    PMID: 19674729DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Glaucoma Drainage ImplantsTrabeculectomyMitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesFiltering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, OperativeMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Steven Gedde
Organization
University of Miami
sgedde@med.miami.edu
305-326-6435

Study Officials

  • 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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 24, 2006

Study Start

October 1, 1999

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

November 25, 2015

Results First Posted

November 25, 2015

Record last verified: 2015-10

Locations

US(16)GB(1)