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Trial record 1 of 1 for:    NCT00306852
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Tube Versus Trabeculectomy (TVT) Study

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ClinicalTrials.gov Identifier: NCT00306852
Recruitment Status : Completed
First Posted : March 24, 2006
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborators:
Pfizer
Abbott Medical Optics
Information provided by (Responsible Party):
Steven J. Gedde, University of Miami

Tracking Information
First Submitted Date  ICMJE March 23, 2006
First Posted Date  ICMJE March 24, 2006
Results First Submitted Date  ICMJE July 24, 2015
Results First Posted Date  ICMJE November 25, 2015
Last Update Posted Date November 25, 2015
Study Start Date  ICMJE October 1999
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • 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.
  • Rate of Complications [ Time Frame: 5 years ]
    Complications associated with both surgical procedures
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2006)
  • Intraocular pressure
  • Complication rates
  • Visual acuity
  • Visual field
  • Quality of life
  • Reoperations for glaucoma
  • Need for supplemental medical therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • Visual Acuity [ Time Frame: 5 years ]
    Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart
  • Reoperations for Glaucoma [ Time Frame: 5 years ]
    Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tube Versus Trabeculectomy (TVT) Study
Official Title  ICMJE Tube Versus Trabeculectomy (TVT) Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Active Comparator: Trabeculectomy
    Trabeculectomy with mitomycin C
    Intervention: Procedure: Trabeculectomy with mitomycin C
  • Active Comparator: Implant
    Baerveldt Implant
    Intervention: Procedure: Baerveldt implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2006)
212
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00306852
Other Study ID Numbers  ICMJE 19990167
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven J. Gedde, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Pfizer
  • Abbott Medical Optics
Investigators  ICMJE
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
PRS Account University of Miami
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP