Trabeculectomy

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Steven J Gedde - One of the best experts on this subject based on the ideXlab platform.

  • the tube versus Trabeculectomy iris registry study cohort selection and follow up and comparisons to the randomized controlled trial
    American Journal of Ophthalmology, 2021
    Co-Authors: Elizabeth A Vanner, William J. Feuer, Catherine Q Sun, Matthew J Mcsoley, Patrice J Persad, Flora Lum, Scott P Kelly, Richard K Parrish, Ta C Chang, Steven J Gedde
    Abstract:

    Purpose To assess the feasibility of replicating a randomized controlled trial (RCT) with a cohort of eyes, from IRIS® Registry data, analogous to the Tube Versus Trabeculectomy (TVT) RCT cohort and compare characteristics and follow-up. Design Comparison of RCT and IRIS Registry cohorts and follow-up. Methods We identified a cohort of IRIS Registry eyes (2013-2017) that received either a glaucoma drainage implant (tube) or Trabeculectomy after a previous Trabeculectomy and/or cataract extraction; extracted clinical and demographic characteristics for baseline surgery and follow-up visits through 1 year; and compared treatment groups in the IRIS Registry cohort and this cohort to the TVT RCT cohort. Results The IRIS Registry cohort included 419 eyes: 183 (43.7%) Trabeculectomy; 236 (56.3%) tube. There were significant differences between treatment groups, including race (White: Trabeculectomy 61.8%, tube 44.9%; Black: Trabeculectomy 20.8%, tube 35.6%; P = .003) and the percentage of follow-up visits completed (Trabeculectomy 88.4%, tube 83.8%, P = .004). There were also significant differences between the TVT IRIS Registry cohort and the TVT RCT cohort in the percentage of follow-up visits completed (IRIS Registry 85.6%, RCT 96.1%, P Conclusion The TVT IRIS Registry cohort had several significant treatment group differences at baseline, whereas there had been none in the TVT RCT cohort. Follow-up in the TVT IRIS Registry cohort was inferior to that of the TVT RCT. Some data needed to refine the selection of eyes for the cohort were not available in the IRIS Registry.

  • outcomes of glaucoma drainage device implantation and Trabeculectomy with mitomycin c in glaucoma secondary to aniridia
    American Journal of Ophthalmology, 2021
    Co-Authors: Indira Durai, Srilekha Pallamparthy, George Varghese Puthuran, Hiruni Kaushalya Wijesinghe, Mohammed Sithiq Uduman, Subbaiah Ramasamy Krishnadas, Alan L Robin, Paul F Palmberg, Steven J Gedde
    Abstract:

    Purpose To compare the outcomes of Aurolab aqueous drainage implant (AADI; Aurolab) placement and Trabeculectomy with mitomycin C (MMC) in patients with glaucoma secondary to aniridia. Design Retrospective comparative interventional case series. Methods This study included patients with congenital aniridia who underwent AADI implantation or Trabeculectomy with MMC. Surgical failure was defined as IOP > 21 mm Hg or reduced Results A total of 30 eyes of 30 patients underwent surgical treatment, including 18 eyes that received an AADI and 12 eyes that had a Trabeculectomy with MMC. The cumulative probability of failure at 2 years was 11.1% (95% CI = 2.9%-37.6%) in the AADI group and 58.3% (95% CI = 33.5%-84.8%) in the Trabeculectomy group (P = .05, log-rank). At 2 years, IOP (mean ± SD) was 14.1 ± 2.8 mm Hg in the AADI group and 19.6 ± 6.6 mm Hg in the Trabeculectomy group (P = .02), and the number of glaucoma medications was 1.7 ± 0.9 in the AADI group and 2.2 ± 0.8 in the Trabeculectomy group (P = .25). Surgical complications developed in 1 patient in each treatment group (P = .65). Cataract surgery was performed in 5 (42%) patients in the Trabeculectomy group and no patients in the AADI group (P = .01). Conclusions Placement of an AADI resulted in lower IOP and a higher rate of surgical success compared to Trabeculectomy with MMC in eyes with glaucoma associated with aniridia. Cataract extraction was more frequently required after Trabeculectomy with MMC than AADI implantation.

  • Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
    Ophthalmology, 2018
    Co-Authors: Steven J Gedde, James D Brandt, Iqbal K. Ahmed, Keith Barton, William J. Feuer, Saurabh Goyal, Michael R. Banitt
    Abstract:

    Purpose To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design 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 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 Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the Trabeculectomy group ( P  = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20–5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the Trabeculectomy group at 1 year ( P  = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the Trabeculectomy group ( P P  = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the Trabeculectomy group ( P  = 0.03). Conclusions Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after Trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to Trabeculectomy with MMC.

  • A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C
    Ophthalmology, 2015
    Co-Authors: Joseph Panarelli, Steven J Gedde, Joyce C. Schiffman, Michael R. Banitt, William J. Feuer
    Abstract:

    Purpose To compare the safety and efficacy of Baerveldt implantation (Abbott Medical Optics, Santa Ana, CA) and Trabeculectomy with mitomycin C (MMC) in patients who have not undergone prior incisional ocular surgery. Design Retrospective, comparative case series. Participants A total of 125 patients with low-risk glaucoma undergoing primary glaucoma surgery, including 55 patients who received a 350-mm 2 Baerveldt glaucoma implant and 70 patients who underwent Trabeculectomy with MMC. Methods Eligible patients were identified using Current Procedural Terminology codes, and their medical records were reviewed retrospectively. Main Outcome Measures The primary outcome measure was surgical success (intraocular pressure [IOP] ≤21 mmHg and reduced ≥20% from baseline, IOP >5 mmHg, no reoperation for glaucoma, no loss of light-perception vision). Secondary outcome measures included visual acuity, IOP, number of glaucoma medications, and complications. Results The cumulative probability of success at 3 years with or without medical therapy was 87% in the Baerveldt group and 76% in the Trabeculectomy group ( P  = 0.23). Postoperative complications occurred in 11 patients (20%) in the Baerveldt group and 20 patients (29%) in the Trabeculectomy group ( P  = 0.27). Mean follow-up ± standard deviation was 27±19 months in the Baerveldt group and 34±20 months in the Trabeculectomy group ( P  = 0.053). Conclusions Similar rates of surgical success and postoperative complications were observed in patients undergoing Trabeculectomy with MMC and in those undergoing Baerveldt implantation during 3 years of follow-up. Both are viable primary glaucoma procedures in patients who have not undergone prior ocular surgery.

  • Outcomes of glaucoma reoperations in the tube versus Trabeculectomy (TVT) study
    American Journal of Ophthalmology, 2014
    Co-Authors: Hady Saheb, Steven J Gedde, Joyce C. Schiffman, William J. Feuer
    Abstract:

    Purpose To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study. Design Cohort study of patients in a multicenter randomized clinical trial. Methods The 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). Results Additional 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). Conclusions The 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.

William J. Feuer - One of the best experts on this subject based on the ideXlab platform.

  • the tube versus Trabeculectomy iris registry study cohort selection and follow up and comparisons to the randomized controlled trial
    American Journal of Ophthalmology, 2021
    Co-Authors: Elizabeth A Vanner, William J. Feuer, Catherine Q Sun, Matthew J Mcsoley, Patrice J Persad, Flora Lum, Scott P Kelly, Richard K Parrish, Ta C Chang, Steven J Gedde
    Abstract:

    Purpose To assess the feasibility of replicating a randomized controlled trial (RCT) with a cohort of eyes, from IRIS® Registry data, analogous to the Tube Versus Trabeculectomy (TVT) RCT cohort and compare characteristics and follow-up. Design Comparison of RCT and IRIS Registry cohorts and follow-up. Methods We identified a cohort of IRIS Registry eyes (2013-2017) that received either a glaucoma drainage implant (tube) or Trabeculectomy after a previous Trabeculectomy and/or cataract extraction; extracted clinical and demographic characteristics for baseline surgery and follow-up visits through 1 year; and compared treatment groups in the IRIS Registry cohort and this cohort to the TVT RCT cohort. Results The IRIS Registry cohort included 419 eyes: 183 (43.7%) Trabeculectomy; 236 (56.3%) tube. There were significant differences between treatment groups, including race (White: Trabeculectomy 61.8%, tube 44.9%; Black: Trabeculectomy 20.8%, tube 35.6%; P = .003) and the percentage of follow-up visits completed (Trabeculectomy 88.4%, tube 83.8%, P = .004). There were also significant differences between the TVT IRIS Registry cohort and the TVT RCT cohort in the percentage of follow-up visits completed (IRIS Registry 85.6%, RCT 96.1%, P Conclusion The TVT IRIS Registry cohort had several significant treatment group differences at baseline, whereas there had been none in the TVT RCT cohort. Follow-up in the TVT IRIS Registry cohort was inferior to that of the TVT RCT. Some data needed to refine the selection of eyes for the cohort were not available in the IRIS Registry.

  • Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up
    Ophthalmology, 2018
    Co-Authors: Steven J Gedde, James D Brandt, Iqbal K. Ahmed, Keith Barton, William J. Feuer, Saurabh Goyal, Michael R. Banitt
    Abstract:

    Purpose To report 1-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. Design 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 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 Intraocular pressure (IOP), glaucoma medical therapy, visual acuity, visual fields, surgical complications, and failure (IOP of more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision). Results The cumulative probability of failure during the first year of follow-up was 17.3% in the tube group and 7.9% in the Trabeculectomy group ( P  = 0.01; hazard ratio, 2.59; 95% confidence interval, 1.20–5.60). Mean ± standard deviation IOP was 13.8±4.1 mmHg in the tube group and 12.4±4.4 mmHg in the Trabeculectomy group at 1 year ( P  = 0.01), and the number of glaucoma medications was 2.1±1.4 in the tube group and 0.9±1.4 in the Trabeculectomy group ( P P  = 0.06). Serious complications requiring reoperation or producing a loss of 2 Snellen lines or more occurred in 1 patient (1%) in the tube group and 8 patients (7%) in the Trabeculectomy group ( P  = 0.03). Conclusions Trabeculectomy with MMC had a higher surgical success rate than tube shunt implantation after 1 year in the PTVT Study. Lower IOP with use of fewer glaucoma medications was achieved after Trabeculectomy with MMC compared with tube shunt surgery during the first year of follow-up. The frequency of serious complications producing vision loss or requiring reoperation was lower after tube shunt surgery relative to Trabeculectomy with MMC.

  • A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C
    Ophthalmology, 2015
    Co-Authors: Joseph Panarelli, Steven J Gedde, Joyce C. Schiffman, Michael R. Banitt, William J. Feuer
    Abstract:

    Purpose To compare the safety and efficacy of Baerveldt implantation (Abbott Medical Optics, Santa Ana, CA) and Trabeculectomy with mitomycin C (MMC) in patients who have not undergone prior incisional ocular surgery. Design Retrospective, comparative case series. Participants A total of 125 patients with low-risk glaucoma undergoing primary glaucoma surgery, including 55 patients who received a 350-mm 2 Baerveldt glaucoma implant and 70 patients who underwent Trabeculectomy with MMC. Methods Eligible patients were identified using Current Procedural Terminology codes, and their medical records were reviewed retrospectively. Main Outcome Measures The primary outcome measure was surgical success (intraocular pressure [IOP] ≤21 mmHg and reduced ≥20% from baseline, IOP >5 mmHg, no reoperation for glaucoma, no loss of light-perception vision). Secondary outcome measures included visual acuity, IOP, number of glaucoma medications, and complications. Results The cumulative probability of success at 3 years with or without medical therapy was 87% in the Baerveldt group and 76% in the Trabeculectomy group ( P  = 0.23). Postoperative complications occurred in 11 patients (20%) in the Baerveldt group and 20 patients (29%) in the Trabeculectomy group ( P  = 0.27). Mean follow-up ± standard deviation was 27±19 months in the Baerveldt group and 34±20 months in the Trabeculectomy group ( P  = 0.053). Conclusions Similar rates of surgical success and postoperative complications were observed in patients undergoing Trabeculectomy with MMC and in those undergoing Baerveldt implantation during 3 years of follow-up. Both are viable primary glaucoma procedures in patients who have not undergone prior ocular surgery.

  • Outcomes of glaucoma reoperations in the tube versus Trabeculectomy (TVT) study
    American Journal of Ophthalmology, 2014
    Co-Authors: Hady Saheb, Steven J Gedde, Joyce C. Schiffman, William J. Feuer
    Abstract:

    Purpose To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study. Design Cohort study of patients in a multicenter randomized clinical trial. Methods The 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). Results Additional 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). Conclusions The 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.

  • the tube versus Trabeculectomy study interpretation of results and application to clinical practice
    Current Opinion in Ophthalmology, 2012
    Co-Authors: Steven J Gedde, Joyce C. Schiffman, Kuldev Singh, William J. Feuer
    Abstract:

    Purpose of review 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 C (MMC) in eyes with previous cataract and/or failed glaucoma surgery. This article interprets results from the TVT Study and applies them to clinical practice. Recent findings Both tube-shunt surgery and Trabeculectomy with MMC produced intraocular pressure (IOP) reduction to the low teens throughout the 5-year duration of the study. Tube-shunt surgery was associated with use of more glaucoma medications than Trabeculectomy with MMC during the first 2 years of the study, but medical therapy equalized with longer follow-up. Trabeculectomy with MMC had higher rates of surgical failure and reoperation for glaucoma compared with tube-shunt surgery. Vision loss occurred at a similar rate with the two surgical procedures. Early complications were more frequent after Trabeculectomy with MMC relative to tube-shunt surgery, but both procedures had similar rates of late postoperative complications and serious complications. Summary Tube-shunt surgery and Trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients who have undergone prior cataract and/or failed filtering surgery. Results of the TVT Study support the expanding use of tube shunts beyond refractory glaucomas.

Joyce C. Schiffman - One of the best experts on this subject based on the ideXlab platform.

  • A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C
    Ophthalmology, 2015
    Co-Authors: Joseph Panarelli, Steven J Gedde, Joyce C. Schiffman, Michael R. Banitt, William J. Feuer
    Abstract:

    Purpose To compare the safety and efficacy of Baerveldt implantation (Abbott Medical Optics, Santa Ana, CA) and Trabeculectomy with mitomycin C (MMC) in patients who have not undergone prior incisional ocular surgery. Design Retrospective, comparative case series. Participants A total of 125 patients with low-risk glaucoma undergoing primary glaucoma surgery, including 55 patients who received a 350-mm 2 Baerveldt glaucoma implant and 70 patients who underwent Trabeculectomy with MMC. Methods Eligible patients were identified using Current Procedural Terminology codes, and their medical records were reviewed retrospectively. Main Outcome Measures The primary outcome measure was surgical success (intraocular pressure [IOP] ≤21 mmHg and reduced ≥20% from baseline, IOP >5 mmHg, no reoperation for glaucoma, no loss of light-perception vision). Secondary outcome measures included visual acuity, IOP, number of glaucoma medications, and complications. Results The cumulative probability of success at 3 years with or without medical therapy was 87% in the Baerveldt group and 76% in the Trabeculectomy group ( P  = 0.23). Postoperative complications occurred in 11 patients (20%) in the Baerveldt group and 20 patients (29%) in the Trabeculectomy group ( P  = 0.27). Mean follow-up ± standard deviation was 27±19 months in the Baerveldt group and 34±20 months in the Trabeculectomy group ( P  = 0.053). Conclusions Similar rates of surgical success and postoperative complications were observed in patients undergoing Trabeculectomy with MMC and in those undergoing Baerveldt implantation during 3 years of follow-up. Both are viable primary glaucoma procedures in patients who have not undergone prior ocular surgery.

  • Outcomes of glaucoma reoperations in the tube versus Trabeculectomy (TVT) study
    American Journal of Ophthalmology, 2014
    Co-Authors: Hady Saheb, Steven J Gedde, Joyce C. Schiffman, William J. Feuer
    Abstract:

    Purpose To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study. Design Cohort study of patients in a multicenter randomized clinical trial. Methods The 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). Results Additional 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). Conclusions The 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.

  • the tube versus Trabeculectomy study interpretation of results and application to clinical practice
    Current Opinion in Ophthalmology, 2012
    Co-Authors: Steven J Gedde, Joyce C. Schiffman, Kuldev Singh, William J. Feuer
    Abstract:

    Purpose of review 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 C (MMC) in eyes with previous cataract and/or failed glaucoma surgery. This article interprets results from the TVT Study and applies them to clinical practice. Recent findings Both tube-shunt surgery and Trabeculectomy with MMC produced intraocular pressure (IOP) reduction to the low teens throughout the 5-year duration of the study. Tube-shunt surgery was associated with use of more glaucoma medications than Trabeculectomy with MMC during the first 2 years of the study, but medical therapy equalized with longer follow-up. Trabeculectomy with MMC had higher rates of surgical failure and reoperation for glaucoma compared with tube-shunt surgery. Vision loss occurred at a similar rate with the two surgical procedures. Early complications were more frequent after Trabeculectomy with MMC relative to tube-shunt surgery, but both procedures had similar rates of late postoperative complications and serious complications. Summary Tube-shunt surgery and Trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients who have undergone prior cataract and/or failed filtering surgery. Results of the TVT Study support the expanding use of tube shunts beyond refractory glaucomas.

  • Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    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.

  • Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Donald L Budenz, William J. Feuer, Joyce C. Schiffman
    Abstract:

    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-mm 2 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.

Donald L Budenz - One of the best experts on this subject based on the ideXlab platform.

  • Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    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.

  • Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Donald L Budenz, William J. Feuer, Joyce C. Schiffman
    Abstract:

    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-mm 2 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.

  • Three-Year Follow-up of the Tube Versus Trabeculectomy Study
    American Journal of Ophthalmology, 2009
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    Abstract:

    Purpose To report 3-year results of the Tube Versus Trabeculectomy (TVT) Study. Design Multicenter randomized clinical trial. Methods setting: Seventeen clinical centers. study population: Patients 18 to 85 years of age who had previous Trabeculectomy, cataract extraction with intraocular lens implantation, or both and uncontrolled glaucoma with intraocular pressure (IOP) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 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, surgical complications, 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 3 years, IOP (mean ± standard deviation [SD]) was 13.0 ± 4.9 mm Hg in the tube group and 13.3 ± 6.8 mm Hg in the Trabeculectomy group ( P = .78). The number of glaucoma medications (mean ± SD) was 1.3 ± 1.3 in the tube group and 1.0 ± 1.5 in the Trabeculectomy group ( P = .30). The cumulative probability of failure during the first 3 years of follow-up was 15.1% in the tube group and 30.7% in the Trabeculectomy group ( P = .010; hazards ratio, 2.2; 95% confidence interval, 1.2 to 4.1). Postoperative complications developed in 42 patients (39%) in the tube group and 63 patients (60%) in the Trabeculectomy group ( P = .004). Surgical complications were associated with reoperation and/or loss of ≥2 Snellen lines in 24 patients (22%) in the tube group and 28 patients (27%) in the Trabeculectomy group ( P = .58). Conclusions Tube shunt surgery had a higher success rate compared to Trabeculectomy with MMC during the first 3 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 3 years. While the incidence of postoperative complications was higher following Trabeculectomy with MMC relative to tube shunt surgery, most complications were transient and self-limited.

  • Treatment Outcomes in the Tube Versus Trabeculectomy Study After One Year of Follow-up
    American Journal of Ophthalmology, 2006
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    Abstract:

    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 mm 2 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 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.

  • Surgical Complications in the Tube Versus Trabeculectomy Study During the First Year of Follow-up
    American Journal of Ophthalmology, 2006
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Donald L Budenz, William J. Feuer, Joyce C. Schiffman
    Abstract:

    Purpose To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study. Design Multicenter randomized clinical trial. Methods setting: Seventeen clinical centers. study population: Two hundred twelve patients aged 18 to 85 years who had undergone previous Trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 350-mm 2 Baerveldt glaucoma implant or Trabeculectomy with mitomycin C (MMC). main outcome measures: Surgical complications, reoperation for complications, visual acuity, and cataract progression. Results Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the Trabeculectomy group ( P = .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the Trabeculectomy group during the first year of follow-up ( P = .001). Surgical complications were associated with reoperation and/or loss of ≥2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the Trabeculectomy group ( P = .12). Conclusions There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after Trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures.

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  • Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    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.

  • Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up
    American Journal of Ophthalmology, 2012
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Donald L Budenz, William J. Feuer, Joyce C. Schiffman
    Abstract:

    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-mm 2 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.

  • a comparison of the ex press mini glaucoma shunt with standard Trabeculectomy in the surgical treatment of glaucoma
    Ophthalmic Surgery Lasers & Imaging, 2011
    Co-Authors: Lionel A Marzette, Leon W. Herndon
    Abstract:

    Background and objective To compare the success and complication rates of patients with glaucoma who had an Ex-PRESS mini glaucoma shunt device implantation (Optonol, Ltd., Neve Ilan, Israel) to those who had conventional Trabeculectomy. Patients and methods The records of 76 eyes of 69 consecutive subjects who had Ex-PRESS implants and 77 eyes of 65 consecutive controls who had Trabeculectomy procedures were reviewed. All surgeries were performed by one of the authors (LWH). Success was defined as an intraocular pressure (IOP) between 5 and 21 mm Hg in patients who did not require further glaucoma surgery in the eye of note. Results The difference in the percentage of cases of postoperative hypotony between the standard Trabeculectomy group (16%) and the Ex-PRESS group (4%) was statistically significant (P = .023). Conclusion The Ex-PRESS device is at least as effective as the standard Trabeculectomy in lowering the IOP of patients with glaucoma, with a significantly lower risk of postoperative hypotony. The data further suggest that the Ex-PRESS device results in an overall greater percentage reduction in IOP than with Trabeculectomy, although this did not reach statistical significance.

  • Three-Year Follow-up of the Tube Versus Trabeculectomy Study
    American Journal of Ophthalmology, 2009
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    Abstract:

    Purpose To report 3-year results of the Tube Versus Trabeculectomy (TVT) Study. Design Multicenter randomized clinical trial. Methods setting: Seventeen clinical centers. study population: Patients 18 to 85 years of age who had previous Trabeculectomy, cataract extraction with intraocular lens implantation, or both and uncontrolled glaucoma with intraocular pressure (IOP) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 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, surgical complications, 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 3 years, IOP (mean ± standard deviation [SD]) was 13.0 ± 4.9 mm Hg in the tube group and 13.3 ± 6.8 mm Hg in the Trabeculectomy group ( P = .78). The number of glaucoma medications (mean ± SD) was 1.3 ± 1.3 in the tube group and 1.0 ± 1.5 in the Trabeculectomy group ( P = .30). The cumulative probability of failure during the first 3 years of follow-up was 15.1% in the tube group and 30.7% in the Trabeculectomy group ( P = .010; hazards ratio, 2.2; 95% confidence interval, 1.2 to 4.1). Postoperative complications developed in 42 patients (39%) in the tube group and 63 patients (60%) in the Trabeculectomy group ( P = .004). Surgical complications were associated with reoperation and/or loss of ≥2 Snellen lines in 24 patients (22%) in the tube group and 28 patients (27%) in the Trabeculectomy group ( P = .58). Conclusions Tube shunt surgery had a higher success rate compared to Trabeculectomy with MMC during the first 3 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 3 years. While the incidence of postoperative complications was higher following Trabeculectomy with MMC relative to tube shunt surgery, most complications were transient and self-limited.

  • Treatment Outcomes in the Tube Versus Trabeculectomy Study After One Year of Follow-up
    American Journal of Ophthalmology, 2006
    Co-Authors: Steven J Gedde, James D Brandt, Leon W. Herndon, Joyce C. Schiffman, William J. Feuer, Donald L Budenz
    Abstract:

    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 mm 2 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 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.

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