Original article
Treatment Outcomes in the Tube Versus Trabeculectomy Study After One Year of Follow-up

https://doi.org/10.1016/j.ajo.2006.07.020Get rights and content

Purpose

To report one-year results of the Tube Versus Trabeculectomy (TVT) Study.

Design

Multicenter randomized clinical trial.

Methods

setting: 17 Clinical Centers. study population: Patients 18 to 85 years of age who had previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure (IOP) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: 350 mm2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). main outcome measures: IOP, visual acuity, and reoperation for glaucoma.

Results

A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At one year, IOP (mean ± SD) was 12.4 ± 3.9 mm Hg in the tube group and 12.7 ± 5.8 mm Hg in the trabeculectomy group (P = .73). The number of glaucoma medications (mean ± SD) was 1.3 ± 1.3 in the tube group and 0.5 ± 0.9 in the trabeculectomy group (P < .001). The cumulative probability of failure during the first year of follow-up was 3.9% in the tube group and 13.5% in the trabeculectomy group (P = .017).

Conclusions

Nonvalved tube shunt surgery was more likely to maintain IOP control and avoid persistent hypotony or reoperation for glaucoma than trabeculectomy with MMC during the first year of follow-up in the TVT Study. Both surgical procedures produced similar IOP reduction at one year, but there was less need for supplemental medical therapy following trabeculectomy with MMC.

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.

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