Original articleTreatment Outcomes in the Tube Versus Trabeculectomy Study After One Year of Follow-up
Section snippets
Methods
The Institutional Review Board at each Clinical Center approved the study protocol before recruitment was started, and each patient gave informed consent. The study was registered at www.clinicaltrials.gov. The design and methods of the TVT Study were previously described in detail,29 and they are summarized as follows.
Recruitment and retention
A total of 212 patients were enrolled in the TVT Study between October 1999 and April 2004. Randomization assigned 107 patients to placement of a 350 mm2 Baerveldt glaucoma implant and 105 patients to trabeculectomy with MMC. All patients received their assigned treatment.
The progress of patients in the study is shown in Figure 1. In the overall study group, four patients died within one year of enrollment. There were 19 other patients who missed the one-year follow-up visit, but 10 of these
Discussion
The TVT Study enrolled patients with medically uncontrolled glaucoma who had undergone previous cataract extraction with intraocular lens implantation and/or failed filtering surgery and randomized them to surgical treatment with trabeculectomy with MMC or placement of a Baerveldt glaucoma implant. Both surgical procedures were effective in lowering IOP. Among patients who completed one-year follow-up visits, trabeculectomy with MMC produced a 49.5% reduction in IOP and placement of a Baerveldt
Steven J. Gedde, MD, is an Associate Professor of Ophthalmology and Residency Program Director at the Bascom Palmer Eye Institute, Miami, Florida. He is a study chairman in the Tube Versus Trabeculectomy Study (TVT). Dr Gedde research interests include glaucoma drainage implants, complications of glaucoma surgery, quality of life, and resident education.
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Cited by (0)
Steven J. Gedde, MD, is an Associate Professor of Ophthalmology and Residency Program Director at the Bascom Palmer Eye Institute, Miami, Florida. He is a study chairman in the Tube Versus Trabeculectomy Study (TVT). Dr Gedde research interests include glaucoma drainage implants, complications of glaucoma surgery, quality of life, and resident education.
Supplemental Material available at AJO.com.
See accompanying Article on page 23 and Editorial on page 141.