Tube Versus Trabeculectomy (TVT) Study

Completed · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT00306852

Run by

University of Miami

People needed

212

Starts

1999-10-01

Expected to finish

2009-05-01

Last updated by the study team

2015-11-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Scripps Clinic — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Loyola University — Maywood, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• St. Louis University — St Louis, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Houston — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Moorfields Eye Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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