Status:
COMPLETED
Primary Tube Versus Trabeculectomy Study
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Abbott Medical Optics
Research to Prevent Blindness
Conditions:
Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
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 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00666237
Start Date
April 1 2008
End Date
April 1 2021
Last Update
October 19 2022
Active Locations (16)
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1
University of California Davis Medical Center
Sacramento, California, United States, 95817
2
University of Florida
Gainesville, Florida, United States, 32610
3
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
4
Johns Hopkins
Baltimore, Maryland, United States, 21290