NCT00306852
Tube Versus Trabeculectomy (TVT) Study
NA
COMPLETED
NCT00306852
INTERVENTIONAL
Tube Versus Trabeculectomy (TVT) Study
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.
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
Glaucoma
- TREATMENT
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- Type: PROCEDURE
- Name: Baerveldt implant
- Description: Patients will be randomized to receive a 350 mm\^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)
- Arm Group Labels: Implant
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- Type: PROCEDURE
- Name: Trabeculectomy with mitomycin C
- Description: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm\^2 Baerveldt glaucoma implant
- Arm Group Labels: Trabeculectomy
- University of Miami