Primary Tube Versus Trabeculectomy Study

University of Miami

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Mitomycin C

Procedure: Tube shunt surgery

Procedure: Trabeculectomy

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00666237

20071037

EY014801 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

242 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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