The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.
Ophthalmology
; 125(5): 774-781, 2018 05.
Article
em En
| MEDLINE
| ID: mdl-29248173
ABSTRACT
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 OUTCOMEMEASURES:
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Trabeculectomia
/
Mitomicina
/
Implantação de Prótese
/
Implantes para Drenagem de Glaucoma
/
Alquilantes
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Ophthalmology
Ano de publicação:
2018
Tipo de documento:
Article