Purpose: To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: Multicenter randomized clinical trial. Participants: Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery. Methods: Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). Main Outcome Measures: The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications. Conclusions: Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.
Bibliographical noteFunding Information:
Supported by Abbott Medical Optics, Santa Ana, California; the National Eye Institute, Bethesda, Maryland (grant no.: EY014801); and Research to Prevent Blindness, Inc., New York, New York. The sponsors had no role in the design or conduct of this research.
© 2017 American Academy of Ophthalmology