Original article
Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up

https://doi.org/10.1016/j.ajo.2011.10.024Get rights and content

Purpose

To describe postoperative complications encountered in the Tube Versus Trabeculectomy (TVT) Study during 5 years of follow-up.

Design

Multicenter randomized clinical trial.

Methods

settings: Seventeen 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: Tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC 0.4 mg/mL for 4 minutes). main outcome measures: Surgical complications, reoperations for complications, visual acuity, and cataract progression.

Results

Early postoperative complications occurred in 22 patients (21%) in the tube group and 39 patients (37%) in the trabeculectomy group (P = .012). Late postoperative complications developed in 36 patients (34%) in the tube group and 38 patients (36%) in the trabeculectomy group during 5 years of follow-up (P = .81). The rate of reoperation for complications was 22% in the tube group and 18% in the trabeculectomy group (P = .29). Cataract extraction was performed in 13 phakic eyes (54%) in the tube group and 9 phakic eyes (43%) in the trabeculectomy group (P = .43).

Conclusions

A large number of surgical complications were observed in the TVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, reoperation for complications, and cataract extraction were similar with both surgical procedures after 5 years of follow-up.

Section snippets

Study Design

The study protocol is described in detail in a previous publication.2 In brief, patients 18 to 85 years of age who had previous cataract extraction with intraocular lens implantation and/or trabeculectomy with IOP ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy were enrolled in the study. Baseline demographic and clinical information were collected for each patient. One eye of each eligible patient was randomized to placement of a 350-mm2 Baerveldt glaucoma implant (Abbott Medical

Recruitment and Surgical Treatment

A total of 212 eyes of 212 patients were enrolled in the TVT Study, including 107 patients who underwent placement of a tube shunt and 105 patients who had a trabeculectomy with MMC. All patients received their assigned treatment. Additional details on operative data and intraoperative complications were provided in a previous publication.3

Postoperative Interventions

Table 1 lists postoperative interventions. Most interventions occurred in the early postoperative period and were previously reported.3 The frequency of

Discussion

The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery to trabeculectomy with MMC in patients who had previous cataract and/or filtering surgery. Early postoperative complications occurred more frequently after trabeculectomy with MMC than after tube shunt surgery. The rates of late postoperative complications and reoperation for complications were similar with both surgical procedures during 5 years of follow-up. However, all surgical

Steven J. Gedde, MD, is a 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 and Primary Tube Versus Trabeculectomy Study. His 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 a 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 and Primary Tube Versus Trabeculectomy Study. His research interests include glaucoma drainage implants, complications of glaucoma surgery, quality of life, and resident education.

    See Accompanying Editorial on page 787.

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