Primary Tube Versus Trabeculectomy Study

Completed · Phase 4

Conditions studied: Glaucoma

In brief

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.

Key facts

Study ID

NCT00666237

Run by

University of Miami

People needed

242

Starts

2008-04-01

Expected to finish

2021-04-01

Last updated by the study team

2022-10-19

Who can join

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

You may qualify if…

• Age 18-85 years
• Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
• No previous incisional ocular surgery

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 ingrowth
• Chronic or recurrent uveitis
• Steroid-induced glaucoma
• Severe posterior blepharitis
• Unwilling to discontinue contact lens use after surgery
• Previous cyclodestructive procedure
• Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy
• Functionally significant cataract
• Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Johns Hopkins — Baltimore, Maryland, United States
• St. Louis University — St Louis, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Glaucoma Associates of Texas — Dallas, Texas, United States
• University of Texas, Houston — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Toronto — Toronto, Canada
• Moorfields Eye Hospital — London, United Kingdom
• St. Thomas' Hospital — London, United Kingdom
• Queen Mary's Sidcup Hospital — Sidcup, United Kingdom

Full record on ClinicalTrials.gov

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