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.
Evidence-based update of the Primary Open-Angle Glaucoma Preferred Practice Pattern® (PPP) guidelines, describing the diagnosis and management of patients with primary open-angle glaucoma with an algorithm for patient management and detailed recommendations for evaluation and treatment options.
This study determines the relation between visual field impairment, visual functioning, and global quality of life in patients with glaucoma. Binocular visual field impairment was calculated from simultaneous Esterman visual field testing using the Humphrey automated perimeter. Visual acuity impairment, defined with the American Medical Association's Guides to the Evaluation of Permanent Impairment; visual functioning, measured with the VF-14 and the field test version of the National Eye Institute-Visual Functioning Questionnaire; and global quality of life, assessed with the Medical Outcomes Study 36-Item Short Form Health Survey, were determined in 147 consecutive patients with glaucoma. None of the Medical Outcomes Study 36-Item Short Form HealthSurvey domains demonstrated more than a weak correlation with visual field impairment. scores were moderately correlated (r=-0.58). Of the National Eye Institute-Visual Functioning Questionnaire scales, peripheral vision (r=\m=-\0.60), distance activities (r=\m=-\0.56), and vision-specific dependency (r=\m=-\0.56) were moderately correlated with visual field impairment; vision-specific social functioning, near activities, vision-specific role difficulties, general vision, vision-specific mental health, color vision, and driving were modestly correlated with visual field impairment (r value between \m=-\0.32and \m=-\0.55); visual pain was weakly correlated with visual field impairment; and general health and vision\x=req-\ specific expectations were not notably correlated with visual field impairment. Statistically adjusting for visual acuity weakened the correlations. The Medical Outcomes Study 36-Item Short Form Health Survey indicated that our patients with glaucoma were comparable with previously studied patients without severe systemic medical problems. However, the Medical Outcomes Study 36-Item Short Form Health Survey scores did not correlate with visual field impairment in our study. Based on the moderate correlation between binocular visual field impairment with the VF-14 and the National Eye Institute-Visual Functioning Questionnaire, these questionnaires may be useful among patients with glaucoma.
Purpose: To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study. Design: Unmasked multicenter randomized clinical trial. Participants: Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group.Methods: Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).Main Outcome Measures: The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications.Results: The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P ¼ 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9e2.2). Mean AE standard deviation IOP was 14.0AE4.2 mmHg in the tube group and 12.1AE4.8 mmHg in the trabeculectomy group at 3 years (P ¼ 0.008), and the number of glaucoma medications was 2.1AE1.4 in the tube group and 1.2AE1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P ¼ 0.11).Conclusions: There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures. Ophthalmology 2020;127:333-345 ª 2019 by the American Academy of Ophthalmology Supplemental material available at www.aaojournal.org.Johnson Vision, Santa Ana, CA) or trabeculectomy with MMC. The goal of this investigator-initiated study was to offer information that will assist in surgical decision making in similar patient groups. The methodology and outcomes during the first postoperative year are described in previous publications. 6,7 The primary outcome measure in the PTVT Study was the cumulative rate of surgical failure at 1 year. The present report provides 3-year follow-up data on enrolled patients.
MethodsThe study was approved by the institutional review board at each clinical center before recruitment was initiated (see Appendix,
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