The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C
| Autor: | Steven J, Gedde, Philip P, Chen, Dale K, Heuer, Kuldev, Singh, Martha M, Wright, William J, Feuer, Joyce C, Schiffman, Wei, Shi |
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| Rok vydání: | 2017 |
| Předmět: |
Reoperation
Alkylating Agents Mitomycin Visual Acuity Trabeculectomy Article Ophthalmoscopy Prosthesis Implantation Tonometry Ocular Postoperative Complications Treatment Outcome Humans Visual Field Tests Visual Fields Glaucoma Drainage Implants Antihypertensive Agents Glaucoma Open-Angle Intraocular Pressure |
| Zdroj: | Ophthalmology |
| ISSN: | 1549-4713 |
| Popis: | 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 will be enrolled at 16 Clinical Centers and randomly assigned to treatment with a tube shunt (350-mm(2) 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) > 21 mm Hg or reduced < 20% from baseline, IOP ≤ 5 mm Hg, 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 two most commonly performed glaucoma surgical procedures. |
| Databáze: | OpenAIRE |
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