Primary Tube Versus Trabeculectomy Study

Primary Tube Versus Trabeculectomy Study

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.

Inclusion Criteria:

• 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 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 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