Clinical trial NCT00306852: Tube Versus Trabeculectomy (TVT) Study
Official title: Tube Versus Trabeculectomy (TVT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Trabeculectomy
Tube shunt surgery
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Abbott Medical Optics
First posted: 2006-03-24
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Intraocular Pressure
timeFrame: Baseline to 5 years
measure: Rate of Complications
timeFrame: 5 years
Secondary outcomes:
measure: Visual Acuity
timeFrame: 5 years
measure: Reoperations for Glaucoma
timeFrame: 5 years
measure: Need for Supplemental Medical Therapy
timeFrame: 5 years
measure: Failure Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Steven J Gedde, M.D.
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin
name: Dale K Heuer, M.D.
role: STUDY_CHAIR
affiliation: Bascom Palmer Eye Institute
name: Richard K Parrish, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.