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Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up.

Abstract

PURPOSE

To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study.

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-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes).

MAIN OUTCOME MEASURES

IOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, reoperation for glaucoma, or loss of light perception vision).

RESULTS

A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, IOP (mean ± SD) was 14.4 ± 6.9 mm Hg in the tube group and 12.6 ± 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean ± SD) was 1.4 ± 1.3 in the tube group and 1.2 ± 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025).

CONCLUSIONS

Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement.

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  • Authors+Show Affiliations

    ,

    Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Florida, USA. sgedde@med.miami.edu

    , , , , ,

    Source

    American journal of ophthalmology 153:5 2012 May pg 789-803.e2

    MeSH

    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Alkylating Agents
    Antihypertensive Agents
    Cataract Extraction
    Combined Modality Therapy
    Female
    Follow-Up Studies
    Glaucoma
    Glaucoma Drainage Implants
    Humans
    Intraocular Pressure
    Lens Implantation, Intraocular
    Male
    Middle Aged
    Mitomycin
    Reoperation
    Tonometry, Ocular
    Trabeculectomy
    Treatment Outcome
    Visual Acuity

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22245458

    Citation

    Gedde, Steven J., et al. "Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up." American Journal of Ophthalmology, vol. 153, no. 5, 2012, pp. 789-803.e2.
    Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5):789-803.e2.
    Gedde, S. J., Schiffman, J. C., Feuer, W. J., Herndon, L. W., Brandt, J. D., & Budenz, D. L. (2012). Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. American Journal of Ophthalmology, 153(5), pp. 789-803.e2. doi:10.1016/j.ajo.2011.10.026.
    Gedde SJ, et al. Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up. Am J Ophthalmol. 2012;153(5):789-803.e2. PubMed PMID: 22245458.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. AU - Gedde,Steven J, AU - Schiffman,Joyce C, AU - Feuer,William J, AU - Herndon,Leon W, AU - Brandt,James D, AU - Budenz,Donald L, AU - ,, Y1 - 2012/01/15/ PY - 2011/06/08/received PY - 2011/10/19/revised PY - 2011/10/20/accepted PY - 2012/1/17/entrez PY - 2012/1/17/pubmed PY - 2012/6/15/medline SP - 789 EP - 803.e2 JF - American journal of ophthalmology JO - Am. J. Ophthalmol. VL - 153 IS - 5 N2 - PURPOSE: To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study. 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-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES: IOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, reoperation for glaucoma, or loss of light perception vision). RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, IOP (mean ± SD) was 14.4 ± 6.9 mm Hg in the tube group and 12.6 ± 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean ± SD) was 1.4 ± 1.3 in the tube group and 1.2 ± 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025). CONCLUSIONS: Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement. SN - 1879-1891 UR - https://www.unboundmedicine.com/medline/citation/22245458/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9394(11)00847-6 DB - PRIME DP - Unbound Medicine ER -