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Results from the tube versus trabeculectomy study.

ABSTRACT: The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery to trabeculectomy with mitomycin (MMC) in eyes with previous cataract and/or failed glaucoma surgery. Tube shunt surgery was more likely to maintain intraocular pressure (IOP) control and avoid persistent hypotony, reoperation for glaucoma, or loss of light perception vision than trabeculectomy with MMC during the first year of follow-up. Both surgical procedures had similar IOP reduction at 1 year, but less supplemental medical therapy was used following trabeculectomy. The incidence of postoperative complications was higher after trabeculectomy with MMC relative to tube shunt surgery, but serious complications associated with vision loss and/or reoperation developed with similar frequency after both of the procedures. There was no significant difference in the rate of vision loss following trabeculectomy with MMC and tube shunt surgery after 1 year of follow-up. Cataract progression was common, but occurred with similar frequency with both of the surgical procedures.

SUBMITTER: Gedde SJ

PROVIDER: S-EPMC2813602 | biostudies-literature | 2009 Jul

REPOSITORIES: biostudies-literature

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Results from the tube versus trabeculectomy study.

Gedde Steven J SJ

Middle East African journal of ophthalmology 20090701 3

The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery to trabeculectomy with mitomycin (MMC) in eyes with previous cataract and/or failed glaucoma surgery. Tube shunt surgery was more likely to maintain intraocular pressure (IOP) control and avoid persistent hypotony, reoperation for glaucoma, or loss of light perception vision than trabeculectomy with MMC during the first year of follow-up. Both surgical pro ...[more]

PMID: 20142972

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Project description:PurposeTo describe visual field (VF) outcomes in the Tube Versus Trabeculectomy (TVT) Study.DesignCohort analysis of patients in a multicenter randomized clinical trial.ParticipantsA total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups.MethodsThe TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm2 Baerveldt implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 4 minutes) in patients with previous cataract or glaucoma surgery. Enrolled patients underwent perimetry at baseline and annual follow-up visits. The VFs were included if the false-positive rate was ≤20% and false-negative rate was ≤35%. The VFs were excluded if visual acuity <20/400 or loss of ≥2 Snellen lines from baseline was attributed to an etiology other than glaucoma. Longitudinal linear mixed-effects models with best linear unbiased predictions (BLUPs) were applied to estimate rates of change in mean deviation (MD) for each treatment group.Main outcome measureRate of MD change during follow-up period.ResultsA total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07 ± 8.4 decibels (dB) in the tube shunt group and -13.18 ± 8.2 dB in the trabeculectomy group (P = 0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (P = 0.34). The 95% confidence intervals for the rates of MD change were -0.77 to -0.44 dB/year in the tube group and -0.56 to -0.20 dB/year in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) <18 mmHg or by average IOP. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss.ConclusionsSlow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.

Project description:PurposeTo describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study.DesignCohort study of patients in a multicenter randomized clinical trial.MethodsThe TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. Randomization assigned 107 patients to surgery with a tube shunt (350 mm(2) Baerveldt glaucoma implant) and 105 patients to trabeculectomy with mitomycin C (0.4 mg/mL for 4 minutes). Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery. Outcome measures included intraocular pressure (IOP), use of glaucoma medications, visual acuity, surgical complications, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, additional glaucoma surgery, or loss of light perception vision).ResultsAdditional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study, and the 5-year cumulative reoperation rate was 9% in the tube group and 29% in the trabeculectomy group (P = .025). Follow-up (mean ± SD) after additional glaucoma surgery was 28.0 ± 16.0 months in the tube group and 30.5 ± 20.4 months in the trabeculectomy group (P = .76). At 2 years after a glaucoma reoperation, IOP (mean ± SD) was 15.0 ± 5.5 mm Hg in the tube group and 14.4 ± 6.6 mm Hg in the trabeculectomy group (P = .84). The number of glaucoma medications (mean ± SD) after 2 years of follow-up was 1.1 ± 1.3 in the tube group and 1.4 ± 1.4 in the trabeculectomy group (P = .71). The cumulative probability of failure at 1, 2, 3, and 4 years after additional glaucoma surgery was 0%, 43%, 43%, and 43%, respectively, in the tube group, and 0%, 9%, 20%, and 47% in the trabeculectomy group (P = .28). Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group (P = .63).ConclusionsThe rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study. Similar surgical outcomes were observed after additional glaucoma surgery, irrespective of initial randomized treatment in the study.

Project description:PurposeTo describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.DesignMulticenter randomized clinical trial.ParticipantsA total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.MethodsPatients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes).Main outcome measuresSurgical complications, reoperations for complications, visual acuity, and cataract progression.ResultsEarly postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.

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Results from the tube versus trabeculectomy study.

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Results from the tube versus trabeculectomy study.

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