Status:
COMPLETED
Tube Versus Trabeculectomy (TVT) Study
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Pfizer
Abbott Medical Optics
Conditions:
Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
NA
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 surg...
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 genera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00306852
Start Date
October 1 1999
End Date
May 1 2009
Last Update
November 25 2015
Active Locations (17)
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1
Scripps Clinic
La Jolla, California, United States, 92036
2
University of Southern California
Los Angeles, California, United States, 90033
3
University of California Davis
Sacramento, California, United States, 95817
4
University of Florida
Gainesville, Florida, United States, 32610